Surgical offloading procedures for diabetic foot ulcers compared to best non-surgical treatment: a study protocol for a randomized controlled trial Preventing diabetic foot disease: lessons from the Medicare therapeutic shoe demonstration. Randomized controlled trial for clinical effects of varying types of insoles combined with specialized shoes in patients with rheumatoid arthritis of the foot. Efficacy of custom foot orthotics in improving pain and functional status in children with juvenile idiopathic arthritis: a randomized trial. Effect of therapeutic footwear on foot reulceration in patients with diabetes: a randomized controlled trial. [Orthopedic made-to-measure shoes for diabetics. Long-term 5-year outcome]. Manufactured Shoes in the Prevention of Diabetic Foot Ulcers [Insoles for the rheumatic foot. A clinical and pedobarographic analysis]. [Preventing high-risk diabetic foot ulceration by a new method of custom-made shoes in high-risk patients. Prospective study]. Reduction of peak plantar pressure in people with diabetes-related peripheral neuropathy: an evaluation of the DH Pressure Relief Shoe™ A consensus definition and rating scale for minimalist shoes Outpatient Treatment of Unilateral Diabetic Foot Ulcers with ‘Half Shoes’ Effectiveness of a new brand of stock 'diabetic' shoes to protect against diabetic foot ulcer relapse. A prospective cohort study. Influence of a custom foot orthotic intervention on lower extremity dynamics in healthy runners. The Role of Footwear in the Prevention of Foot Lesions in Patients With NIDDM: Conventional wisdom or evidence-based practice? The effect of different shoes on functional mobility and energy expenditure in post-stroke hemiplegic patients using ankle–foot orthosis Off-loading the diabetic foot wound: a randomized clinical trial. Shoe characteristics and balance in older women. The effect of three different levels of footwear stability on pain outcomes in women runners: a randomised control trial Relationship between footwear comfort of shoe inserts and anthropometric and sensory factors. Custom-Made Orthesis and Shoes in a Structured Follow-Up Program Reduces the Incidence of Neuropathic Ulcers in High-Risk Diabetic Foot Patients Comparison of Custom and Prefabricated Orthoses in the Initial Treatment of Proximal Plantar Fasciitis Comparison of plantar pressure in three types of insole given to patients with diabetes at risk of developing foot ulcers – A two-year, randomized trial*
Background Diabetic foot ulcers are frequently related to elevated pressure under a bony prominence . Conservative treatment includes offloading with orthopaedic shoes and custom made orthotics or plaster casts . While casting in plaster is usually effective in achieving primary closure of foot ulcers , recurrence rates are high . Minimally invasive surgical offloading that includes correction of foot deformities has good short and long term results . The surgery alleviates the pressure under the bony prominence , thus enabling prompt ulcer healing , negating the patient ’s dependence on expensive shoes and orthotics , with a lower chance of recurrence . The purpose of this protocol is to compare offloading surgery ( percutaneous flexor tenotomy , mini-invasive floating metatarsal osteotomy or Keller arthroplasty ) to non-surgical treatment for patients with diabetic foot ulcers in a semi-crossover design ed RCT . Methods One hundred patients with diabetic neuropathy related foot ulcers ( tip of toe ulcers , ulcers under metatarsal heads and ulcers under the hallux interphalangeal joint ) will be r and omized ( 2:3 ) to a surgical offloading procedure or best available non-surgical treatment . Group 1 ( surgery ) will have surgery within 1 week . Group 2 ( controls ) will be prescribed an offloading cast applied for up to 12 weeks ( based on clinical considerations ) . Following successful offloading treatment ( ulcer closure with complete epithelization ) patients will be prescribed orthopaedic shoes and custom made orthotics . If offloading by cast for at least 6 weeks fails , or the ulcer recurs , patients will be offered surgical offloading . Follow-up will take place till 2 years following r and omization . Outcome criteria will be time to healing of the primary ulcer ( complete epithelization ) , time to healing of surgical wound , recurrence of ulcer , time to recurrence and complications . Discussion The high recurrence rate of foot ulcers and their dire consequences justify attempts to find better solutions than the non-surgical options available at present . To promote surgery , RCT level evidence of efficacy is necessary . Trial registration Israel MOH_2017–08 - 10_000719 . NIH : NCT03414216 OBJECTIVES Every year about 38,000 elderly people with diabetes have a  lower extremity amputation .  