The Effect of AposTherapy on Pain and Function in Knee Osteoarthritis Population: A Randomized Controlled Trial
Phase: NA
Conditions: Knee Osteoarthritis, Knee Pain
Sponsor: Montefiore Medical Center

AposTherapy for Knee OA
Protocol ver. 1.6, 12/20/2016
1
The effect of AposTherapy on pain and function in Knee Osteoarthritis population. 
A randomized controlled trial
Clinical Study Protocol
Study Type:
Randomized controlled trial 
PI
Matthew N. Bartels, MD, MPH
Professor and Chairman of Rehabilitation Medicine
Albert Einstein College of Medicine
Chairman, Department of Rehabilitation Medicine
Montefiore Medical Center
 
Protocol Version and Date:
Version 1.6, 12.20.2016
 
IRB NUMBER: 2015-4842
IRB APPROVAL DATE: 07/26/2018

AposTherapy for Knee OA
Protocol ver. 1.6, 12/20/2016
2
Study Synopsis
Title of the study
The effect of AposTherapy on pain and function in Knee 
Osteoarthritis (OA) population. A randomized controlled trial
Study objective
To evaluate the effect of AposTherapy on pain and function in 
knee OA population. 
Outcome 
measures
Primary outcome measures:

Pain and function at 1-year post treatment initiation
Secondary outcome measure:

Total healthcare utilization and costs of physical 
therapy and AposTherapy will be assessed, including 
physical therapy, ED visits, pharmacological pain 
treatments, injections, imaging studies, surgical 
procedures, physician visits related to knee pain and 
total physician visits

PROMIS Pain Interference and Physical Function 

Pain medication consumption

Quality of life

Gait assessment

6-min walk test

Blood pressure and resting heart rate

Adherence to treatment - AposTherapy (Patient to 
have step counter permanently attached to 
AposTherapy device, downloaded at each visit 

Overall activity and sleep patterns, both groups. Will 
be measured via FitBit Charge HR 
IRB NUMBER: 2015-4842
IRB APPROVAL DATE: 07/26/2018

AposTherapy for Knee OA
Protocol ver. 1.6, 12/20/2016
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(http://www.fitbit.com/chargehr#i.f9n1ye1ehxd30p) 
motion sensor worn for one week after each 
evaluation session, mailed back via prepaid mailer at 
the end of the week.
Study design
A randomized controlled trial (AposTherapy compared to 
traditional physical therapy)
STUDY 
POPULATION
Inclusion criteria
Patients suitable for inclusion in this study will be those fulfilling 
the following:

Patients suffering from symptomatic knee OA (uni/bi 
lateral) for at least six months, fulfilling the ACR clinical 
criteria for OA of the knee, and having radiographically 
assessed OA of the knee according to the Kellgren and 
Lawrence scale.

Patients with VAS pain score of ≥3cm (measured at 
baseline).

Males and females between the ages of 40-75.

17<BMI<40

Ambulatory and active patients that can participate in a 
rehabilitation program that includes daily walking

Stable medical regimen (no recent changes to their pain 
medication within a month) 

Able to walk at least 50 meters

Able to understand, read and sign the informed consent 
form

English or Spanish speaking
Exclusion 
Criteria
Patients with any of the following are to be excluded from the 
study:
IRB NUMBER: 2015-4842
IRB APPROVAL DATE: 07/26/2018

AposTherapy for Knee OA
Protocol ver. 1.6, 12/20/2016
4

Patients suffering from acute septic arthritis.

Patients suffering from inflammatory joint disease such as 
rheumatoid arthritis.

Patients who received a viscosupplementation 
/corticosteroid injection within 3 months of the study

Patients with diagnosis of avascular necrosis of the knee.

Patients with diagnosis of neuromuscular disease.

Patients with more than 3 falls in the last 12 months, OR 
any fall with an injury in the last 12 months. 

