Effects of Training in a Virtual Environment in Chronic Stroke Patients
2018년 11월 1일 업데이트: University of Sao Paulo General Hospital
Effects of Training in a Virtual Environment on the Motor Function,Postural Control and Quality of Life in Chronic Stroke Patients: A Randomized Controlled Trial
The objective of this work will be compare the effects of two balance training programs, one Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system, on the (1) motor function, (2) cognition, (3) balance and (4) gait in chronic stroke patients.
It is a prospective, single blinded, randomized clinical trial performed at Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University.
Forty patients will be randomly assigned in control and experimental group, 20 each one.
연구 개요
상세 설명
The objective of this work is to compare the effects of two balance training programs, one Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system, motor function, balance and quality of life in chronic stroke patients.
It is a prospective, single-blinded, randomized clinical trial performed at Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University.
Forty chronic stroke patients are randomly in control and experimental group, 20 each one.
Both groups conduct 14 training sessions, twice a week, for seven weeks.
Each session will consist a 30 minute-global-exercise series including stretching, muscle strength and axial mobility exercises.
After this, both groups will performed more 30 minutes of balance training: the control group will performed balance exercises without external cues, visual or auditory feedbacks or cognitive stimulations; the experimental group will performed the balance training with 8 Wii Fit games which stimulate motor and cognitive functions.
The main outcome measures will be: (1) the lower limb subscale of the Fugl-Meyer Assessment (FMA-LE); (2); Balance Evaluation Systems Test (BESTest);(3) the Stroke-Specific Quality of Life (SS-QOL); (4) 6- minute walk test (6MWT) and (5) The limits of stability (LOS).
연구 유형
중재적
등록 (실제)
40
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
-
São Paulo, 브라질, 05360-160
- Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy, School of Medicine, University of São Paulo
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- hemiparetic status resulting from a single stroke at least 6 months earlier;
- the ability to walk 10 m independently with or without an assistive device;
- the absence of a musculoskeletal condition that could potentially affect the ability to walk safely;
- the absence of serious visual impairment or a hearing disorder;
- power of at least grade 3 in the hemiplegic lower extremity;
- able to understand and follow simple instructions.
Exclusion Criteria:
- a Montreal Cognitive Assessment (MoCA) score of < 20;
- severe dementia or aphasia;
- hemispatial neglect, ataxia or any other cerebellar symptom;
- inability to stand without minimal assist;
- Impaired vision
- Uncontrollable medical complications
- participation in other studies or rehabilitation programs
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Virtual Reality Training
The virtual reality training will be done by experimental group with ten games of Nintendo Wii Fit.
|
The participants of the study will be trained 8 balance games during 14 sessions
|
|
활성 비교기: Control group: Physical Therapy
The Control Group will be trained by conventional Physical Therapy exercises.
|
Patients of the control group will be trained with balance exercises.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The lower limb subscale of the Fugl-Meyer Assessment (FMA-LE)
기간: up to 2 months
|
FMA-LE is a subscale measuring lower limb motor recovery.
It examines movement and coordination of the hip, knee, and ankle in the supine, sitting, and standing positions.
Each item is scored on a 3-point scale (0, cannot perform; 1, partially performs; 2, performs fully).
The score range is 0 to 34, with higher scores indicating better lower limb motor performance
|
up to 2 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Balance Evaluation Systems Test (BESTest)
기간: Up 2 months
|
Balance Evaluation Systems Test (BESTest) measures balance.
It includes 36 items that evaluate performance of 6 balance systems: biomechanical constraints, stability limits/verticality, anticipatory postural adjustments, postural responses, sensory orientation, and stability in gait.
|
Up 2 months
|
|
6-minute walk test
기간: Up to 2 months
|
The 6MWT is a practical simple test.
This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD).
The 6MWT has been used as a measure of functional status of patients.
|
Up to 2 months
|
|
Stroke specific quality of life scale
기간: Up to 2 months
|
Stroke Specific Quality of Life Scale is a self-report assessment that includes 12 stroke specific subscales with 49 items.
The Stroke Specific Quality of Life Scale attempts to capture the domains of stroke specific QOL that are insufficiently assessed with generic QOL measures.
The 12 subscales, which are unidimensional, are Energy, Family Role, Language, Mobility, Mood, Personality, Self-Care, Social Roles, Thinking, Upper Extremity Function, Vision, and Work-Productivity.
Participants responded to each item on a 5-point scale.
Domain scores are the averages of the item scores, and the total score is the average of the domain scores.
All summary scores therefore range from 1 to 5. Higher scores indicate better function.
|
Up to 2 months
|
|
Limits of Stability
기간: Up to 2 months
|
The Limits of Stability subtest quantifies the maximum distance a person can intentionally displace their center of pressure (COP) from start position of midline COP centered over the base of support to eight targets.
Location and movement of the COP was indicated by a cursor display projected on a screen in front of the subject.
As targets were highlighted, the subject was to move the COP cursor quickly and accurately as possible towards a target located on the Limits of Stability perimeter and hold position as close to the target as possible.
The parameters include COP movement velocity and directional control (% to target).
|
Up to 2 months
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Tatiana P Oliveira, PhD student, University of Sao Paulo
- 수석 연구원: Camila S Miranda, Ms Student, University of Sao Paulo
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2014년 2월 1일
기본 완료 (실제)
2017년 6월 1일
연구 완료 (실제)
2018년 2월 1일
연구 등록 날짜
최초 제출
2013년 6월 20일
QC 기준을 충족하는 최초 제출
2013년 6월 20일
처음 게시됨 (추정)
2013년 6월 25일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 11월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 11월 1일
마지막으로 확인됨
2018년 7월 1일
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. .