Mental Practice Combined With Physical Practice to Improve the Gait Performance of People With Parkinson's Disease
연구 개요
상세 설명
Background: Among the impairments associated to Parkinson's disease, the gait disturbance is one of which that has the most negative impact on the independence in daily living activities and quality of life of people living with Parkinson's disease. Despite the considerable amount of research, we have no consensus about the most efficient physiotherapeutic approach to improve the gait disturbance. Mental practice is considered an efficient strategy to improve the motor performance in healthy individuals and people with stroke. However, there is scarce evidence about its therapeutic results to improve the gait performance in people living with Parkinson's disease.
Objectives: To investigate the effects of mental gait practice associated with physical practice to improve the gait performance of people living with Parkinson's disease.
Design: Parallel, prospective, double-blind, multicentre randomized clinical trial.
Setting: Brazilian Parkinson Association.
Participants: Twenty-two people living with Parkinson's disease in stages 2-3 of disease evolution according to Hoehn and Yahr Classification.
Interventions: The participants will be randomly allocated in an experimental group and a control group. Both groups will perform 10 individual training sessions, two times per week, for five weeks. The training sessions consist of four blocks of mental practice intercalated with four blocks of physical practice of gait under different conditions. The only difference between the groups will be the content of mental practice blocks: the experimental group will perform mental practice of gait while the control group performs non-gait mental practice.
Randomization: Participants will be randomized by ClinStat software into one of two groups: Experimental Group (EG), which will perform gait mental practice; and Control Group (CG), which will perform the non-gait mental practice.
Statistical analysis: The training effects for each primary and secondary outcome measure will be analyzed for the two training conditions (i.e., control and experimental) at the four assessment time points (i.e., pre-intervention, 7 days post-completion and at 30 and 60-day follow-up) using a mixed-design ANOVA with training as the between-group factor and the assessment time point as the within-group factor. The effect sizes (ES) will be calculated for all comparisons at alpha = 0.05. A Tukey HSD post-hoc test will be used for multiple comparisons and p-values below 5 % will be considered as statistically significant.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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São Paulo, 브라질, 04142-092
- Brazil Parkinson Association
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- diagnosis of Parkinson's disease according to the United Kingdom Brain Bank criteria;
- in stage 2-3 of the disease evolution according to the Hoehn and Yahr;
- treated with levodopa or its synergists;
- capable to walk independently indoors without aid;
- referring 5 years of education or more.
Exclusion Criteria:
- presence of other neurological (excluding PD), orthopedic or cardiopulmonary problems;
- visual and auditory deficiency uncorrected;
- dementia [assessed by Montreal Cognitive Assessment (MoCA), cut-off 26];
- depression [according to the Geriatric Depression Scale (GDS-15), cut-off 6];
- declined imagery capacity [according to the Revised Movement Imagery Questionnaire (MIQ-R) cut-off 10].
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 실험군(EG)
실험 훈련(ET)은 단일(ST) 및 이중 작업(DT) 조건에서 4개의 MP(GMP) 블록과 4개의 보행 물리적 연습(GPP) 블록이 삽입된 10개의 세션으로 구성됩니다.
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MP의 각 블록은 10개의 상상된 단계와 함께 5개의 정신적 걷기 시도로 구성됩니다. 참가자는 눈을 감고 편안하게 앉아 눈을 감고 1인칭 시점으로 4가지 다른 조건(습관적인 속도, 가능한 한 빠른 속도, 장애물 극복, 특정 약물. PP의 각 블록은 10걸음으로 구성된 5회의 물리적 걷기 시도로 구성됩니다. 참가자는 습관적인 속도, 가능한 한 빨리, 장애물 극복, 특정 약물의 이름 암기 등 4가지 다른 조건에서 걸으라는 요청을 받습니다. |
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활성 비교기: Control Group
The Control training (CT) consists of 10 sessions with 4 blocks of MP (nGMP) intercalated with 4 blocks of gait physical practice (GPP), under single (ST) and dual-task (DT) conditions.
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MP의 각 블록은 10개의 상상된 단계와 함께 5개의 정신적 걷기 시도로 구성됩니다. 참가자는 편안하게 앉아 눈을 감고 4가지 다른 상황(마차 안, 열기구 안, 보트와 제펠린에서. PP의 각 블록은 10걸음으로 구성된 5회의 물리적 걷기 시도로 구성됩니다. 참가자는 습관적인 속도, 가능한 한 빨리, 장애물 극복, 특정 약물의 이름 암기 등 4가지 다른 조건에서 걸으라는 요청을 받습니다. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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6분 걷기 테스트
기간: 최대 3개월
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6분 보행 테스트(6-MWT)는 참가자에게 습관적인 속도로 가능한 한 많은 거리를 6분 동안 걷도록 요청하는 시간 제한 권장 임상 기반 테스트입니다.
필요한 경우 휴식을 위한 중단이 허용됩니다.
6-MWT는 적절한 테스트-재테스트 및 인터레이터 신뢰성과 PD에서 82미터의 감지 가능한 최소 변화를 입증했습니다.
외부에서 독립적으로 안전하게 걸을 수 있는 능력을 잘 예측할 수 있습니다.
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최대 3개월
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Postural Instability and Gait Difficulty Score
기간: up to 3 months
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Postural Instability and Gait Difficulty Score (PIGD): This recommended rating scale for evaluation of gait alterations in PD is based on 5 Unified Parkinson's Disease Rating Scale (UPDRS) items relevant to gait and postural instability (items 13-15, 29, and 30).
The 13-15 items are based on gait performance according to PPD perspective, while 29 and 30 items are based on the motor test.
It is a recent rating scale that has been used in PD, evaluated independently, which has adequate clinimetric characteristics.
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up to 3 months
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Dynamic Gait Index
기간: up tp 3 months
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The balance during the eight gait related activities is scored in this test.
These include quality of walking speed change, going around and over obstacles and stair walking, as well as the number of steps required for a pivot turn.
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up tp 3 months
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30-second dual task gait
기간: up tp 3 months
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It measures the maximal walking distance reached in 30 seconds under single task, i.e., without another concurrent task, and dual task, i.e., with a concurrent cognitive task.
The cognitive task consists of speaking as many words as possible, starting with a specific character (F, S or A), presented at the beginning of test.
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up tp 3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Trail Making Test
기간: up to 3 months
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This test is constituted with two-timed parts: Part A, which involves a visual-scanning task where the participant is required to draw lines sequentially connecting consecutively numbered circles (1-25) randomly arranged on a page as fast as possible.
Part B, which assesses cognitive flexibility, where the participant is asked to connect the same number of circles in an alternating sequence of numbers and letters (1, A, 2, B, etc.).
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up to 3 months
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39-item Parkinson's Disease Questionnaire
기간: up to 3 months
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This scale assesses the health-related quality of life, i.e., the impact of an illness and/or treatment on patients' perception of their status of health and on subjective well-being or satisfaction with life.
It evaluates 39 parameters in eight groups of issues (mobility, ADL, emotional well-being, stigma of the disease, back in the next, cognitive, communication and bodily discomfort).
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up to 3 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Maria Elisa P Piemonte, PhD, Department of Physioterapy , Communication Science&Disorders, Occupational Therapy, School of Medicine, University of São Paulo
연구 기록 날짜
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연구 완료 (실제)
연구 등록 날짜
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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. .