Patients exhibiting a lack of physical or mental ability to 
perform or comply with the study procedure.

Patients with a history of pathological osteoporotic 
fracture

Patients with referred pain in the knees from back or hip 
joint symptoms.

Patients with severe back pain, ≥ 4 cm in visual analogue 
scale or radiating leg pain

Patients with generalized body pain (both upper and 
lower extremities, such as fibromyalgia

No major surgery to the affected limb and contralateral 
limb (e.g. no joint replacements or surgical fracture 
repair)

No major cardiovascular comorbidities (able to enroll in 
an active exercise program)

Patient started on lipid lowering medication in last 3 
months 

Any change in blood pressure medications 

No recent physical therapy (no more recent than 6 
IRB NUMBER: 2015-4842
IRB APPROVAL DATE: 07/26/2018

AposTherapy for Knee OA
Protocol ver. 1.6, 12/20/2016
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months) on the affected limb

No active heart disease (ischemia or heart failure 
admissions within 6 months) and no active COPD 
(exacerbation within 6 months)

No active malignancies on ongoing treatment 

Patient with neurological gait pattern [2]

Patient requiring assistive device during gait analysis. 
Total number of 
patients
One-hundred and forty-seven (147) individuals will be randomly 
assigned to one of two groups; traditional physical therapy or 
AposTherapy on a 1:2 ratio (49:98). 
A sample size of 147 will yield 80% power to detect an expected 
difference on the WOMAC pain scale, with components 
measured on VAS scales from 0 to 10 and a summary score 
standardized to also range from 0 to 10, of 1.5 at a 2-sided alpha 
of 0.05. The difference corresponds to a clinically meaningful 
moderate effect size of 0.4 standard deviation units assuming a 
typical standard deviation of 2.65. Anticipating an attrition rate 
of 10%, we aim at recruiting 162 patients for the trial. 
Study groups
Patients will be randomly assigned to one of the following 
groups:

Patients with knee OA treated with AposTherapy

Patients with knee OA treated with traditional physical 
therapy 
Assessment time 
points
Patients will be enrolled in the study and have clinical 
evaluations at the following time points:

Pre-treatment

4 weeks following treatment initiation 
IRB NUMBER: 2015-4842
IRB APPROVAL DATE: 07/26/2018

AposTherapy for Knee OA
Protocol ver. 1.6, 12/20/2016
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
8 weeks following treatment initiation

12 weeks following treatment initiation

24 weeks following treatment initiation

52 weeks following treatment initiation 
IRB NUMBER: 2015-4842
IRB APPROVAL DATE: 07/26/2018

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Protocol ver. 1.6, 12/20/2016
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The effect of AposTherapy on pain and function in Knee Osteoarthritis (OA) population. A 
randomized controlled trial
1. Background
AposTherapy is a home-based exercise program utilizing footwear that causes exercise with 
normal daily activity that may significantly improve function in patients with knee pain in 
general, and specifically knee osteoarthritis (OA). Capitalizing on the reported excellent 
adherence and clinical benefit of Apos Therapy in patients with significant lower limb arthritis, 
we propose to evaluate this as a conservative treatment that may supplant/supplement 
traditional pain medications and physical therapy in knee OA population. [3-6]
A potential use of AposTherapy as a replacement for traditional physical therapy may yield a 
less costly, more effective therapy with better adherence. Problems with traditional therapy 
include poor patient adherence (patients often do not complete the sessions and have very 
poor adherence (about 50-60%) to home therapy programs [7]), added cost of travel (which 
may be more than $100 per session for ambulette or access-a-ride for eligible patients), and the 
lack of continuation in an ongoing exercise program, leading to relapse and need for 
retreatment. Additionally, access to physical therapy is limited for many patients since there 
are not enough available outpatient therapy services to meet the needs of all patients. Finding 
an alternative exercise program that will increase adherence, decrease total therapy visits, and 
improve patient’s outcomes with decreased dependence on pain medications is a high priority 
from both patient care and cost management perspectives.
AposTherapy potentially overcomes many of these issues with improving/modifying abnormal 
biomechanics (therefore decreasing pain), and a home-based exercise program utilizing 
footwear that causes exercise with normal activity by promoting perturbation. This 
biomechanical approach may significantly reduce pain and improve function in patients with 
IRB NUMBER: 2015-4842
IRB APPROVAL DATE: 07/26/2018

