- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00564343
a Water Training Program to Improve Balance in Chronic Stroke Patients
a Water Training Program to Improve Balance in Chronic Stroke Patients: Cross- Sectional Pre-Post Study Design
The proposed project is a case control study design. Subject's suffer from stroke willing to participate in the study will be shortly interviewed to assess eligibility according to the inclusion-exclusion criteria. Subjects suffer from chronic hemiplegia that upon questioning was judged to meet the following inclusion criteria: (a) able to stand independently 90 seconds; (b) able to walk 10 meters (with cane if necessary); (c) able to understand verbal instructions. The exclusion criteria will be: (a) Serious visual impairment; (b) Inability to ambulate independently (cane acceptable, walker not). (c) Severely impaired cognitive status (score less then 24 in Mini Mental State Examination). (d) Persons with impaired communication capabilities.
The whole project will be conducted over a period of 3 months. A total of 36 subjects will be assigned to water based exercise program. The exercise group will meet on 24 occasions over a period of 12 weeks (2 times/week). The subjects of the exercise group will be recruited from Sha'ar Ha'negev Swimming pool and from patients that get a Physical Therapy treatment Kupat Holim Clalit.
Gait and balance function will be tested in both groups with well established measuring techniques before and after the training period. The measuring techniques 1) Medical background variables. 2) Berg Balance Scale. 3) Late life Function and Disability Instrument. 4) Get up and go test - stand up and walk 3 meters turn around and walk back to the chair. 5) step execution test under single and dual task; 5) stability tests. 6) also fall will be monitored a year after the completion of the study. The water training intervention is performed on different levels where each level reflects different increasing demands on the postural control system. For example, the instructor can increase the difficulty of a certain water-exercise by instructing a participant to use less external support, close the eyes, decrease the support area (stand on one leg or narrow the stance, or on unstable surface). These "tools" allow the instructor to implement step exercises on a group level that are still challenging for each individual even if the skill level in the group varies. The water exercises also include perturbation exercises that trigger specific reflex-like balance responses. On each level the instructor can instantly modify an exercise to be more or less challenging for each participant.
연구 개요
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
-
-
-
Beer-Sheva, 이스라엘
- SorokaUMC
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Subjects suffer from chronic hemiplegia (a year or more)
- able to stand independently 90 seconds;
- able to walk 10 meters (with cane if necessary);
- able to understand verbal instructions.
Exclusion Criteria:
- Serious visual impairment;
- Inability to ambulate independently (cane acceptable, walker not).
- Severely impaired cognitive status (score less then 24 in Mini Mental State Examination).
- Persons with impaired communication capabilities.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
ChSt, water training, Observation
Subjects suffer from chronic hemiplegia (a year or more post stroke) that upon questioning was judged to meet the following inclusion criteria: (a) able to stand independently 90 seconds; (b) able to walk 10 meters (with cane if necessary); (c) able to understand verbal instructions.
The exclusion criteria will be: (a) Serious visual impairment; (b) Inability to ambulate independently (cane acceptable, walker not).
(c) Severely impaired cognitive status (score less then 24 in Mini Mental State Examination).
(d) Persons with impaired communication capabilities.
|
The exercise group will meet on 24 occasions over a period of 12 weeks (2 times/week), 45 minute training session.
|
연구는 무엇을 측정합니까?
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Berg Balance Scale
기간: fall will be monitored a year after the completion of the study.
|
fall will be monitored a year after the completion of the study.
|
|
Late life Function and Disability Instrument
기간: fall will be monitored a year after the completion of the study
|
fall will be monitored a year after the completion of the study
|
|
Get up and go test - stand up and walk 3 meters turn around and walk back to the chair
기간: fall will be monitored a year after the completion of the study
|
fall will be monitored a year after the completion of the study
|
|
Step execution test under single and dual task
기간: fall will be monitored a year after the completion of the study
|
fall will be monitored a year after the completion of the study
|
|
Stability tests
기간: fall will be monitored a year after the completion of the study
|
fall will be monitored a year after the completion of the study
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Dagan Shvartz, M.D., Ben-gurion University of the Negev, Beer-Sheva, Israel
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. .
만성 뇌졸중 환자에 대한 임상 시험
-
Hospital Clinic of BarcelonaAstraZeneca완전한CTO(Chronic Total Occlusion)를 위한 PCI(Percutaneous Coronary Intervention)를 받을 예정인 환자스페인
-
Institut National de la Santé Et de la Recherche...모병