Clinical trial NCT05736016: Medial Wedge Insoles to Improve Gait in Persons After Total Hip Replacement
Official title: Influence of Medial Wedge Corrective Insoles Versus Sham Insoles on Gait Characteristics in Persons After Total Hip Replacement - Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Arthritis of Hip
Fracture of Femur
Aseptic Necrosis
Dysplasia; Hip
Surgical Procedure, Unspecified
Keywords: Total hip replacement
Gait
Insoles
Rehabilitation
Lead sponsor: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Sponsor class: NETWORK
First posted: 2023-02-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double-blind sham-controlled single-centre randomized study
Primary purpose: TREATMENT

Brief summary: The study will test the hypothesis, that the use of medial wedge insoles in people participating in comprehensive rehabilitation between 1-6 months after total hip replacement, and not having a varus deformity of the knee or symptomatic arthrosis of the medial knee compartment, will improve patient's functioning, the symmetry of gait and stance compared to persons using sham insoles.

The participants will undergo a 6-week program of in-patient rehabilitation aimed at: pharmacologic and non-pharmacologic pain management, improvement of vascular function, cardiopulmonary function, functions of skeletal muscles, range of motion and stability of peripheral joints, gait function, body position. The rehabilitation program will also address individual needs with psychotherapy and vocational therapy.

The study will help to identify correlations between gait parameter change and functional improvement during the rehabilitation following THR.

Study participants will be provided with individually made corrective medial wedge insoles or sham insoles and instructed to use them during gait training and everyday activities.

Functional parameters will be examined at the study entry, at the end of 6 weeks of intervention, and 6 weeks following discharge.

Detailed description: Principal indications for total hip replacement (THR) include hip arthritis - degenerative or inflammatory (91%), fractures of femoral neck (5%), avascular necrosis (2%) and hip dysplasia (2%). Weight-bearing exercises (including treadmill training) are important to improve both impairment and ability to function.

Rationale of testing the effect of medial wedge insoles after THR:

Valgus deformity of the lower limb and insufficiency of the gluteus medius muscle lead to femoral adduction. In patients after a total hip replacement (THR), it will transfer the ground force to the prosthesis cup in the adduction position.

The application of corrective insoles is a simple, inexpensive, and non-invasive intervention that may be easily integrated into daily activities to promote health benefits, provide comfort, and prevent acute and chronic injuries, as well as correct biomechanical deficiencies in the musculoskeletal system (including valgus knee ). An important effect of the insoles is to support the preferred movement pattern and, as a result, reduce unnecessary muscle activity in gait, and decrease fatigue and energy expenditure. The use of insoles can therefore be a valuable addition to gait function exercises. Typically, hindfoot corrective insoles are used with a wedge that corrects the heel between 5-15 degrees. Smaller correction wedge angles are unable to correct the valgus moment and affect the center of pressure (CoP) projection during walking, while wedges with a larger correction angle cause discomfort.\[5\] Medial wedge insoles increase heel inversion, reduce internal tibial rotation, transfer the CoP medially to the knee joint, and increase the knee and hip abduction moment.

Insufficiency of the gluteus medius muscle causing pelvic descent and internal rotation of the thigh is typical for hip arthritis, especially after THR using the posterior, posterolateral, or direct lateral approach. It was found that the use of medial wedge insoles promotes the activation of the gluteus medius during dynamic activities, although Bird et al. did not confirm this effect in people with low back pain.

Gait symmetry and voluntary walking speed belong to important gait quality parameters measured in patients after THR. Many variables illustrating gait symmetry such as ..step length, step time, time of load changes, foot rotation, time of gait phases, as well as temporal and spatial distribution of forces exerted by specific foot parts may be reliably measured with a treadmill instrumented with force sensors.

To identify publications on the effectiveness of corrective insoles after THR, an analysis of the Pubmed, Medline Central, and Scifinder literature databases was carried out using the key phrase: (("hip" AND ("replace\*" OR "plast\*" or "simple\*")) AND ( "insole\*" OR ("foot AND "correc\*"))) Identified (November 15, 2019) in databases; Medline Central: 20 records, Scifinder: 73 records, and Pubmed: 66 records. 159 records were reviewed in the title analysis stage, 9 records were eliminated as repeated, 150 records were eliminated as not related to the use of insoles after THR.

Evidence on the usefulness of supination insoles in people with arthritis of the lower limb, and also in people after hip arthroplasty is warranted.

