Bio Leg: Advancing Mobility (BAM)
Adaptive Mobility Technology: A Comparative Study of C-Leg and Bio Leg
연구 개요
상세 설명
Although microprocessor-controlled knees (MPKs) such as the C-Leg have demonstrated clear benefits over non-microprocessor-controlled prosthetic knees, it remains unclear whether powered knee assistance provides additional advantages in movement quality, metabolic efficiency, and limb loading during walking adaptability tasks.
This study directly addresses this gap by comparing mobility using the Bio Leg to mobility with the C-Leg using outcome measures that reflect real-world mobility challenges.
By generating objective evidence on whether powered knee assistance improves biomechanics, efficiency, and stability beyond that achieved with an established MPK, this study will inform prosthetic prescription, rehabilitation strategies, and payer decision-making. Given the growing population of individuals living with transfemoral amputation, identifying technologies that support safe, efficient, and confident mobility has important implications for community participation, long-term musculoskeletal health, and quality of life.
This study uses a within-subject repeated-measures design in which each participant is assessed under two conditions: current prosthesis and the Bio Leg prosthesis. All primary and secondary outcomes will be analyzed as within-participant differences, with each participant serving as their own control.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Emily J Fox, PT, DPT, MHS, PhD
- 전화번호: 904-742-2500
- 이메일: ejfox@phhp.ufl.edu
연구 연락처 백업
- 이름: Joshua C Encarnacion, BS
- 전화번호: 904-345-8969
- 이메일: Joshua.Encarnacion@brooksrehab.org
연구 장소
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Florida
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Jacksonville, Florida, 미국, 32216
- Brooks Rehabilitation
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adults 40 to 70 years of age
- Unilateral transfemoral amputation > 1 year
- K3 or K4 ambulator and able to walk with no greater assistances than a single point cane
- Current microprocessor-controlled prosthesis (C-leg) user with > 6 months experience and able to walk without a device of using a single point cane
- Able to give informed consent
Exclusion Criteria:
- Severe cardiovascular condition or other disease limiting study participation
- Skin lesions or wounds, acute or unstable fracture, diagnosis of osteoarthritis or bone impairments affecting safe participation in walking activities
- Residual limb dysfunction (i.e. joint contracture) limiting mobility or study participation
- Pain that limits walking of participation in walking activities
- Current participation in rehabilitation to address walking function
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: C-Leg
The first assessment will involve testing the participant with their current C-leg microprocessor prosthesis.
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실험적: Bio Leg
After the Bio Leg fitting, the participant will exclusively wear the Bio Leg knee component for an acclimation period that will be a minimum of 4 weeks and up to 6 depending on participant's schedule and comfort/ease of using the device.
Each participant will complete a minimum of 2 and up to 4 physical therapy sessions during the acclimation period.
These physical therapy sessions will involve standard physical therapy training for use of a prosthetic limb after amputation.
Following the acclimation period, the participant will complete the second assessment, which will mirror the first assessment.
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After completing biomechanics and clinical testing at Pre Assessment with their C-Leg, participants will be fitted with a Bio-Leg prosthesis at the prosthetist clinic.
The participant will train and use the Bio-Leg prosthesis during a 4-6 week acclimation period.
The participant will then complete the same biomechanics and clinical testing at Post Assessment.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in 6-Minute Walk Test (6MWT)
기간: Baseline, 4-6 weeks
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The distance that a patient should walk based on their height, weight, age, and gender.
Performance assessment of walking endurance for 6 minutes.
An increase in the number of meters walked during this assessment reflects an improvement in walking endurance.
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Baseline, 4-6 weeks
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Change in Interlimb Symmetry (Ground Reaction Forces)
기간: Baseline, 4-6 weeks
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A direct measure of vertical ground reaction forces during the rising phase of a sit-to-stand task (measured in Newtons) using standard force plates embedded in the floor.
Increased symmetry in ground reaction forces between the lower limbs reflects improved equalization of weight distribution between the limbs.
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Baseline, 4-6 weeks
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Change in Metabolic Efficiency (O2/kg/m)
기간: Baseline, 4-6 weeks
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A direct measure assessed during the six-minute walk test.
Metabolic efficiency is determined by the energy cost of transport, defined as oxygen consumption per unit body weight and distance walked (O₂/kg/m), which accounts for the individual's weight and walking speed.
Improved metabolic efficiency reflects enhanced oxygen delivery and utilization during walking.
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Baseline, 4-6 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Emily J Fox, PT, DPT, MHS, PhD, University of Florida & Brooks Rehabilitation
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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