Therapeutic shoes are prescribed by clinicians specializing in foot care to prevent foot ulcerations and amputations among at-risk patients with diabetes . Medicare ran a 3-year demonstration of a therapeutic-shoe benefit for beneficiaries with diabetes . Medicare added the benefit nationwide in May 1993 . METHODS This paper describes the benefit and its implementation in the demonstration based on demonstration records , a patient survey , and discussion s with clinicians and shoe suppliers before and during the demonstration . RESULTS During the demonstration , far fewer beneficiaries applied for the therapeutic shoes than were eligible for them . The paper discusses reasons for the low beneficiary application rate and the associated low participation rate among physicians treating patients with diabetes . CONCLUSIONS The benefit is unlikely to be used any more in the national program than in the demonstration unless physicians are educated in the role therapeutic shoes can play in diabetic foot disease , they prescribe the shoes for their patients , and they increase their patients ' awareness of the shoes ' value OBJECTIVE To determine the effects of specialized shoes with insoles in patients with rheumatoid arthritis and the differences in terms of type of insole and anatomical location of foot pathology . DESIGN Single-blinded r and omized controlled trial . SETTING Out patients of physical medicine and rehabilitation clinic at university hospital . SUBJECTS Forty-two patients with rheumatoid foot lesions were r and omly assigned to two different orthotic intervention groups . The anatomical locations of the foot lesions were recorded ( hindfoot or forefoot ) . INTERVENTION Participants were provided with an extra deep forefoot-rockered shoe and either a custom-made semi-rigid insole or a ready-made simple soft insole . They wore the provided footwear for at least 3 hours a day over six months . MAIN OUTCOME MEASURES Primary outcome measures were foot pain visual analogue scale ( VAS ) scores and Foot Function Index ( FFI ) . Secondary outcome measures were erythrocyte sedimentation rate and C-reactive protein levels in blood , amounts of medications and active joint counts . These were checked at baseline and post intervention . RESULTS Eight patients dropped out at follow-up after six months of treatment . At six-month follow-ups , VAS scores and total Foot Function Index scores had decreased significantly in both groups versus baseline but intergroup comparison showed no significant differences in view of type of insoles and anatomical locations of foot pathology . CONCLUSIONS We were unable to identify differences between the types of insoles in terms of their clinical effects or between anatomical locations of foot lesions in the two groups , but both groups improved . Therapeutic shoes plus soft insoles might be effective enough in terms of foot pain and foot function for specific patients with rheumatoid foot problems regardless of the location of foot pathology OBJECTIVE . To compare the clinical efficacy of custom foot orthotics , prefabricated " off-the-shelf " shoe inserts , and supportive athletic shoes worn alone , on reducing pain and improving function for children with juvenile idiopathic arthritis ( JIA ) . METHODS Children with JIA and foot pain ( n = 40 ) were r and omized to one of 3 groups receiving : ( 1 ) custom-made semirigid foot orthotics with shock absorbing posts ( n = 15 ) , ( 2 ) off-the-shelf flat neoprene shoe inserts ( n = 12 ) , or ( 3 ) supportive athletic shoes with a medial longitudinal arch support and shock absorbing soles worn alone ( n = 13 ) . Foot pain and functional limitations were measured using the Pediatric Pain Question naire-visual analog scale ( VAS ) , Timed Walking , Foot Function Index ( FFI ) , and the Physical Functioning Subscale of the Pediatric Quality of Life Inventory ( PedsQL ) . Measures were administered by personnel blinded to group status at baseline ( before wearing the assigned intervention ) and at 3 months ' followup . RESULTS Children in the orthotics group showed significantly greater improvements in overall pain ( p = 0.009 ) , speed of ambulation ( p = 0.013 ) , activity limitations ( p = 0.002 ) , foot pain ( p = 0.019 ) , and level of disability ( p = 0.024 ) when compared with the other 2 groups . Both children and parents in the orthotics group reported clinical ly meaningful improvement in child health-related quality of life , although the group by time interaction did not show statistical significance . Except for a reduction in pain for supportive athletic shoes ( paired t test , p = 0.011 ) , neither the off-the-shelf shoe inserts nor the supportive athletic shoes worn alone showed significant effect on any of the evaluation measures . CONCLUSION In children with JIA , custom-made semirigid foot orthotics with shock-absorbing posts significantly improve pain , speed of ambulation , and self-rated activity and functional ability levels compared with prefabricated off-the-shelf shoe inserts or supportive athletic shoes worn alone CONTEXT Many people with diabetes experience lower-limb ulcers . Footwear has been implicated as a primary cause of foot ulcers , yet research is limited on the efficacy of shoe and insert combinations to prevent reulceration . OBJECTIVE To determine whether extra-depth and -width therapeutic shoes used with 2 types of inserts reduce reulceration in diabetic individuals with a history of foot ulcer . DESIGN , SETTING , AND PARTICIPANTS R and omized clinical trial of 400 diabetes patients with history of foot ulcer in 2 Washington State health care organizations who did not require custom shoes for foot deformity and were enrolled between August 1997 and December 1998 and followed up for 2 years . Data collected at regular intervals documented physical , foot , and diabetes characteristics ; footwear use ; foot lesions ; and ulcers . INTERVENTIONS Participants were r and omly assigned to receive 3 pairs of therapeutic shoes and 3 pairs of customized medium-density cork inserts with a neoprene closed-cell cover ( n = 121 ) ; to receive 3 pairs of therapeutic shoes and 3 pairs of prefabricated , tapered polyurethane inserts with a brushed nylon cover ( n = 119 ) ; or to wear their usual footwear ( controls ; n = 160 ) . MAIN OUTCOME MEASURE Foot reulceration , compared among the 3 groups . RESULTS Two-year cumulative reulceration incidence across the 