Trial Outcomes & Findings for The Effect of AposTherapy on Knee Pain (NCT NCT03171168)
NCT ID: NCT03171168
Last Updated: 2022-12-14
Results Overview
Improvement in Pain and Function as assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scale. The WOMAC, a self-administered instrument, is 1 of 3 subscales comprising the WOMAC Index. As a standalone measure, the WOMAC pain scale contains 5 items that address the following person-level activities: walking, using stairs, in bed, sitting or lying down, and standing upright. The stem of the scale asks the patient to focus on the extent of pain experienced in the involved knee during each of these activities which are reported on a 0-4 Likert scale: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4), with a possible score range of 0-20 for Pain. Higher scores on the WOMAC are associated with worse knee pain.
TERMINATED
NA
54 participants
24 weeks
2022-12-14
Participant Flow
Participant milestones
| Measure |
Traditional Physical Therapy
Participants will have traditional physical therapy up to 20 sessions, up to two sessions per week. This will involve exercise and modalities as decided by the therapists and medical providers. Participants will have a home exercise program for the remainder of the year.
Traditional Physical Therapy: Up to 20 sessions of traditional physical therapy
|
AposTherapy
Participants will have AposTherapy instead of traditional physical therapy over the course of one year. This will include 7 sessions of gait assessment and re-calibration with daily at home exercise with the device over the year.
AposTherapy: 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).
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
37
|
|
Overall Study
COMPLETED
|
10
|
19
|
|
Overall Study
NOT COMPLETED
|
7
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of AposTherapy on Knee Pain
Baseline characteristics by cohort
| Measure |
Traditional Physical Therapy
n=17 Participants
Participants will have traditional physical therapy up to 20 sessions, up to two sessions per week. This will involve exercise and modalities as decided by the therapists and medical providers. Participants will have a home exercise program for the remainder of the year.
Traditional Physical Therapy: Up to 20 sessions of traditional physical therapy
|
AposTherapy
n=37 Participants
Participants will have AposTherapy instead of traditional physical therapy over the course of one year. This will include 7 sessions of gait assessment and re-calibration with daily at home exercise with the device over the year.
AposTherapy: 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).
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Continuous
|
59.24 years
n=5 Participants
|
61.83 years
n=7 Participants
|
61.01 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
37 participants
n=7 Participants
|
54 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: STUDY DISCONTINUED, statistical analysis was not performed due to study closure, not enough participants to conduct meaningful statistical analyses. The framework initially placed in the Statistical Analysis section has been removed. Analysis of individuals complete at 24 weeks. Only subjects with 24 week data were analyzed.
Improvement in Pain and Function as assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scale. The WOMAC, a self-administered instrument, is 1 of 3 subscales comprising the WOMAC Index. As a standalone measure, the WOMAC pain scale contains 5 items that address the following person-level activities: walking, using stairs, in bed, sitting or lying down, and standing upright. The stem of the scale asks the patient to focus on the extent of pain experienced in the involved knee during each of these activities which are reported on a 0-4 Likert scale: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4), with a possible score range of 0-20 for Pain. Higher scores on the WOMAC are associated with worse knee pain.
Outcome measures
| Measure |
Traditional Physical Therapy
n=8 Participants
Participants will have traditional physical therapy up to 20 sessions, up to two sessions per week. This will involve exercise and modalities as decided by the therapists and medical providers. Participants will have a home exercise program for the remainder of the year.
Traditional Physical Therapy: Up to 20 sessions of traditional physical therapy
|
AposTherapy
n=30 Participants
Participants will have AposTherapy instead of traditional physical therapy over the course of one year. This will include 7 sessions of gait assessment and re-calibration with daily at home exercise with the device over the year.
AposTherapy: 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).
|
|---|---|---|
|
Knee Pain and Function
|
5.1 units on a scale
Standard Deviation 2.8
|
3.2 units on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: STUDY DISCONTINUED, statistical analysis was not performed due to study closure, not enough participants to conduct meaningful statistical analyses. The framework initially placed in the Statistical Analysis section has been removed. Analysis of individuals complete at 24 weeks. Only subjects with 24 week data were analyzed
Health-related Quality of Life (QoL) as assessed using the RAND SF-36 (Short Form Health Survey). The RAND SF-36 is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Composite scoring range is 0 to 100 across the 8 domains identified with a higher overall score defining a more favorable health state.