Study design:

A single-center randomized control trial to observe the effect of medial wedge corrective insoles on gait characteristics in persons after THR will be performed in the Rehabilitation Department of the National Institute of Geriatrics, Rheumatology and Rehabilitation, Warsaw, Poland. The trial will involve 100 patients admitted 1-6 months after THR. Consecutive patients fulfilling inclusion criteria will be invited to participate. Participants will be randomly allocated in:

1. Intervention group: the patients will be provided with corrective medial wedge insoles (with hard 10-degree medial wedge)
2. Control group: the patients will be provided with sham medial wedge insoles (with pliable10 degree medial wedge)

Participants' age, sex, time since THR, cause of THR, body height and weight, Q angle, intermalleolar distance, and lower extremities length discrepancy will be measured at the study entry. All insoles will be fabricated individually. The design of insoles will comply with the participant's foot size and needs with regard to lower limb length discrepancy elimination. The participants will be recommended to use the insoles during all therapeutic activities and daily activities during the duration of the program. The participants will undergo a 6-week rehabilitation program provided in the Rehabilitation Department of the National Institute of Geriatrics, Rheumatology and Rehabilitation. The program will be aimed at: pharmacologic and non-pharmacologic pain management, improvement of vascular function, cardiopulmonary function, functions of skeletal muscles, range of motion and stability of peripheral joints, gait function, and body position. The rehabilitation program will also address individual needs with psychotherapy and vocational therapy. The following parameters will be assessed by a blinded researcher in the specific time points (1) 3rd day following delivery of insoles; (2) completion of the 6-week rehabilitation program; (3) follow-up 6 weeks after completion of the rehabilitation program:

Pain intensity (recently and on average during the preceding week), distress produced by pain (recently and on average during the preceding week), and interference of pain with everyday activities (Pain Rating Scale by the British Pain Society, the Polish version; © The British Pain Society 2006), passive ranges of motion of hip, knee, and ankle joints, pain, stiffness, and physical functional disability (Western Ontario and McMaster Universities - WOMAC scale), osteoarthritis-specific symptoms and physical functional disability (The Lequesne OA index), Gait variables: voluntary speed, step time symmetry, time of load change heel to forefoot symmetry, foot rotation symmetry, length symmetry, step width, stance phase symmetry, load response symmetry, single limb support symmetry, swing phase symmetry and variables illustrating the centre of pressure displacement (length of gait line symmetry, single limb support line symmetry, lateral deviation of the center of pressure, anteroposterior position of the center of pressure) (obtained by Zebris Medical Rehawalk software on HP Cosmos Mercury FDM-THP-M2i treadmill), Stance variables: Centre of Pressure path length, 95% confidence ellipse area, symmetry of average forces, Patient's satisfaction with insoles will be assessed at the completion of the study, Dropout rate and adverse effects.

Statistical analysis

Normally distributed data will be described by means and standard deviation and statistically tested using the Student t-test and ANOVA. Data not normally distributed will be described by medians and ranges and statistically tested using non-parametric methods such as Wilcoxon's test and the Kruskal-Wallis test. The frequency will be compared using Fisher's exact test. The normality of data will be tested using the Shapiro-Wilk test. The symmetry of gait and stance will be analyzed using different symmetry indices (such as Symmetry ratio, Symmetry index, Gait asymmetry, and Symmetry angle). The correlations between gait parameter change and functional improvement will be analyzed using Spearman's rank correlations coefficient and Fisher's exact test.

Significance of the results:

The evidence of the beneficial effect of medial wedge insoles on the functioning of patients after THR may result in a recommendation for the use of routine use of such devices after THR. The study will help to identify correlations between gait parameter change and functional improvement during the rehabilitation following THR.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of primary or secondary hip coxarthrosis or proxmal hip facture
* Total Hip replacement made from posterior or lateral surgical approaches
* Total Hip replacement made less 1-6 months prior to study entry

Exclusion Criteria:

* Total Hip replacement made from anterior or anterolateral approach
* Total Hip replacement made less than 1 month or more than 6 months prior to study entry
* Varus knee (Q angle below 5 degrees in males and below 10 degrees in females
* Symptomatic arthritis of medial compartment of the knee
* Use of corrective insoles (excluding insoles for limb length discrepancy compensation)
* Inability to walk for one minute
* Neurologic conditions
* History of hip prosthesis dislocation
* Cognitive dysfunction (MoCa Score below 26)
* Lack of shoes with a stiff heel counter

