Clinical Evaluation of Instrumented Wheel as Biomedical Device Quantifying the Displacement Efficiency (FRM)
Clinical Evaluation of Instrumented Wheel of Wheelchair as Biomedical Device Quantifying the Displacement Efficiency
The purpose of this study is to validate an instrumented wheel such as a new biomedical device. The physicians will compare this instrumented wheel with another instrumentation "Ergometer roller", each patient will try the both instrumentations, physical and physiological parameters will be measured.
The increase rate of radial power during the cardiac stress test may be more important when the physicians use the instrumented wheel.
調査の概要
詳細な説明
* The manual wheelchair is used by people for whom walking is difficult or impossible due to spinal cord lesions, neurological and muscular diseases, lower limb trauma, age …etc.
Although the wheelchair help to regain mobility, this made of displacement is nor natural nor well-to-do.
- The CIC-IT and TSR (Transmissions Services Roulements, Mérignac, France) improved the instrumented wheel, adaptable with all wheelchairs, with information wireless transmission.
- The primary objective of study is to validate the instrumented wheel of manual wheelchair such as a new device of evaluation of capacities of displacement in ecologic situation.
- The primary criteria is to compare the mechanical power calculated using instrumented wheel versus the power calculated using ergometer roller during protocol of standard cardio-respiratory stress test.
This study is interventional, mono-centric, controlled and crossover. The population concerned is patients with spinal cord injury (SCI) and users of manual wheelchair.
Number of subjects projected for the entire study: 62 patients The total duration of participation of each patient: 7 days ±2days
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
-
-
Hauts-de-Seine
-
Garches、Hauts-de-Seine、フランス、92380
- Djamel Bensmail
-
-
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:
- Age : 18-70 years.
- Spinal cord injured patient.
- User of manual wheelchair for daily locomotion (having at least 30/100 at displacement items of WST questionnaire) .
- Affiliation to a social security scheme or entitled.
- Informed consent dated and signed by subject or subject's legally acceptable representative (and investigator).
Exclusion Criteria:
- Cognitive troubles.
- Progressive diseases: Tumoral, infectious, inflammatory and associated pathologies: brain injury, amputation.
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
- 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：Using of instrumented wheel and ergometer roller
The same patient will receive two types of tests: instrumented wheel and ergometer roller.
|
Using of instrumented wheel
Using of ergometer roller
|
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 |
|---|---|---|
|
Mechanical power calculated by instrumented wheel and ergometer roller.
時間枠：20 min
|
Comparison between mechanical power calculated by the instrumented wheel and mechanical power calculated by ergometer roller.
|
20 min
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Efficient fraction of total power calculated using instrumented wheel
時間枠：6 min
|
Tangential power / total power
|
6 min
|
|
Efficient fraction of total power calculated using ergometer roller
時間枠：15 min
|
Tangential power / total power
|
15 min
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Physiological parameters using instrumented wheel
時間枠：6 min
|
Heart rate, VO2 and Borg score.
|
6 min
|
|
Physiological parameters using ergometer roller
時間枠：15 min
|
Heart rate, VO2 and Borg score.
|
15 min
|
協力者と研究者
捜査官
- 主任研究者：Djamel Bensmail, MD、Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE, 92380 Garches, France
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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
- P101006
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