Comprehensive Evaluation of the Passive Talaris Demonstrator
調査の概要
詳細な説明
Twenty-eight healthy active participants with an unilateral transtibial amputation will conduct 2 experimental trials (EXP1 & EXP2) on the same day in a randomized order, i.e. EXP1 with the currently used prosthesis and EXP2 with the passive Talaris Demonstrator. Each experimental trial will include 6 minutes of treadmill walking at 3 different speeds in consecutive blocks of 2 minutes, a slope walking test, a stair climbing test, a L-test and an outdoor walking task.
The six minutes walk test (6MWT) has become one of the most widely used performance-based outcome measures of functional mobility and exercise capacity. Recently, the 6MWT has been found to correlate with single-limb balance time and symmetry of step length in people with amputation. Additionally, the 6MWT distance has been shown to be responsive to functional training interventions in people with lower-limb amputation. Six minutes of treadmill walking at 3 different speeds will be performed. This test will be performed in consecutive blocks of 2 minutes. These consecutive blocks will be walking 2 minutes at self-selected (SS) speed, 2 minutes at 75% of the SS speed and 2 minutes at 125% of the SS speed. These different walking speeds elicit different angular positions of the ankle and activation levels of muscles, and thus might alter the effectiveness of the novel device.
The slope walking test assesses the participants' ability to ascend and descend a 6 m long ramp of 10% inclination as fast as possible. For safety reasons bilateral handrails are warranted. Participants start the test in an upright position in front of the ramp and are asked to ascend the ramp, turn around on the platform, descend the ramp and return to the starting position.
The stair climbing test assesses the participants' ability to ascend and descend a staircase (84 cm total height, 3-step staircase with an average rise of 28 cm and run of 18 cm). Participants start in front of the staircase and are asked to ascend and descend as fast as possible. Again, bilateral handrails are required to allow support when needed. The ascending phase is initiated with the prosthetic side, while the first step of the descending phase is performed with the non-involved leg.
The L-test, requires higher physical activity of the user. During the L-test, participants are asked to rise from a chair, walk 7 meters, turn 90 degrees, walk 3 meters, turn 180 degrees and then return in the same way to the seated position. A total distance of 20 meter is covered.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Brussels、ベルギー、1050
- Vrije Universiteit Brussel
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Unilateral transtibial (below knee) amputation
- Unilateral transfemoral (above knee) amputation
- Healthy subject
- Medicare Functional Classification Level: K2-4
Exclusion Criteria:
- Any neurological disease
- Upper limb or bilateral amputation
- Stump pain or bad fit of the socket
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:基礎科学
- 割り当て: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 |
---|---|
実験的:Novel prosthesis
A unilateral transtibial amputee will conduct experiments with the novel prosthesis followed by experiments with the current prosthesis.
|
The amputee will walk with the passive Talaris Demonstrator, a novel prosthetic foot, designed and built by "Axiles Bionics".
|
アクティブコンパレータ:Current prosthesis
A unilateral transtibial amputee will conduct experiments with the current prosthesis followed by experiments with the novel prosthesis.
|
The amputee will walk with the passive Talaris Demonstrator, a novel prosthetic foot, designed and built by "Axiles Bionics".
|
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 |
---|---|---|
Performance
時間枠:Through study completion, a period of 4 months
|
Heart rate during all tasks
|
Through study completion, a period of 4 months
|
Performance
時間枠:Through study completion, a period of 4 months
|
Time needed to perform the L-test
|
Through study completion, a period of 4 months
|
Performance
時間枠:Through study completion, a period of 4 months
|
Speed during 6 minutes walk test
|
Through study completion, a period of 4 months
|
Physiological
時間枠:Through study completion, a period of 4 months
|
Electromyography: lower limb muscle activity during different movements (% of the MVC)
|
Through study completion, a period of 4 months
|
Physiological
時間枠:Through study completion, a period of 4 months
|
Oxygen consumption during stair climbing, slope walking and during the 6 minutes walk test
|
Through study completion, a period of 4 months
|
Psychological
時間枠:Through study completion, a period of 4 months
|
Visual analogue scale for comfort (score: 0= not comfortable, 100 = comfortable) and fatigue (score: 0= not fatiguing, 100 = fatiguing) during all tasks
|
Through study completion, a period of 4 months
|
Biomechanical
時間枠:Through study completion, a period of 4 months
|
Joint angels and joint angular velocities of hip, knee and ankle joints
|
Through study completion, a period of 4 months
|
協力者と研究者
捜査官
- 主任研究者:Kevin De Pauw、Vrije Universiteit Brussel
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
本研究に関する用語
その他の研究ID番号
- BUN143201526629
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。