Outcome measures
| Measure |
Traditional Physical Therapy
n=9 Participants
Participants will have traditional physical therapy up to 20 sessions, up to two sessions per week. This will involve exercise and modalities as decided by the therapists and medical providers. Participants will have a home exercise program for the remainder of the year.
Traditional Physical Therapy: Up to 20 sessions of traditional physical therapy
|
AposTherapy
n=30 Participants
Participants will have AposTherapy instead of traditional physical therapy over the course of one year. This will include 7 sessions of gait assessment and re-calibration with daily at home exercise with the device over the year.
AposTherapy: 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).
|
|---|---|---|
|
Quality of Life by RAND SF-36 (RAND Corporation Short Form 36)
|
48.8 score on a scale
Standard Deviation 13.06
|
64.34 score on a scale
Standard Deviation 16.0
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: STUDY DISCONTINUED, statistical analysis was not performed due to study closure, not enough participants to conduct meaningful statistical analyses. The framework initially placed in the Statistical Analysis section has been removed. Analysis of individuals complete at 24 weeks. Only subjects with 24 week data were analyzed.
Pain and Function measured through PROMIS short forms. PROMIS measures specific domains of Physical Health (e.g., physical function, pain intensity, pain interference, fatigue, sleep disturbance); Mental Health (depressive symptoms, anxiety, anger); and Social Health (ability to participate in social roles and activities). PROMIS measures are scored on the T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. PROMIS domains use different terms to describe score ranges. For example, some domains use mild/moderate/severe whereas others use very high to very low. Cut points for assessment can also vary. For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one SD above the average referenced population. This could be a desirable or undesirable outcome.
Outcome measures
| Measure |
Traditional Physical Therapy
n=8 Participants
Participants will have traditional physical therapy up to 20 sessions, up to two sessions per week. This will involve exercise and modalities as decided by the therapists and medical providers. Participants will have a home exercise program for the remainder of the year.
Traditional Physical Therapy: Up to 20 sessions of traditional physical therapy
|
AposTherapy
n=28 Participants
Participants will have AposTherapy instead of traditional physical therapy over the course of one year. This will include 7 sessions of gait assessment and re-calibration with daily at home exercise with the device over the year.
AposTherapy: 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).
|
|---|---|---|
|
PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference and Physical Function
|
20.7 T-score
Standard Deviation 33.9
|
19.1 T-score
Standard Deviation 41.9
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: STUDY DISCONTINUED, statistical analysis was not performed due to study closure, not enough participants to conduct meaningful statistical analyses. Data presented is for patients who completed 24 weeks of the study. Data reported is only on those who entered the study and not outcomes data. Cadence is in steps per minute as entered below. As an example, typical marching is at 120 steps per minute.
Objective assessment of the patients' gait assessed with gait analysis equipment. Equipment was used to measure the patients' cadence, or walking rate, in number of steps per minute (steps/min).
Outcome measures
| Measure |
Traditional Physical Therapy
n=12 Participants
Participants will have traditional physical therapy up to 20 sessions, up to two sessions per week. This will involve exercise and modalities as decided by the therapists and medical providers. Participants will have a home exercise program for the remainder of the year.
Traditional Physical Therapy: Up to 20 sessions of traditional physical therapy
|
AposTherapy
n=27 Participants
Participants will have AposTherapy instead of traditional physical therapy over the course of one year. This will include 7 sessions of gait assessment and re-calibration with daily at home exercise with the device over the year.
AposTherapy: 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).
|
|---|---|---|
|
Gait Assessment
|
93.7 Cadence (steps/minute)
Standard Deviation 20.1
|
109.7 Cadence (steps/minute)
Standard Deviation 18.3
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: STUDY DISCONTINUED, statistical analysis was not performed due to study closure, not enough participants to conduct meaningful statistical analyses.
objective assessment using maximum distance comfortably walked in 6 minutes on a 100 foot closed course
Outcome measures
| Measure |
Traditional Physical Therapy
n=12 Participants
Participants will have traditional physical therapy up to 20 sessions, up to two sessions per week. This will involve exercise and modalities as decided by the therapists and medical providers. Participants will have a home exercise program for the remainder of the year.