3 groups was low : 15 % in the cork-insert group , 14 % in the prefabricated-insert group , and 17 % in controls . In the intent-to-treat analysis , patients assigned to therapeutic shoes did not have a significantly lower risk of reulceration compared with controls ( risk ratio [ RR ] for the cork-insert group , 0.88 ; 95 % confidence interval [ CI ] , 0.51 - 1.52 and RR the for prefabricated-insert group , 0.85 ; 95 % CI , 0.48 - 1.48 ) . All ulcer episodes in patients assigned to therapeutic shoes and 88 % wearing non study shoes occurred in patients with foot insensitivity . CONCLUSIONS This study of persons without severe foot deformity does not provide evidence to support widespread dispensing of therapeutic shoes and inserts to diabetic patients with a history of foot ulcer . Study shoes and custom cork or preformed polyurethane inserts conferred no significant ulcer reduction compared with control footwear . This study suggests that careful attention to foot care by health care professionals may be more important than therapeutic footwear but does not negate the possibility that special footwear is beneficial in persons with diabetes who do not receive such close attention to foot care by their health care providers or in individuals with severe foot deformities For patients with diabetes mellitus and diabetic foot syndrome  customized orthopedic shoes represent the most effective treatment to avoid foot ulceration and amputation .  A total of 53 patients suffering from diabetes and treated with customized orthopedic shoes for more than 5 years were included in the study . Of the patients 91 % had peripheral artery occlusion disease , polyneuropathy and diabetic neuropathic osteoarthropathy ( DNOAP ) and in nearly 25 % amputation of one limb had already been carried out . The incidence of ulcers over a time period of 5 years was assessed from the patient records and question ing the patients . Questions on the duration of wearing orthopedic shoes , the durability of the shoes and result ing pain were also included . All patients except for one had problems walking on uneven surfaces . Of the patients 89 % cl aim ed to have used their shoes always or nearly always and 25 % of the shoes had to be replaced after 1 year . The incidence of ulcers was 38 % after 5 years . Treatment with customized orthopedic shoes is an effective method to prevent ulcers and amputation . To be successful it is necessary to control that the shoes are made correctly . Not all shoes last as long as 2 years OBJECTIVE To evaluate the efficacy of manufactured shoes specially design ed for diabetic patients ( Podiabetes by Buratto Italy ) to prevent relapses of foot ulcerations . RESEARCH DESIGN AND METHODS A prospect i ve multicenter r and omized follow-up study of patients with previous foot ulcerations was conducted . Patients were alternatively assigned to wear either their own shoes ( control group , C ; n = 36 ) or therapeutic shoes ( Podiabetes group , P ; n = 33 ) . The number of ulcer relapses was recorded during 1-year follow-up . RESULTS Both C and P groups had similar risk factors for foot ulceration ( i.e. , previous foot ulceration , mean vibratory perception threshold > 25 mV ) . After 1 year , the foot ulcer relapses were significantly lower in P than in C ( 27.7 vs. 58.3 % ; P = 0.009 ; odds ratio 0.26 [ 0.2–1.54 ] ) . In a multiple regression analysis , the use of therapeutic shoes was negatively associated with foot ulcer relapses ( coefficient of variation = −0.315 ; 95 % confidence interval = −0.54 to −0.08 ; P = 0.009 ) . CONCLUSIONS The use of specially design ed shoes is effective in preventing relapses in diabetic patients with previous ulceration BACKGROUND Insoles are regarded as an appropriate tool for the management of rheumatic foot disorders . However , a quality control for this purpose has not been established . In our study , the clinical effectiveness of insoles used in patients with rheumatic foot disorders was addressed . In addition , we sought to establish pedobarography as a means of quality control for orthotic management of the rheumatic foot . MATERIAL AND METHODS Our study included 20 rheumatoid arthritis patients with painful rheumatic foot deformities who were provided with insoles .  Clinical data were obtained by physical examination and a 100-mm pain scale . Pedobarography was performed using the novel pedar cable system with new and individually design ed insoles and after a 6-month follow-up . A shoe-only trial served as control . The parameters maximum force , peak pressure , force-time integral , and average pressure were analyzed in anatomical regions and an individually defined overloaded forefoot region . RESULTS Clinical improvement was significant after a 6-month follow-up in spite of a heterogeneous group of patients . However , our results could not confirm consistent changes in plantar pressure distribution . CONCLUSION As a conclusion , further efforts are necessary to establish a quality control for orthotic management of the rheumatic foot BACKGROUND The efficacy of custom-made shoes to prevent  diabetic foot ulcerations  is still unsatisfactory and specific conception is lacking . METHOD AND PATIENTS We conducted a prospect i ve study on 32 consecutive patients with diabetic mellitus , sensitive neuropathy and healed minor amputation of the foot . They were following a prevention program ( education , medical consultation every month ) . They were treated by custom-made shoes in order to obtain a tested and effective load-off area ( after trying and modifying a temporary footwear according to a simple qualitative test of the plantar pressure ) . RESULTS At 1 year , 9 % of patients presented a new foot ulceration and 3 % new minor amputations of the foot . The custom-made shoes had very thick multiple layer total-contact soles ( mean thickness 25 mm for a forefoot deformity and 40 mm for a mid-foot deformity ) . CONCLUSION This new concept of custom-made shoes might be effective in enhancing the prevention of neuropathic ulcerations for high-risk patients . A r and omized controlled trial would be needed to establish sound evidence supporting this new approach for therapeutic footwear Background Offloading plantar pressure is a key strategy for the prevention or healing of neuropathic plantar ulcers in diabetes .  