AposTherapy for Knee OA
Protocol ver. 1.6, 12/20/2016
8
knee OA. Capitalizing on the reported excellent adherence and clinical benefit of AposTherapy 
in patients with significant knee OA, we propose to evaluate the biomechanical exercise 
(wearing an appropriately calibrated shoe at home for a prescribed amount of time each day) 
as a conservative treatment that may supplement or supplant traditional pain medications, 
interventional pain procedures and physical therapy in an at-risk urban inner city population 
with knee OA. 
2. Study objective
The purpose of the current study is to evaluate the effect of this home-based biomechanical 
device and treatment (AposTherapy) in knee OA population. This will be a randomized single 
blinded (evaluator) trial of conventional physical therapy versus AposTherapy in patients with 
knee OA treated for one year. 
In order to assess the efficacy of the intervention with AposTherapy on our patient population, 
a set of primary and secondary outcome measures will be defined:
3. Outcome measures
3.1. Primary outcome measures:

Pain and function at 1 year following treatment initiation
3.2. Secondary outcome measure:

Total healthcare utilization and costs of physical therapy and AposTherapy will be 
assessed, including physical therapy, ED visits, pharmacological pain treatments, 
joint injections, imaging studies, surgical procedures, physician visits related to knee 
pain and total physician visits

Pain medication consumption

Quality of life

Gait assessment

6-min walk test
IRB NUMBER: 2015-4842
IRB APPROVAL DATE: 07/26/2018

AposTherapy for Knee OA
Protocol ver. 1.6, 12/20/2016
9

Blood pressure and resting heart rate

Adherence to treatment - AposTherapy group (Patient to have step counter 
permanently attached to AposTherapy device)

Overall activity and sleep patterns, both groups. Will be measured via FitBit Charge 
HR (http://www.fitbit.com/chargehr#i.f9n1ye1ehxd30p) motion sensor worn for 
one week after each evaluation session, mailed back via prepaid mailer at the end of 
that week.
4. Materials and Methods
4.1. Trial Design
Single blinded (evaluator), single-center, randomized controlled trial. 
4.2. Recruitment
Recruitment will be at the Montefiore Medical Center Moses Campus with therapy 
being provided on site.
4.3. Randomization
Blocked randomization will be used to assign to their respective treatment arm. The 
assigning ratio will be one to two; The random method of selection will be through a 
computerized random number generator. The on-site coordinator will be responsible for 
entering and maintaining the subject randomization information.
4.4. Ethics approval
This study will start following the approval of the institutional review board.
All patients will be asked to read and sign an informed consent prior to their final 
recruitment to the study.
4.5. Population
IRB NUMBER: 2015-4842
IRB APPROVAL DATE: 07/26/2018

AposTherapy for Knee OA
Protocol ver. 1.6, 12/20/2016
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We will offer this option to patients at the general clinic sites, orthopedic clinics, and 
general medical and rehabilitation practices of the Montefiore Medical Group and 
Departments of Orthopedics and Rehabilitation Medicine Practices, who would normally be 
referred for physical therapy for their knee pain. 
Inclusion Criteria: 

Patients suffering from symptomatic knee OA (uni/bi lateral) for at least six months, 
fulfilling the ACR clinical criteria for OA of the knee, and having radiographically 
assessed OA of the knee according to the Kellgren and Lawrence scale.

Patients with VAS pain score of ≥3cm (measured at baseline).

