VA New York Harbor Healthcare System
New York, 10010, United States
NCT Number: NCT03625921
Individuals living with Transfemoral Amputation, enrolled equally at the Veterans Affairs New York Harbor Healthcare System (VANYHHS) and Walter Reed National Military Medical Center (WRNMMC), will be fit with a powered ankle-foot prosthesis. All subjects will undergo a full gait analysis, functional measures, neurocognitive/cognitive, and pain assessment at baseline utilizing their current passive prosthesis. Subjects will then be randomly assigned into 2 equal groups: Powered device with an 8-session intensive, device-specific PT intervention (Group A); or powered device with current standard of practice (Group B), with includes basic device education, but no PT intervention. Subjects in Group A will undergo a 4-week PT-based intervention, which will isolate the contribution of device specific effects from rehabilitation effects. Group B will receive the current standard of practice, which does not include any formal rehabilitation. All users will undergo a full gait analysis, functional measures, neurocognitive/cognitive, and pain assessment after 4- and 8-weeks of use.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Not applicable
New York, 10010, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will be fit with a powered prosthesis (Ottobock emPOWER) and enrolled in a device-specific physical therapy (PT) program.
Subjects will be fit with a powered prosthesis (Ottobock emPOWER) and enrolled in the current standard of practice training, which includes basic device education and prosthetic training.
Time frame: Baseline, Week 4, and Week 8
Biomechanical evaluation of gait with 3D motion capture while the individual is walking at several different speeds.
Time frame: Baseline, Week 4, and Week 8
The 6-minute walk test measures the distance an individual can walk in 6 minutes without help or encouragement.
Time frame: Baseline, Week 4, and Week 8
The AmpPro is a 21-item instrument designed to measure basic prosthetic mobility of individuals with lower extremity amputation.
Time frame: Baseline, Week 4, and Week 8
The Comprehensive High-Level Activity Mobility Predictor (CHAMP) is a 4-item, more advanced instrument to measure prosthetic mobility for individuals in this study that scored > 38 on the AmpPro
Time frame: Baseline, Week 4, and Week 8
Serial Subtraction is a cognitive test where participants are given a random 3 digit number and are asked to subtract by 3s while they walk for 1 minute on a treadmill at a comfortable walking speed. Total number of errors will be documented. Serial subtraction will be performed at baseline using their current prosthetic foot and again at 4- and 8-weeks utilizing the powered prosthesis.
Time frame: Baseline, Week 4, and Week 8
The Controlled Oral Word Association Test (COWAT) is a cognitive test where participants are asked to list as many words as they can think of beginning with a certain letter while walking for 1 minute on a treadmill at a comfortable speed. The participants will complete 3 rounds (3 letters). The total number of unique words for each letter will be documented. COWAT will be performed at baseline using their current prosthetic foot and again at 4- and 8- weeks utilizing the powered prosthesis.
Time frame: Baseline, Week 4, and Week 8
The Category Test is a cognitive test where participants are asked to list as many words as they can think of belonging to a certain category while walking for 1 minute on a treadmill at a comfortable speed. The total number of unique words for the category will be documented. The category test will be performed at baseline using their current prosthetic foot and again at 4- and 8- weeks utilizing the powered prosthesis.
Time frame: Baseline and Week 8
The CNS Vital Signs is a computerized neurocognitive assessment that assess 5 domains: memory, psychomotor speed, reaction time, complex attention, and cognitive flexibility. Participants will complete the online platform independently.
Time frame: Baseline, Week 4, and Week 8
The PEQ is a self-report Visual Analog Scale questionnaire for persons with lower limb amputations who use a prosthesis. It consists of 9 validated subscales. They are used to evaluate the prosthesis and life with the prosthesis. Most questions in the PEQ use a visual analog scale format. Each visual analog scale is scored as a continuous numerical variable measured as the distance in millimeters from the left endpoint of the line to the point at which the respondent's mark crosses the line. Each line is 100 mm long and is always measured from the left (0-100). The questions are all worded so that a higher number (toward the right) will correspond with a more positive response. Subscale scores are calculated by computing the average (arithmetic mean) of all the questions which make up that particular scale. Only subscales are calculated. A total combined score is not calculated.
Time frame: Baseline, Week 4, and Week 8
The Promis Pain Interference Scale is an 8-item self-report measure of pain interference over the last 7 days. There are 5 potential answers ranging from "not at all" to "very much" for participants to check off. Participants are only allowed to check off one answer per question.
Time frame: Baseline, Week 4, and Week 8
The Quality of Life Scale is a single item visual analog scale used to measure the participants' quality of life over the past four weeks or since their last visit. The visual analog scale is scored as a continuous numerical variable measured as the distance in millimeters from the left endpoint of the line to the point at which the respondent's mark crosses the line. The line is 100 mm long and is always measured from the left (0-100). On the left side of the scale (0 mm) it says "worst possible quality of life". On the right side of the scale (100 mm) it says "ideal quality of life, so the higher the score the more positive the response.
Time frame: Baseline, Week 4, and Week 8
The PEQ-A 4 Weeks is a free response 2-item questionnaire in which the participant is asked about any falls and/or stumbles over the last four weeks or since his or her last visit.
VA New York Harbor Healthcare System
Fed
Effects of a Powered Ankle-Foot Prosthesis and Device-Specific Physical Therapy on Function and Pain for Individuals Living With Transfemoral Limb Loss
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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