Non-removable walking casts , such as total contact casts , are currently considered the gold-st and ard for offloading this type of wound . However , alternative methods for offloading that are more cost effective and easier to use are continually being sought . The aim of this study was to evaluate the capacity of the DH Pressure Relief Shoe ™ to offload high pressure areas under the neuropathic foot in diabetes . Methods A within-subjects , repeated measures design was used . Sixteen participants with diabetic peripheral neuropathy were recruited and three footwear conditions were evaluated in a r and omised order : a canvas shoe ( the control ) , the participants ’ own st and ard shoe , and the DH Pressure Relief Shoe ™ . The primary outcome was peak plantar pressure , measured using the pedar-X ® mobile in-shoe system between the three conditions . Results Data analysis was conducted on 14 out of the 16 participants because two participants could not complete data collection . The mean peak pressure values in kPa ( ±SD ) for each condition were : control shoe 315.9 ( ±140.7 ) , participants ’ st and ard shoe 273.0 ( ±127.1 ) and DH Pressure Relief Shoe ™ 155.4 ( ±89.9 ) . There was a statistically significant difference in peak plantar pressure between the DH Pressure Relief Shoe ™ compared to both the control shoe ( p = 0.002 ) and participants ’ st and ard shoe ( p = 0.001 ) . The DH Pressure Relief Shoe ™ decreased plantar pressures by 51 % compared to the control shoe and by 43 % compared to participants ’ st and ard shoe . Importantly , for a couple of study participants , the DH Pressure Relief Shoe ™ appeared unsuitable for day-to-day wearing . Conclusions The DH Pressure Relief Shoe ™ reduced plantar pressures more than the other two shoe conditions . The DH Pressure Relief Shoe ™ may be a useful alternative to current offloading modalities used in clinical management of diabetic foot ulceration . However , clinical trials are needed to test their effectiveness for ulcer healing and to ensure they are useable and safe for patients in everyday activities Background While minimalist running shoes may have an influence on running biomechanics and on the incidence of overuse injuries , the term " minimalist " is currently used without st and ardisation . The objectives of this study were to reach a consensus on a st and ard definition of minimalist running shoes , and to develop and vali date a rating scale that could be used to determine the degree of minimalism of running shoes , the Minimalist Index ( MI ) . Methods For this modified Delphi study , 42 experts from 11 countries completed four electronic question naires on an optimal definition of minimalist shoes and on elements to include within the MI . Once MI was developed following consensus , 85 participants subjectively ranked r and omly assigned footwear models from the most to the least minimalist and rated their degree of minimalism using visual analog scales ( VAS ) , before evaluating the same footwear models using MI . A sub sample of thirty participants reassessed the same shoes on another occasion . Construct validity and inter- and intra-rater reliability ( intraclass correlation coefficients [ ICC ] ; Gwet 's AC1 ) of MI were evaluated . Results The following definition of minimalist shoes was agreed upon by 95 % of participants : " Footwear providing minimal interference with the natural movement of the foot due to its high flexibility , low heel to toe drop , weight and stack height , and the absence of motion control and stability devices " . Characteristics to be included in MI were weight , flexibility , heel to toe drop , stack height and motion control/stability devices , each subscale carrying equal weighing ( 20 % ) on final score . Total MI score was highly correlated with VAS ( r = 0.91 ) . A significant rank effect ( p < 0.001 ) confirmed the MI 's discriminative validity . Excellent intra- and inter-rater reliability was found for total MI score ( ICC = 0.84 - 0.99 ) and for weight , stack height , heel to toe drop and flexibility subscales ( AC1 = 0.82 - 0.99 ) , while good inter-rater reliability was found for technologies ( AC1 = 0.73 ) . Conclusion This st and ardised definition of minimalist shoes developed by an international panel of experts will improve future research on minimalist shoes and clinical recommendations . MI 's adequate validity and reliability will allow distinguishing running shoes based on their degree of minimalism , and may help to decrease injuries related to footwear transition The impact half‘of shoes ’ in the treatment of neuropathic forefoot ulcers was studied in two groups of diabetic patients , who were treated either by st and ard treatment alone ( retrospective controls , n = 22 ) , or by st and ard treatment plus‘half shoes ’ ( cases , n = 26 ) . The groups were matched for sex , age , type , and duration of diabetes