Males and females between the ages of 40-75.

17<BMI<40

Ambulatory and active patients that can participate in a rehabilitation program that 
includes daily walking

Stable medical regimen (no recent pain medication changes within a month)

Able to walk at least 50 meters

Able to understand, read and sign the informed consent form

English or Spanish speaking
Exclusion Criteria: 

Patients suffering from acute septic arthritis.

Patients suffering from inflammatory joint disease such as rheumatoid arthritis.

Patients who received a viscosupplementation/corticosteroid injection within 3 months 
of the study. 

Patients with diagnosis of avascular necrosis of the knee.

Patients with diagnosis of neuromuscular disease.
IRB NUMBER: 2015-4842
IRB APPROVAL DATE: 07/26/2018

AposTherapy for Knee OA
Protocol ver. 1.6, 12/20/2016
11

Patients with more than 3 falls in the last 12 months, OR any fall with an injury in the 
last 12 months. 

Patients exhibiting a lack of physical or mental ability to perform or comply with the 
study procedure.

Patients with a history of pathological osteoporotic fracture

Patients with referred pain in the knees from back or hip joint symptoms.

Patients with severe back pain, ≥ 4 cm in visual analogue scale or radiating leg pain

Patients with generalized body pain (both upper and lower extremities, such as 
fibromyalgia

No major surgery to the affected limb and contralateral limb (e.g. no joint replacements 
or surgical fracture repair)

No major cardiovascular comorbidities (able to enroll in an active exercise program)

Patient started on lipid lowering medication in last 3 months 

Any change in blood pressure medications 

No recent physical therapy (no more recent than 6 months) on the affected limb

No active heart disease (ischemia or heart failure admissions within 6 months) and no 
active COPD (exacerbation within 6 months)

No active malignancies

Patient with neurological gait pattern [2]

Patient requiring assistive device for gait analysis 
4.6. Sample size
Our target recruitment is 147 individuals randomly assigned to one of two groups; 
traditional physical therapy or AposTherapy, on a 1:2 ratio. A sample size of 147 patients 
will yield 80% power to detect an expected difference on the WOMAC pain scale, with 
components measured on VAS scales from 0 to 10 and a summary score standardized to 
also range from 0 to 10, of 1.5 at a 2-sided alpha of 0.05. The difference corresponds to a 
IRB NUMBER: 2015-4842
IRB APPROVAL DATE: 07/26/2018

