Bio Leg: Advancing Mobility (BAM)
Adaptive Mobility Technology: A Comparative Study of C-Leg and Bio Leg
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Emily J Fox, PT, DPT, MHS, PhD
- 電話番号：904-742-2500
- メール：ejfox@phhp.ufl.edu
研究連絡先のバックアップ
- 名前：Joshua C Encarnacion, BS
- 電話番号：904-345-8969
- メール：Joshua.Encarnacion@brooksrehab.org
研究場所
-
-
Florida
-
Jacksonville、Florida、アメリカ、32216
- Brooks Rehabilitation
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：C-Leg
The first assessment will involve testing the participant with their current C-leg microprocessor prosthesis.
|
|
|
実験的：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.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in 6-Minute Walk Test (6MWT)
時間枠：Baseline, 4-6 weeks
|
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.
|
Baseline, 4-6 weeks
|
|
Change in Interlimb Symmetry (Ground Reaction Forces)
時間枠：Baseline, 4-6 weeks
|
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.
|
Baseline, 4-6 weeks
|
|
Change in Metabolic Efficiency (O2/kg/m)
時間枠：Baseline, 4-6 weeks
|
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.
|
Baseline, 4-6 weeks
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Emily J Fox, PT, DPT, MHS, PhD、University of Florida & Brooks Rehabilitation
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Bio-Legの臨床試験
-
Hanger Institute for Clinical Research and Education...University of Washington; U.S. Army Medical Research Acquisition Activity募集膝の上の下肢切断（損傷） | 切断 | 義足ユーザー | 手足;不在、先天性、低位 | 切断;外傷性、脚: 太もも、股関節と膝の間 | 膝上の下肢切断アメリカ
-
Otto Bock Healthcare Products GmbHHanger Clinic: Prosthetics & Orthotics積極的、募集していない
-
NovoBliss Research Pvt LtdZywie Ventures Privated Ltdまだ募集していません
-
Calvary Hospital, Bronx, NYNew York State Department of Health; RTS Family Foundation完了
-
Memorial Sloan Kettering Cancer Center募集NSCLC | 非小細胞肺がん | 間質性肺疾患 | 非小細胞肺がんステージ I | NSCLC、ステージ I | NSCLCステージII | 非小細胞肺がんステージ II | 結合組織疾患による間質性肺疾患（障害）アメリカ
-
Centre Hospitalier William Morey - Chalon sur SaôneCentre Hospitalier Universitaire Dijon; Centre Hospitalier Macon募集菌血症 | トモグラフィー、光コヒーレンス | バイオフィルム | 動脈カテーテル法、末梢フランス