and ulcer grading . The‘half‐shoe ’ cases ’ vs controls ’ median overall healing time was 70 vs 118 days , the median difference being 48 ( 95 % CI : −5 to 82 ) days ( NS ) . In the case group , hospitalization was required in 1/26 ( 4 % ) of patients , vs 9/22 ( 41 % ) of the control patients ( chi‐square , p < 0.01 ) . The home nursing service was required in 23 % of the cases vs 18 % of the controls ( NS ) . It is concluded that the use of half‐shoes , in conjunction with st and ard treatment provided by a specialized diabetic foot clinic , may reduce the overall healing time and does reduce the hospitalization rate . This has implication s for a rational strategy of treating unilateral diabetic neuropathic foot ulcers AIMS Diabetic patients with podopathy ( diabetic foot syndrome ) may need protective footwear , be it customized or industrially produced stock ' diabetic ' shoes ( SDS ) . The effectiveness of each type of ' diabetic ' shoe needs to be proven clinical ly , e.g. in terms of prevention of foot ulceration . The following study assesses a new German SDS , the LucRo shoe , which consists of rocker-shaped walking sole , a st and ardized shock absorption insole , and soft uppers without stiff toe-caps . The LucRo SDS has been registered as a Medicinal Product according to the European Community Guideline 93/42/EC . PATIENTS AND METHODS A total of 92 high-risk diabetic patients ( mean age 63 years , duration of diabetes 13 years ) with healed foot ulcer were recruited prospect ively over 31 months ; 87 patients suffered from polyneuropathy , 24 patients had peripheral ischaemic vessel disease . One group of patients ( n = 60 ) received the LucRo SDS and wore them , while the remaining patients ( n = 32 ) did not receive the SDS and were forced to use their normal footwear . This allocation reflects the haphazard reimbursement policies of the individual patients ' health insurance , and is in accordance with the current German legislation . The patients were followed up for up to 42 months until the first foot ulcer relapse , or the end of the study . RESULTS There were no differences between the groups concerning age , sex , type and duration of diabetes , prevalence of polyneuropathy and peripheral ischaemic vessel disease , frequency of foot care and mortality rate . The first year annual rate of foot ulcer relapse was significantly different between the groups : 60 % without SDS vs. 15 % with SDS . The overall cumulative ulcer-free survival was significantly greater with SDS ( P < 0.0001 , log rank test ) . CONCLUSION The LucRo stock ' diabetic ' shoe appears effective in the prevention of foot re-ulceration in high-risk patients with diabetic podopathy OBJECTIVE To investigate the influence of a custom foot orthotic intervention on the lower extremity dynamics in healthy runners . DESIGN Three-dimensional kinematics and kinetics were collected on 15 female runners ( > 15 miles per week ) while each performed the over-ground running trials in either a shoe only or a shoe+custom foot orthotic condition . Kinematic and kinetic variables were analyzed using Paired Sample t-tests . BACKGROUND Custom foot orthotics are frequently prescribed treatment modality for the management of overuse running injuries . Although it is generally accepted that a custom foot orthotic intervention produces positive clinical outcomes , it remains unclear what influence this therapeutic modality has on the dynamics of the lower extremity . METHODS Each subject performed five acceptable over-ground running trials ( 3.6 m s(-1 ) + /-5 % ) with and without the custom foot orthotic intervention in a running shoe . Selected maximum ankle and knee joint angles and moments were measured during the stance phase . RESULTS While wearing the custom foot orthotic , subjects exhibited significantly decreased maximum values in rearfoot eversion angle , rearfoot eversion velocity and internal ankle inversion moment . CONCLUSIONS In this sample of healthy female runners , the custom foot orthotic intervention led to significant decreases in maximum values for ankle dynamics in the frontal plane and in the sagittal plane of the knee joint . Relevance It remains unclear how a custom foot orthotic intervention influences lower extremity dynamics to produce positive clinical outcomes . Furthering our underst and ing of the dynamic influence will not only inform improved prescription and manufacturing practice s but may provide insight into the mechanisms that cause overuse injuries OBJECTIVE To conduct a prospect i ve evaluation of footwear characteristics as predictors of diabetic foot wounds . RESEARCH DESIGN AND METHODS A total of 352 patients with NIDDM enrolled in a r and omized controlled trial aim ed at preventing diabetic foot lesions in an academic general medicine practice were studied .  