AposTherapy for Knee OA
Protocol ver. 1.6, 12/20/2016
12
clinically meaningful moderate effect size of 0.4 standard deviation units assuming a typical 
standard deviation of 2.65. Anticipating an attrition rate of 10%, we aim at recruiting 162 
patients for the trial (54 patients will be assigned to traditional physical therapy and 108 
patients will be assigned to AposTherapy)  
4.7. Treatment protocol
Group 1: AposTherapy
AposTherapy is a biomechanical therapy that has the ability to combine the two well-
established treatment strategies for knee OA: reducing loads from the affected joint by altering 
joint kinematics and training of the neuromuscular system by perturbation. The AposTherapy 
device is comprised of convex adjustable biomechanical elements (‘pertupods’) placed under 
the hind-foot and fore-foot regions of each foot. The elements are attached via a platform in 
the form of a shoe. This platform enables a trained physiotherapist to calibrate the 
biomechanical elements to a customized configuration for each patient (Figure 1). 
Figure 1. The biomechanical device 
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Protocol ver. 1.6, 12/20/2016
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The AposTherapy Device. (a) A biomechanical device comprising two individually calibrated 
elements and a foot-worn platform. The elements are attached to a platform under the hind-
foot and forefoot regions. (b)The biomechanical elements are available in different degrees of 
convexity and resilience. (c) The specially designed sole of the platform includes two mounting 
rails and a positioning matrix to enable flexible positioning of each biomechanical element. 
[Elbaz, 2014].
During the first assessment the biomechanical device (AposTherapy device) will be individually 
calibrated to each patient by a physiotherapist certified in AposTherapy treatment 
methodology. The principle of device calibration is to achieve minimal pain while walking. For 
example, in knee OA with medial compartment disease, the pod-element under the hindfoot is 
shifted laterally from the neutral position. This shifts the center of pressure (COP) in the foot 
laterally, thereby reducing the magnitude of the knee adduction moment acting on the knee 
joint. This is done until the patient reports minimal pain during initial contact. The forefoot pod-
element is shifted medially from the baseline position until the patient reports minimal pain 
during mid-stance to toe-off. Once the desired alignment is achieved, the patient should report 
immediate pain relief while walking. Following calibration patients will receive home-based 
exercise guidelines. During the first three weeks patients will be instructed to wear the 
calibrated biomechanical device for 30 minutes, while doing their daily activities (overall 
accumulating 10-15 minutes’ walk). Patients will be instructed to gradually increase their 
wearing time reaching 2 hours a day following 3 months of treatment. After three months, 
patients will be encouraged to add outdoor walking, starting with 10 minutes and reaching 30 
minutes a day. Patients will be asked to come back to follow-up meetings at the clinical center 
after 4 weeks, 8 weeks, 12 weeks, 24 weeks and 52 weeks. During these follow-up meetings 
patients will be re-assessed by the Apos therapist and, if needed, the biomechanical device will 
be re-calibrated.
Group 2: Traditional physiotherapy
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AposTherapy for Knee OA
Protocol ver. 1.6, 12/20/2016
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Physical therapy for knee osteoarthritis is provided at Department of Rehabilitation Medicine, 
Moses Division, three times a week for 4 to 8 weeks (up to 20 sessions) depending on the 
progression of the subject. Each session takes about 1 hour. Physical therapist will follow the 
standard of care protocol available at our institution with minor adjustment as needed 
(Appendix 1). 
Typical physical therapy regimen for knee OA includes strengthening, stretching exercise, 
therapeutic modality and education. 
4.8. Assessment time points
Visits for evaluation will be done in a blinded fashion with independent evaluators who will 
perform all follow-up evaluations. Patients will have all outcome measures on initial entry into 
the study (pre-treatment), at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 52 weeks after entry 
into the study. 
4.9. Outcome measures
Primary study outcome: 

Western Ontario and McMaster Universities (WOMAC) pain scale at one year. 

WOMAC function scale at one year
Secondary study outcome: at: Pre-treatment, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 52 weeks.

WOMAC pain and function subscale

PROMIS Pain Interference and Physical Function

Costs: Assessment of total utilization and cost from resource utilization monitored 
via the CMO

MOS item of the Short Form (SF)-36  

Spatio-temporal gait assessment including gait velocity, step length, single limb 
support and limb symmetry measured by Zeno Walkway ®

6-min walk test

Blood pressure and resting heart rate 
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Protocol ver. 1.6, 12/20/2016
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
Treatment adherence: Measured via attendance at sessions of therapy 
(conventional therapy), hours of use of AposTherapy (Patient to have step counter) 

Overall activity and sleep patterns (both arms (via FitBit Charge HR 
(http://www.fitbit.com/chargehr#i.f9n1ye1ehxd30p) motion sensor worn for one 
week after each evaluation session, mailed back via prepaid mailer at the end of the 
week.)
5. Statistical analysis
All demographic data will be reported as mean standard deviations and average.  Data from 
primary and secondary outcome measures will be checked for skewness using Fisher-
Pearson coefficient of skewness. ANOVA or Kuskal- Wallis test will be applied depending 
normality of data. All statistical analysis will be conducted using IBM SPSS Statistics Ver.24.
6. Benefits 

Participants will all have physical therapy for their knee 

AposTherapy involves fewer visits to the physical therapy center thus allowing 
individuals more time at home and lower transportation costs