Traditional Physical Therapy: Up to 20 sessions of traditional physical therapy
|
AposTherapy
n=27 Participants
Participants will have AposTherapy instead of traditional physical therapy over the course of one year. This will include 7 sessions of gait assessment and re-calibration with daily at home exercise with the device over the year.
AposTherapy: 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).
|
|---|---|---|
|
6-min Walk Test
|
1292 Feet
Standard Deviation 229
|
1453 Feet
Standard Deviation 228
|
Adverse Events
Traditional Physical Therapy
AposTherapy
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Traditional Physical Therapy
n=17 participants at risk
Participants will have traditional physical therapy up to 20 sessions, up to two sessions per week. This will involve exercise and modalities as decided by the therapists and medical providers. Participants will have a home exercise program for the remainder of the year.
Traditional Physical Therapy: Up to 20 sessions of traditional physical therapy
|
AposTherapy
n=37 participants at risk
Participants will have AposTherapy instead of traditional physical therapy over the course of one year. This will include 7 sessions of gait assessment and re-calibration with daily at home exercise with the device over the year.
AposTherapy: 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).
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
5.9%
1/17 • Number of events 1 • 1 year
No active intervention, only follow-up
|
0.00%
0/37 • 1 year
No active intervention, only follow-up
|
|
Musculoskeletal and connective tissue disorders
Leg Pain
|
0.00%
0/17 • 1 year
No active intervention, only follow-up
|
2.7%
1/37 • Number of events 1 • 1 year
No active intervention, only follow-up
|
|
Nervous system disorders
Headache
|
0.00%
0/17 • 1 year
No active intervention, only follow-up
|
2.7%
1/37 • Number of events 1 • 1 year
No active intervention, only follow-up
|
|
Nervous system disorders
Back Pain
|
0.00%
0/17 • 1 year
No active intervention, only follow-up
|
2.7%
1/37 • Number of events 1 • 1 year
No active intervention, only follow-up
|
|
Musculoskeletal and connective tissue disorders
Inguinal hernia
|
0.00%
0/17 • 1 year
No active intervention, only follow-up
|
2.7%
1/37 • Number of events 1 • 1 year
No active intervention, only follow-up
|
|
Ear and labyrinth disorders
Earache
|
5.9%
1/17 • Number of events 1 • 1 year
No active intervention, only follow-up
|
0.00%
0/37 • 1 year
No active intervention, only follow-up
|
|
Blood and lymphatic system disorders
Hyperkalemia
|
0.00%
0/17 • 1 year
No active intervention, only follow-up
|
2.7%
1/37 • Number of events 1 • 1 year
No active intervention, only follow-up
|
|
Gastrointestinal disorders
Small Bowel Obstruction
|
5.9%
1/17 • Number of events 1 • 1 year
No active intervention, only follow-up
|
0.00%
0/37 • 1 year
No active intervention, only follow-up
|
|
Musculoskeletal and connective tissue disorders
Umbilical hernia
|
0.00%
0/17 • 1 year
No active intervention, only follow-up
|
2.7%
1/37 • Number of events 1 • 1 year
No active intervention, only follow-up
|
|
Musculoskeletal and connective tissue disorders
Cervical spondylosis
|
5.9%
1/17 • Number of events 1 • 1 year
No active intervention, only follow-up
|
0.00%
0/37 • 1 year
No active intervention, only follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/17 • 1 year
No active intervention, only follow-up
|
2.7%
1/37 • Number of events 1 • 1 year
No active intervention, only follow-up
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
5.9%
1/17 • Number of events 1 • 1 year
No active intervention, only follow-up
|
0.00%
0/37 • 1 year
No active intervention, only follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.00%
0/17 • 1 year
No active intervention, only follow-up
|
2.7%
1/37 • Number of events 1 • 1 year
No active intervention, only follow-up
|
|
Musculoskeletal and connective tissue disorders
Lower Extemity Weakness
|
0.00%
0/17 • 1 year
No active intervention, only follow-up
|
2.7%
1/37 • Number of events 1 • 1 year
No active intervention, only follow-up
|
|
Cardiac disorders
Hypertension
|
0.00%
0/17 • 1 year
No active intervention, only follow-up
|
2.7%
1/37 • Number of events 1 • 1 year
No active intervention, only follow-up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place