Foot wounds ( n = 63 ) were modeled univariately and multivariably using generalized estimating equations . The dependent variable was a wound classified as a 1.2 or greater according to the Seattle Wound Classification System , indicating at least a superficial or healing minor lesion with no functional interruption of the protective cutaneous barrier . Independent variables included detailed measures of style and material of patients ' indoor and outdoor shoes , appropriate length and width , sock fibers , whether the patient had bought new shoes in the past 6 months , and if the patient had been recommended for special shoes . Modeling controlled for intervention status and physiological measures ( baseline wound , monofilament abnormalities , and serum HDL level ) . RESULTS Initial screening ( P < 0.20 ) suggested that a recommendation for special shoes , shoe length , and shoe width were indicative of wounds at follow-up ( odds ratios [ ORs ] 2.19 , 1.84 , 1.86 , respectively ) , while having bought shoes in the past 6 months was associated with no wound at follow-up ( OR 0.60 ) . The final multivariable model included only the recommendation for special shoes ( OR 2.19 ; 95 % CI 1.07–4.49 ) . CONCLUSIONS Many variables commonly cited as protective measures in footwear for diabetic patients were not prospect ively predictive when controlling for physiological risk factors . Rigorous analyses are needed to examine the many assumptions regarding footwear recommendations for diabetic patients Background : Ankle – foot orthoses could be utilized both with and without shoes . While several studies have shown that ankle – foot orthoses improve gait abilities in hemiplegic patients , it remains unclear whether they should be used with shoes or without . Objectives : The study purpose was to compare the effect of st and ard shoes and rocker shoes on functional mobility in post-stroke hemiplegic patients utilizing ankle – foot orthosis .  Study design : R and omized clinical study . Methods : Thirty post-stroke hemiplegic patients participated in this study r and omly assigned to two groups . Group I received st and ard shoes + ankle – foot orthosis and group II were provided with rocker shoes + ankle – foot orthosis . Their functional mobility and energy expenditure parameters including timed up and go , timed up stairs , timed down stairs , preferred walking speed , and oxygen ( O2 ) cost ( mL/kg/m ) were measured . Results : In group I , no significant changes were seen in outcome measures after wearing st and ard shoes . While in group II , O2 cost and timed up and go time significantly decreased , and preferred walking speed increased when patients wore rocker shoes . Also , there was a significant difference between rocker shoes and st and ard shoes in improvement of timed up and go , preferred walking speed , and O2 cost . Conclusion : When patients using ankle – foot orthosis wore rocker shoes , their functional mobility improved and oxygen cost diminished . Also , rocker shoes was significantly more effective than st and ard shoes in improving functional mobility parameters . Clinical relevance This study suggests that in post-stroke hemiplegic patients using ankle – foot orthosis , wearing rocker shoes can lead to much more improved functional mobility and decreased energy expenditure compared to ankle – foot orthosis only . Thus , in stroke patients , the combination of ankle – foot orthosis-rocker shoes is recommended for both rehabilitation programs and ankle – foot orthosis efficacy investigations OBJECTIVE To compare the effectiveness of total-contact casts ( TCCs ) , removable cast walkers ( RCWs ) , and half-shoes to heal  neuropathic foot ulcerations in individuals with diabetes . RESEARCH DESIGN AND METHODS In this prospect i ve clinical trial , 63 patients with superficial noninfected , nonischemic diabetic plantar foot ulcers were r and omized to one of three off-loading modalities : TCC , half-shoe , or RCW . Outcomes were assessed at wound healing or at 12 weeks , whichever came first . Primary outcome measures included proportion of complete wound healing at 12 weeks and activity ( defined as steps per day ) . RESULTS The proportions of healing for patients treated with TCC , RCW , and half-shoe were 89.5 , 65.0 , and 58.3 % , respectively . A significantly higher proportion of patients were healed by 12 weeks in the TCC group when compared with the two other modalities ( 89.5 vs. 61.4 % , P = 0.026 , odds ratio 5.4 , 95 % CI 1.1 - 26.1 ) . There was also a significant difference in survival distribution ( time to healing ) between patients treated with a TCC and both an RCW ( P = 0.033 ) and half-shoe ( P = 0.012 ) . Patients were significantly less active in the TCC ( 600.1 + /- 320.0 daily steps ) compared with the half-shoe ( 1,461.8 + /- 1,452.3 daily steps , P = 0.04 ) . There was no significant difference in the average number of steps between the TCC and the RCW ( 767.6 + /- 563.3 daily steps , P = 0.67 ) or the RCW and the half-shoe ( P = 0.15 ) . CONCLUSIONS The TCC seems to heal a higher proportion of wounds in a shorter amount of time than two other widely used off-loading modalities , the RCW and the half-shoe OBJECTIVE To determine whether shoe characteristics affect balance in older women . DESIGN R and omized order , cross-over , controlled comparison . SETTING A retirement village . PARTICIPANTS Thirty women aged 60 to 89 years ( mean 78.7 SD = 8.5 ) . Twenty-five subjects were hostel residents , and five were living independently in the community . OUTCOME MEASURES Postural sway , maximal balance range , and co-ordinated stability . MAIN RESULTS The subjects underwent assessment s of static balance ( body sway ) and dynamic balance ( maximal balance range and co-ordinated stability ) under four conditions : ( 1 ) barefoot , ( 2 ) in st and ard low-heeled shoes ( walking shoes ) , ( 3 ) in st and ard high-heeled shoes , and ( 4 ) in their own shoes . Manova analysis revealed a significant overall shoe condition effect -- subjects performed best in bare feet or low-heeled shoes and worst in high-heeled shoes . There were no significant differences between subjects with and without foot abnormalities in any of the balance measures or test conditions . CONCLUSION These findings suggest that bare feet and walking shoes maximize balance , whereas high-heeled shoes constitute a needless balance hazard for older women Background The present study examines the injury status in women runners who are r and omised to receive a neutral , stability or motion control running shoe .  