Gait Training With Executive Functions Tasks in Subjects With Parkinson´s Disease: A Randomised Controlled Trial
Gait Training Associated With Executive Functions Tasks in Subjects With Parkinson´s Disease: A Randomised Controlled Trial
The aim of this study is to compare two physical therapy training consisting of gait training that are distinguished by one being associated with tasks that require handling of the main executive functions, performed by individuals with Parkinson's Disease.
The investigators hypothesis is that the experimental group (EG), which hold gait training with higher cognitive demands (dual-task condition), will make improvements in the parameters measured (functionality of gait and cognitive ability) to a greater extent compared to the control group (CG), which hold gait training without executive tasks (single-task condition).
연구 개요
상세 설명
The aim of this study is to compare two physical therapy training consisting of a gait training that are distinguished by one being associated with tasks that require handling of the main executive functions (protocol designed by the same team), performed by individuals with Parkinson's Disease.
Both training consists of 30 minutes of global exercises that involves stretching, muscle strengthen and axial mobility exercises, with the following difference:
- the experimental group (EG) will hold another 30 minutes of gait training in a dual-task condition associated with distracting tasks that require handling of the main executive functions;
- the control group (CG) will hold an additional 30 minutes of gait training without associated tasks.
It will be a prospective study, single blind, randomized, where 30 patients with PD in stages 1 to 3 on Hoehn & Yahr scale will participate in the study, to be held in Brazil Parkinson Association. Patients will be randomized into an experimental and control group, 15 in each one.
The training will consist of 10 sessions, two times per week for five weeks. The executive tasks concomitant with gait training cover the following executive functions: volition, self-awareness, planning, response inhibition, response monitoring and attention.
The main outcome measures are: (1) Dynamic Gait Index (DGI), (2) Montreal Cognitive Assessment (MoCA), (3) Trail Making Test A and B, (4) Unified Parkinson's Disease Rating Scale (UPDRS) and (5) Falls Efficacy Scale (FES).
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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São Paulo, 브라질
- 모병
- Brazil Parkinson Association
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연락하다:
- Grossmann, President
- 전화번호: 55-11-25788177
- 이메일: parkinson@parkinson.org.br
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수석 연구원:
- Cynthia B Ferrari, PhD Student
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Diagnosis of Idiopathic PD performed by a neurologist specialist in movement disorders;
- In use of dopaminergic medication;
- Disease severity of 1 to 3 according to Hoehn & Yahr scale;
- Absence of other neurological disorders or co-morbidities that may affect gait;
- Absence of dementia (score above 24 on the Mini Mental State Examination - MMSE);
- Vision and hearing adequate or corrected to normal;
- Ability to walk independently;
- Absence of prolonged off state;
- Age 50 to 85 years.
Exclusion Criteria:
- Biomechanical alterations (other pathologies) that could compromise the completion of training;
- Presence of depression, detected by the Geriatric Depression Scale (GDS-15);
- Presence of any neurological, auditory or visual deficit that could compromise distracting task performance during gait training;
- Any changes in drug treatment for PD.
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 |
|---|---|
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실험적: Gait training executive functions tasks
The experimental group will perform a gait training associated with the tasks that require the main executive functions (dual-task condition).
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훈련은 주 2회, 5주 동안 10회기로 구성되며, 스트레칭, 근력 강화, 축 모빌리티 운동을 포함하는 글로벌 운동 30분과 이중 과제 조건에서 보행 훈련 30분으로 구성된다. 의지, 자기 인식, 계획, 반응 억제, 반응 모니터링 및 주의와 같은 주요 실행 기능을 처리해야 하는 산만한 작업.
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활성 비교기: Gait training alone
The control group will perform a gait training alone, without associated tasks (single-task condition).
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The training will consist of 10 sessions, two times per week for five weeks, and consists of 30 minutes of global exercises that involves stretching, muscle strengthen and axial mobility exercises, and another 30 minutes of gait training alone, without other tasks.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Dynamic Gait Index
기간: 05/2013 (Up to ten months)
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The scale assesses the ability to adapt the gait during motor tasks with different demands.
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05/2013 (Up to ten months)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Montreal Cognitive Assessment
기간: 05/2013 (Up to ten months)
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This scale was developed in order to detect mild degrees of cognitive impairment.
The instrument assesses different cognitive domains such as attention and concentration, executive functions, memory, language, visuo-constructive skills, calculations, and orientation.
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05/2013 (Up to ten months)
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공동 작업자 및 조사자
수사관
- 연구 책임자: Maria Elisa P Piemonte, PhD, University of Sao Paulo
- 수석 연구원: Cynthia B Ferrari, PhD Student, University of Sao Paulo
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
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. .
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