AposTherapy is done at home and more convenient

AposTherapy will be provided for free for participants. 
7. Risks 

Muscle soreness associated with exercise

Minimal fall risk with use of new footwear device and exercise
8. Subject Reimbursement 
Participants will be reimbursed a total of $40 at each assessment point (pre-treatment, at 4 
weeks, 8 weeks, 12 weeks, 24 weeks and 52 weeks after entry into the study).  Participants will 
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AposTherapy for Knee OA
Protocol ver. 1.6, 12/20/2016
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receive $95 reimbursement for their time at the completion of the study after return of all 
devices and materials. This will apply to all arms of the study. 
Study schedule:
Study Periods
Screening
 
Visit
1
2
3
4
5
6
7
Time (week)
-2
0
4
8
12
24
52
Patient Information and 
Informed Consent
X
 
 
 
 
 
 
Demographics
X
 
 
 
 
 
 
Medical History
X
 
 
 
 
 
 
In- /Exclusion Criteria
X
 
 
 
 
 
 
Radiography
X
 
 
 
 
 
 
Randomization
X
 
 
 
 
 
 
Administer traditional 
physical therapy
Physical Therapy is administered according to 
the protocol for the duration of enrollment in 
the study
Administer Biomechanical 
Device 
 
X
 
 
 
 
 
Adjustment Biomechanical 
Device
 
 
X
X
X
X
 
VAS and ODI
 
X
X
X
X
X
X
Secondary outcome 
measures
 
X
X
X
X
X
X
Adverse Events
 
X
X
X
X
X
X
IRB NUMBER: 2015-4842
IRB APPROVAL DATE: 07/26/2018

AposTherapy for Knee OA
Protocol ver. 1.6, 12/20/2016
17
Resources
AposTherapy
Montefiore

Training for Montefiore PTs

Full-time Apos resource to manage 
program on-site at Montefiore

AposTherapy devices

Clinical Principle Investigator Lead 

Research staff – 2 coordinators

Data informatics, including patient 
population, demographics, historical 
costs, etc. 

Research infrastructure including IRB, 
recruitment, clinical expertise

Study materials

Step counter/Fitbit monitors
Staff
Salary - 
Rate/Hr
Fringe
FTE or 
Hours
Total Cost
 
 
 
 
 
Attending Physician Supervision
$165,000
30.5%
0.2
$43,065
Study coordinator
$0
0.0%
2
$0
These will be Everest individuals
 
Informatics costs
$75
 
100
$7,500
Biostatistical support
$150
 
100
$15,000
CMO staff support
$65,000
30.5%
0.5
$42,413
 
 
 
 
 
Total Staffing Cost
 
 
 
$107,978
 
 
Materials
Cost per Unit
# of 
Patients
Qty
Subject Costs
 
Step counters:
 
25% of Patients and 10% loss
$50
37
41
$2,050 
Fitbit HR Monitors:
 
25% of Patients
$150
37
41
$6,150 
Mailing to Recover ste 
counter/Fitbit:*
$10
37
 
$14,800
 
 
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Transportation costs:
$100
147
 
$14,700 
Subject Complete Reimbursement
$100
147
 
$14,700
Zeno Walkway
$20,000
 
1
$20,000 
 
 
Total Materials
 
 
 
$72,400 
 
 
Total cost of the study 
 
 
 