Methods 81 female runners were categorised into three different foot posture types ( 39 neutral , 30 pronated , 12 highly pronated ) and r and omly assigned a neutral , stability or motion control running shoe .  Runners underwent baseline testing to record training history , as well as leg alignment , before commencing a 13-week half marathon training programme . Outcome measures included number of missed training days due to pain and three visual analogue scale ( VAS ) items for pain during rest , activities of daily living and with running . Results 194 missed training days were reported by 32 % of the running population with the stability shoe reporting the fewest missed days ( 51 ) and the motion control shoe ( 79 ) the most . There was a significant main effect ( p<0.001 ) for footwear condition in both the neutral and pronated foot types : the motion control shoe reporting greater levels of pain in all three VAS items . In neutral feet , the neutral shoe reported greater values of pain while running than the stability shoe ; in pronated feet , the stability shoe reported greater values of pain while running than the neutral shoe . No significant effects were reported for the highly pronated foot , although this was limited by an inadequate sample size . Conclusion The findings of this study suggest that our current approach of prescribing in-shoe pronation control systems on the basis of foot type is overly simplistic and potentially injurious PURPOSE The purpose s of this study were ( a ) to determine lower extremity anthropometric and sensory factors that are related to differences in comfort perception of shoe inserts with varying shape and material and ( b ) to investigate whether shoe inserts that improve comfort decrease injury frequency in a military population . METHODS 206 military personnel volunteered for this study . The shoe inserts varied in arch and heel cup shape , hardness , and elasticity in the heel and forefoot regions . A no insert condition was included as the control condition . Measured subject characteristics included foot shape , foot and leg alignment , and tactile and vibration sensitivity of the plantar surface of the foot . Footwear comfort was assessed using a visual analog scale . Injury frequency was evaluated with a question naire . The statistical analyses included Student 's t-tests for repeated measures , ANOVA ( within subjects ) , MANOVA ( within insert combinations ) , and chi-square tests . RESULTS The average comfort ratings for all shoe inserts were significantly higher than the average comfort rating for the control condition . The incidence of stress fractures and pain at different locations was reduced by 1.5 - 13.4 % for the insert compared with the control group . Foot arch height , foot and leg alignment , and foot sensitivity were significantly related to differences in comfort ratings for the hard/soft , the viscous/elastic , and the high arch/low arch insert combinations . CONCLUSIONS Shoe inserts of different shape and material that are comfortable are able to decrease injury frequency . The results of this study showed that subject specific characteristics influence comfort perception of shoe inserts Objective . The objective of this study was to assess the impact of a structured follow-up program on the incidence of diabetic foot ulceration ( DFU ) in high-risk diabetic patients . Research Design and Methods . A total of 1874 diabetic patients referred to the Diabetic Foot Unit of the University of Pisa were ranked based on the ulcerative risk score proposed by the International Consensus on Diabetic Foot . Out of 334 patients ( 17.8 % ) with a score ≥2 , 298 accepted to participate in this prospect i ve trial and were r and omized into 2 groups : group A , which received st and ard treatment , and group B , in which the patients received , as a part of a structured prevention program , custom-made orthesis and shoes .  Incidence of new DFUs was observed for no less than 1 year and in a subset of patients after 3 and 5 years , respectively . Incidence of new DFUs and recurrences were considered as primary endpoints to establish the effectiveness of the program ; costs were also compared . Results . Among the patients enrolled in this follow-up analysis , 46 % had neuropathy and deformities , 20 % had previous ulceration , 25 % had previous minor amputation , and 9 % had neuro-osteoarthropathy . During the first 12-month follow-up , 11.5 % of patients in group B developed a DFU compared with 38.6 % in group A ( P < .0001 ) . In the extended follow-up , the cumulative incidence of ulcer in group B compared with group A was 17.6 % versus 61 % ( P < .0001 ) after 3 years and 23.5 % versus 72 % ( P < .0001 ) after 5 years , respectively . The net balance at the end of the follow-up was highly in favor of the prevention program , with a saving of more than € 100 000 per year . Conclusions . The implementation of a structured follow-up with the use of orthesis and shoes can reduce the incidence of DFU  in diabetic patients who are at high ulcerative risk and its related costs Fifteen centers for orthopaedic treatment of the foot and ankle participated in a prospect i ve r and omized trial to compare several nonoperative treatments for proximal plantar fasciitis ( heel pain syndrome ) . Included were 236 patients ( 160 women and 76 men ) who were 16 years of age or older . Most reported duration of symptoms of 6 months