Primary outcomes:
measure: Mean change from baseline in pain according to Pain Rating Scale by the British Pain Society on numeric rating scales at 12 weeks
timeFrame: At baseline and on 12 week
measure: Mean change from baseline in pain, stiffness, and physical functional disability according to Western Ontario and McMaster Universities - WOMAC scale on 12 weeks
timeFrame: At baseline and on 12 week
measure: Mean change from baseline in osteoarthritis-specific symptoms and physical functional disability according to Lequesne OA index on 12 weeks
timeFrame: At baseline and on 12 week
Secondary outcomes:
measure: Mean change from baseline in range of motion of lower extremities on 6 weeks
timeFrame: At baseline and on 6 week
measure: Mean change from baseline in range of motion of lower extremities on 12 weeks
timeFrame: At baseline and on 12 week
measure: Mean change from baseline in voluntary gait speed on 6 weeks
timeFrame: At baseline and on 6 week
measure: Mean change from baseline in voluntary gait speed on 12 weeks
timeFrame: At baseline and on 12 week
measure: Mean change from baseline in step time symmetry on 6 weeks
timeFrame: At baseline and on 6 week
measure: Mean change from baseline in step time symmetry on 12 weeks
timeFrame: At baseline and on 12 week
measure: Mean change from baseline in time of load change heel to forefoot symmetry on 6 weeks
timeFrame: At baseline and on 6 week
measure: Mean change from baseline in time of load change heel to forefoot symmetry on 12 weeks
timeFrame: At baseline and on 12 week
measure: Mean change from baseline in time of maximum force exerted by forefoot symmetry on 6 weeks
timeFrame: At baseline and on 6 week
measure: Mean change from baseline in time of maximum force exerted by forefoot symmetry on 12 weeks
timeFrame: At baseline and on 12 week
measure: Mean change from baseline in time of maximum force exerted by midfoot symmetry on 6 weeks
timeFrame: At baseline and on 6 week
measure: Mean change from baseline in time of maximum force exerted by midfoot symmetry on 12 weeks
timeFrame: At baseline and on 12 week
measure: Mean change from baseline in time of maximum force exerted by heel symmetry on 6 weeks
timeFrame: At baseline and on 6 week
measure: Mean change from baseline in time of maximum force exerted by heel symmetry on 12 weeks
timeFrame: At baseline and on 12 week
measure: Mean change from baseline in foot rotation symmetry on 6 weeks
timeFrame: At baseline and on 6 week
measure: Mean change from baseline in foot rotation symmetry on 12 weeks
timeFrame: At baseline and on 12 week
measure: Mean change from baseline in step length symmetry on 6 weeks
timeFrame: At baseline and on 6 week
measure: Mean change from baseline in step length symmetry on 12 weeks
timeFrame: At baseline and on 12 week
measure: Mean change from baseline in step width on 6 weeks
timeFrame: At baseline and on 6 week
measure: Mean change from baseline in step width on 12 weeks
timeFrame: At baseline and on 12 week
measure: Mean change from baseline in the length of gait line marked out by the centre of pressure displacement on walking symmetry on 6 weeks
timeFrame: At baseline and on 6 week
measure: Mean change from baseline in the length of gait line marked out by the centre of pressure displacement on walking symmetry on 12 weeks
timeFrame: At baseline and on 12 week
measure: Mean change from baseline in the single limb support line marked out by the centre of pressure displacement on walking symmetry on 6 weeks
timeFrame: At baseline and on 6 week
measure: Mean change from baseline in the single limb support line marked out by the centre of pressure displacement on walking symmetry on 12 weeks
timeFrame: At baseline and on 12 week
measure: Mean change from baseline in lateral deviation of the center of pressure on 6 weeks
timeFrame: At baseline and on 6 week
measure: Mean change from baseline in lateral deviation of the center of pressure on 12 weeks
timeFrame: At baseline and on 12 week
measure: Mean change from baseline in anteroposterior deviation of the center of pressure on 6 weeks
timeFrame: At baseline and on 6 week
measure: Mean change from baseline in anteroposterior deviation of the center of pressure on 12 weeks
timeFrame: At baseline and on 12 week
measure: Mean change from baseline in Centre of Pressure path length in stance on 6 weeks
timeFrame: At baseline and on 6 week
measure: Mean change from baseline in Centre of Pressure path length in stance on 12 weeks
timeFrame: At baseline and on 12 week
measure: Mean change from baseline in 95% confidence ellipse area marked up by the Centre of Pressure displacement in stance on 6 weeks.
timeFrame: At baseline and on 6 week
measure: Mean change from baseline in 95% confidence ellipse area marked up by the Centre of Pressure displacement in stance on 12 weeks
timeFrame: At baseline and on 12 week
measure: Mean change from baseline in the ratio of average forces exerted by operated leg in comparison to non-operated leg during stance on 6 weeks
timeFrame: At baseline and on 6 week
measure: Mean change from baseline in the ratio of average forces exerted by operated leg in comparison to non-operated leg during stance on 12 weeks
timeFrame: At baseline and on 12 week
measure: User's satisfaction with insoles
timeFrame: On 12 week
measure: Mean change from baseline in pain according to Pain Rating Scale by the British Pain Society on numeric rating scales at 6 weeks
timeFrame: At baseline and on 6 week
measure: Mean change from baseline in pain, stiffness, and physical functional disability according to Western Ontario and McMaster Universities - WOMAC scale on 6 weeks
timeFrame: At baseline and on 6 week
measure: Mean change from baseline in osteoarthritis-specific symptoms and physical functional disability according to Lequesne OA index on 6 weeks
timeFrame: At baseline and on 6 week
Other outcomes:
Locations:
Study officials:
affiliation: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
name: Beata Tarnacka, MD PhD
role: STUDY_DIRECTOR
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