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Powered Foot Prosthesis and Physical Therapy for Lower Limb Problem
N/A
Recruiting
Led By Jason Maikos, PhD
Research Sponsored by VA New York Harbor Healthcare System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Able to walk on treadmill for 5 minutes at self-selected speed with or without use of handrails
Able to walk a minimum of 30 meters without an assistive device
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 4, and week 8
Awards & highlights
Study Summary
This trial will test whether an intensive, device-specific PT intervention can improve the function of powered ankle-foot prostheses for individuals with transfemoral amputation.
Who is the study for?
This trial is for adults with a single above-knee amputation who use a microprocessor knee, can walk at least 30 meters unaided, and haven't had much physical therapy recently. It's not for those with significant other health issues, pregnant women in their second trimester or beyond, people over 287 pounds, major upper limb amputees, or those using similar powered devices.Check my eligibility
What is being tested?
The study tests a powered ankle-foot prosthesis on individuals with transfemoral amputation. Participants are split into two groups: one receives the device plus intensive physical therapy (PT), while the other gets the device with standard practice without formal PT. Their walking ability and pain levels are measured before and after using the device.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants might experience discomfort from adjusting to the new prosthesis or during physical therapy sessions. There could also be skin irritation where the prosthesis fits onto their limb.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can walk on a treadmill for 5 minutes at my own pace, using handrails if needed.
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I can walk 30 meters by myself without help.
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I have had 8 or fewer physical therapy sessions for my amputation in the last 6 months.
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I am 18 years old or older.
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I have an amputation above the knee on one leg.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 4, and week 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 4, and week 8
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline in CNS Vital Signs at Week 8
Change from Baseline in COWAT at Week 4 and Week 8
Change from Baseline in Category Test at Week 4 and Week 8
+5 moreSecondary outcome measures
Change in Promis Pain Interference levels between PT and non-PT groups
Change in Prosthetic Evaluation Questionnaire (PEQ) scores between PT and non-PT groups
Change in Prosthetic Evaluation Questionnaire-Addendum (PEQ-A) 4 Week responses between PT and non-PT groups
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Powered device with physical therapyExperimental Treatment1 Intervention
Subjects will be fitted with a powered ankle-foot prosthesis (Ottobock emPOWER) and provided an intensive device-specific physical therapy (PT) intervention. The subjects will complete, on average, 8 PT training sessions lasting 30 - 45 minutes each. The subjects will also be provided with a home exercise program.
Group II: Powered device with standard of practiceActive Control1 Intervention
Subjects will be fitted with a powered ankle-foot prosthesis (Ottobock emPOWER) and provided the current standard of practice training for use of this powered prosthesis. The prosthetist will confirm a stable and comfortable alignment and educate the subject on proper home usage. Next, the subject will undergo a 45 - 60 minute training with a physical therapist that is characteristic of the current standard of practice.
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Who is running the clinical trial?
VA New York Harbor Healthcare SystemLead Sponsor
24 Previous Clinical Trials
14,424 Total Patients Enrolled
Walter Reed National Military Medical CenterFED
137 Previous Clinical Trials
34,467 Total Patients Enrolled
Jason Maikos, PhDPrincipal Investigator - Director, VISN 2 Gait and Motion Analysis Laboratory
VA New York Harbor Healthcare System
2 Previous Clinical Trials
121 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not use illegal opioids or misuse prescription drugs.I use or have used a powered ankle-foot prosthesis in the last 6 months.I weigh more than 287 pounds.I do not have major health issues that could affect my participation in the study.I have severe circulation issues, like blocked blood vessels or swelling in my legs.I can walk on a treadmill for 5 minutes at my own pace, using handrails if needed.My residual limb is too short for a prosthetic fitting.I can walk 30 meters by myself without help.I am mentally capable of participating in the study without limitations.I have had a major amputation of my upper limb.I have had 8 or fewer physical therapy sessions for my amputation in the last 6 months.I can walk with little to no help.I am 18 years old or older.Walking for 15 minutes is not safe for me due to my health condition.I have an amputation above the knee on one leg.I have used a microprocessor knee for over 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Powered device with standard of practice
- Group 2: Powered device with physical therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment still open for this research endeavor?
"According to clinicaltrials.gov, this trial is enrolling patients as of present. Its initial posting was on November 17th 2017 and the last time it was modified was April 25th 2022."
Answered by AI
What are the main aims of this research initiative?
"This trial, which will be evaluated over Baseline, Week 4, and Week 8 intervals, seeks to compare changes in gait between those who received physiotherapy (PT) treatment and those that did not. Secondary outcomes include comparison of Promis Pain Interference scores among participants from both groups as well as Quality of Life and Prosthetic Evaluation Questionnaire-Addendum (PEQ-A) responses over the same period."
Answered by AI
How many participants is this clinical trial currently enrolling?
"Affirmative, this clinical investigation is currently in recruitment mode. As per the information posted on clinicaltrials.gov, it was published on November 17th 2017 and most recently updated April 25th 2022. 30 participants across a single site are needed for enrolment into the trial."
Answered by AI
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