$180,378 
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Appendix 1. Brief description of the physical therapy intervention [8-13]
Physical Therapy 
Three times per week up to 20 sessions
Reassessment by physiatrist after 8 sessions
Mandatory interventions:
1. Aerobic exercise: up to 10 minutes erogometer cycle or walk on the 
treadmill with Borg scale of perceived exertion: fairly light to somewhat hard  
2. Strengthening: 3 sets of 10 repetitions of:
Knee extension; hip abduction, adduction, extension; knee flexion. 
Resistance adjusted using Theraband® as appropriate.
3. Stretching exercise: up to 10 minutes: 60 seconds passive stretch of:
Rectus femoris, iliopsoas, adductor muscle, ilioitibial band and hamstring 
muscle, gastrocnemius with subtalar neutral
4. Neuromuscular coordination control exercises: 3 sets of 2 minutes of 
(choose from): standing weight-shifting exercises; standing balance on 
uneven surfaces; balance (wobble) board, side-stepping, forward-backward 
and shuttle-walking drills; or stair walking
Non-mandatory interventions, prescribed as needed after mandatory exercise
Modality: transcutaneous electrical stimulation (100Hz, 50 µ secs) or 
ultrasound (1.5 W/cm2) on the knee for 10 minutes  
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Home exercise program:
Perform walking on comfortable walking speed for 10 minutes and following 
exercise on both legs for approximately 10-15 minutes at a time, five days a 
week
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References 
1.
Jones, K.R., et al., Determining mild, moderate, and severe pain equivalency across pain-
intensity tools in nursing home residents. J Rehabil Res Dev, 2007. 44(2): p. 305-14.
2.
Verghese, J., et al., Abnormality of gait as a predictor of non-Alzheimer's dementia. N 
Engl J Med, 2002. 347(22): p. 1761-8.
3.
Elbaz, A., et al., Patients with knee osteoarthritis demonstrate improved gait pattern and 
reduced pain following a non-invasive biomechanical therapy: a prospective multi-centre 
study on Singaporean population. J Orthop Surg Res, 2014. 9: p. 1.
4.
Haim, A., et al., The outcome of a novel biomechanical therapy for patients suffering 
from anterior knee pain. Knee, 2013. 20(6): p. 595-9.
5.
Drexler, M., et al., Effects of a customized biomechanical therapy on patients with 
medial compartment knee osteoarthritis. Ann Phys Rehabil Med, 2012. 55(4): p. 213-28.
6.
Segal, G., et al., A non-invasive biomechanical device and treatment for patients 
following total hip arthroplasty: results of a 6-month pilot investigation. J Orthop Surg 
Res, 2013. 8: p. 13.
7.
Forkan, R., et al., Exercise adherence following physical therapy intervention in older 
adults with impaired balance. Phys Ther, 2006. 86(3): p. 401-10.
8.
Sihvonen, R., et al., Arthroscopic partial meniscectomy versus sham surgery for a 
degenerative meniscal tear. N Engl J Med, 2013. 369(26): p. 2515-24.
9.
Abbott, J.H., et al., Manual therapy, exercise therapy, or both, in addition to usual care, 
for osteoarthritis of the hip or knee: a randomized controlled trial. 1: clinical 
effectiveness. Osteoarthritis Cartilage, 2013. 21(4): p. 525-34.
10.
Fitzgerald, G.K., et al., OARSI Clinical Trials Recommendations: Design and conduct of 
clinical trials of rehabilitation interventions for osteoarthritis. Osteoarthritis Cartilage, 
2015. 23(5): p. 803-814.
11.
Lim, B.W., et al., Does knee malalignment mediate the effects of quadriceps 
strengthening on knee adduction moment, pain, and function in medial knee 
osteoarthritis? A randomized controlled trial. Arthritis Rheum, 2008. 59(7): p. 943-51.
12.
Tanaka, R., et al., Efficacy of strengthening or aerobic exercise on pain relief in people 
with knee osteoarthritis: a systematic review and meta-analysis of randomized 
controlled trials. Clin Rehabil, 2013. 27(12): p. 1059-71.
13.
Skou, S.T., et al., The efficacy of 12 weeks non-surgical treatment for patients not eligible 
for total knee replacement: a randomized controlled trial with 1-year follow-up. 
Osteoarthritis Cartilage, 2015.
IRB NUMBER: 2015-4842
IRB APPROVAL DATE: 07/26/2018