Shoulder, or Elbow, or Wrist: What Should we Train First After a Stroke?
The Effect of Proximal and Distal Training on Stroke Recovery
We will test on persons with chronic impairment due to stroke:
- whether the order in which robot therapy is delivered influences outcomes (shoulder-and-elbow before wrist vs. wrist before shoulder-and-elbow).
- whether we should train the shoulder, elbow, and wrist at the same time or on different days.
연구 개요
상세 설명
The Effect of Proximal and Distal Training on Stroke Recovery:
Specific Aim 1. Test whether task specific wrist robotic training improves motor performance among persons with chronic impairment after stroke.
Specific Aim 2. Test whether the order in which robot therapy is delivered influences outcomes (shoulder-and-elbow before wrist vs. wrist before shoulder-and-elbow).
Specific Aim 3. Test whether there is generalization across different joints (shoulder & elbow vs wrist).
Specific Aim 4: Test whether there is any interference between training across different joints among persons with chronic impairment after stroke.
Briefly we will invite persons with chronic impairment due to stroke to participate in a study that will train them first on wrist for 6 weeks and then on the shoulder-and-elbow for an additional 6 weeks or vice-versa. A third group will train in alternate days for 12 weeks on the shoulder-and-elbow or the wrist, while a fourth group will be trained on the shoulder, elbow, and wrist on the same day. Outcomes will be measured using standard instruments as well as robot-based measures. We expect that results from this study will provide an objective basis for maximizing this kind of therapy.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
-
-
New York
-
White Plains, New York, 미국, 10605
- Burke Medical Research Institute
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Patients will be included in the study if they meet the following criteria:
- naïve subjects who have never experienced robot-assisted therapy as inpatients or outpatients;
- first single focal unilateral lesion with diagnosis verified by brain imaging (MRI or CT scans) that has occurred at least 6 months prior;
- cognitive function sufficient to understand the experiments and follow instructions (Mini-Mental Status Score of 22 and higher or interview for aphasic subjects);
- average Motor Power score >= 1/5 or <= 3/5 (neither hemiplegic nor fully recovered motor function in 6 muscles of the shoulder, elbow, and wrist);
- informed written consent to participate in the study.
Exclusion Criteria:
Patients will be excluded from the study if they have a fixed contraction deformity in the affected limb.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: proximal to distal training
|
sequence of intervention
다른 이름들:
sequence of intervention
다른 이름들:
|
|
실험적: distal to proximal
|
sequence of intervention
다른 이름들:
sequence of intervention
다른 이름들:
|
|
실험적: proximal and distal on alternate days
|
sequence of intervention
다른 이름들:
sequence of intervention
다른 이름들:
|
|
실험적: proximal and distal same day
|
sequence of intervention
다른 이름들:
sequence of intervention
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Fugl-Meyer
기간: 3 times at baseline, midpoint, completion intervention, and at follow-up
|
3 times at baseline, midpoint, completion intervention, and at follow-up
|
|
Motor Power
기간: 3 times at baseline, midpoint, completion intervention, and at follow-up
|
3 times at baseline, midpoint, completion intervention, and at follow-up
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Wolf Motor Function
기간: 3 times at baseline, midpoint, completion intervention, and at follow-up
|
3 times at baseline, midpoint, completion intervention, and at follow-up
|
|
SIS
기간: 3 times at baseline, midpoint, completion intervention, and at follow-up
|
3 times at baseline, midpoint, completion intervention, and at follow-up
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Hermano I Krebs, PhD, Massachusetts Institute of Technology
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
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. .
rehabilitation robotics에 대한 임상 시험
-
Uskudar State Hospital아직 모집하지 않음폐 질환 | 폐 재활 | 원격 의료
-
Istituto Nazionale di Ricovero e Cura per AnzianiMinistero dell'Università e della Ricerca, Italia모병