or less . Patients with systemic disease , significant musculoskeletal complaints , sciatica , or local nerve entrapment were excluded . We r and omized patients prospect ively into five different treatment groups . All groups performed Achilles tendon- and plantar fascia-stretching in a similar manner . One group was treated with stretching only . The other four groups stretched and used one of four different shoe inserts , including a silicone heel pad , a felt pad , a rubber heel cup , or a custom-made polypropylene orthotic device . Patients were reevaluated after 8 weeks of treatment . The percentages improved in each group were : ( 1 ) silicone insert , 95 % ; ( 2 ) rubber insert , 88 % ; ( 3 ) felt insert , 81 % ; (4)stretching only , 72 % ; and ( 5 ) custom orthosis , 68 % . Combining all the patients who used a prefabricated insert , we found that their improvement rates were higher than those assigned to stretching only ( P = 0.022 ) and those who stretched and used a custom orthosis ( P = 0.0074 ) . We conclude that , when used in conjunction with a stretching program , a prefabricated shoe insert is more likely to produce improvement in symp-toms as part of the initial treatment of proximal plantar fasciitis than a custom polypropylene orthotic device Background Special insoles and shoes design ed to prevent foot ulcers caused by repetitive high pressures are recommended for patients with diabetes who have any of the following risk factors : neuropathy ; peripheral vascular disease ; foot deformities ; previous ulcers ; amputation ; and skin pathologies . However , there is a need for increased knowledge regarding : a ) differences in the peak pressure ( PP ) and pressure time integral ( PTI ) for different types of insoles ; and b ) the properties of the pressure distribution for insoles used over a period of several months . We present the results of a r and omized trial to compare the plantar pressures of three commonly used insoles . Objectives The primary objective was to compare the PP and PTI between three types of insoles . The secondary objective was to explore the long-term pattern of peak plantar pressure distribution and variations in specific regions of interest ( ROI ) . The tertiary objective was to investigate the impacts of insole adjustments , how much the insoles were used , and the levels of patient satisfaction . Methods In a 2-year trial , 114 patients with type 1 ( N = 31 ) or type 2 ( N = 83 ) diabetes ( 62 men and 52 women ; mean age , 57.7 ± 15.4 years ; duration of diabetes , 12.3 ± 11.2 years ; neuropathy , 38 % ) , were r and omized to be supplied with one of three different insoles . The ethylene vinyl acetate ( EVA ) insoles were used in outdoor walking shoes . The 35 EVA group ( N = 39 ) received soft custom-made insoles composed of EVA of 35 shore A hardness , the 55 EVA group ( N = 37 ) received custom-made insoles composed of EVA of 55 shore hardness , and the control group ( N = 38 ) received prefabricated insoles composed of a hard core with a top layer of soft 12 shore hardness microfiber . Using F-Scan ® , the in-shoe plantar pressures were measured at seven ROI ( hallux , metatarsal head 1 , metatarsal head 2 , metatarsal head 4 , metatarsal head 5 , lateral aspect of the mid-foot , heel ) on five occasions during the study period . The plantar-pressure variables used were PP ( main outcome ) and PTI . The plantar patterns of load were explored , satisfaction and usage of the insoles were rated by the participants , and insole adjustments were recorded . Results A mixed model analysis estimated lower PP values in the heel regions for the 35 EVA and 55 EVA insoles ( 171 ± 13 and 161 ± 13 kPa , respectively ) than for the prefabricated insoles ( 234 ± 10 kPa ) ( p < 0.001 ) . Also for some of the other six ROI indications of difference in PP or PTI could be observed . The redistribution of peak plantar pressure for all of the insoles , was stable at the mid-foot , while the proportion of load on the distal area changed during the study period According to the self-reported answers ( scale , 0–100 ) , the average usage of the insoles was rated as 79 and satisfaction was rated as 85 ( N = 75 ) . Thirty-two percent of the subjects had not received foot care . Fourteen adjustments to insoles were made during the study period , and 86 pairs of insoles were exchanged due to wear , with 49 % being exchanged in the 35 EVA group . Conclusions Custom-made insoles used in combination with stable walking shoes gave lower pressures at the heel region . The variation makes it difficult to detect a systematic difference in plantar pressure for the 6 ROI , if such a difference indeed exists . The levels of satisfaction and usage for all the insoles tested were high . The insoles maintained their pressure redistribution properties over long periods , and few adjustments were needed
The present review shows that current scientific literature concerning the usability of orthopaedic shoes focuses mainly on effectiveness at the expense of the other domains of usability , i.e. , efficiency , satisfaction and context of use
Objective : To determine the method ological quality of studies evaluating  orthopaedic shoes and orthopaedic shoe provisions .
To what extent do studies evaluating  orthopaedic shoes prescribed for patients with degenerative disorders of the foot , rheumatoid arthritis , diabetes mellitus and neurological foot disorders , focus on the aspects of the International Organization for St and ardization ( ISO ) definition of usability , i.e. , effectiveness , efficiency , satisfaction , and context of use ?