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Effects of Training Rhythmic and Discrete Aiming Movements on Arm Control and Functionality After Stroke

2017년 1월 27일 업데이트: Renata Morales Banjai, Universidade Cidade de Sao Paulo

Effects of Training Rhythmic and Discrete Aiming Movements on the Upper Limb Control and Functionality After Stroke: Randomized Controlled Trial

The purpose of this study is to verify the additional effects of rhythmic specific training, discrete specific training additional to conventional therapy on the upper limb after chronic stroke subjects on the outcomes: motor control and functionality.

연구 개요

상태

알려지지 않은

정황

개입 / 치료

상세 설명

Seventy-five patients will be randomized into three groups to receive conventional therapy, consisting of a combination of mobility exercises joint, muscle stretching, strength training, motor coordination exercises, unilateral and bilateral motor tasks as well as oriented tasks training upper limb with a focus on functional tasks. The other groups will receive additional intervention consisting of aiming movement practice according two different protocols: discrete movements to targets placed in different directions and distances; and rhythmic movements also to targets placed in different directions and distances. Both additional interventional interventions will be conducted for 30 minutes over a 5 week-period (total: 10 sessions).

Clinical outcomes (motor control), functional and kinematic will be collected at baseline and at five weeks. Functional results will be collected at the beginning, after 5 weeks and 3 months after randomization. Data will be collected by a blinded assessor on patients' allocation group. All statistical analyzes will be carried out following the principles of intention to treat analysis and differences between groups will be performed using linear mixed models.

연구 유형

중재적

등록 (예상)

75

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 브라질
      • Sao Paulo, 브라질, 03071-000
        • 모병
        • Universidade Cidade de Sao Paulo
        • 연락하다:

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:patients who participate in the survey, adult stroke survivors (>18 years), with primary diagnosis of first-ever unilateral stroke (ischaemic or haemorrhagic), stroke experienced > 6 months prior to study enrollment and score ≥ 20 on the Folstein Mini Mental Status Examination.

Exclusion criteria: patients with excessive pain in the paretic hand, arm or shoulder excessive spasticity at the paretic elbow and wrist as defined as a score of 4 on the Modified Ashworth Spasticity Scale and upper limb comorbidities that could limit their functional recovery (e.g., arthritis, pain, other neurological disorders).

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
활성 비교기: Conventional Physical Therapy
Usual therapy: joint mobility exercises, stimulating joint movement of the main active components of the upper limb; major muscle groups stretching, especially in the affected muscles by tone impairment; manual resistance training according to the degree of the patient's muscle strength, prioritizing the functional specificity of the upper limb, so the majority of the exercises will be held in open chain; motor coordination exercises, unilateral and bilateral motor tasks as well as task-oriented training of the upper limb with a focus on functional tasks.
다른: Conventional Physical Therapy
Combination of joint mobility exercises, specific exercises for muscle strength and motor coordination exercises, unilateral and bilateral motor tasks as well as task-oriented training of the upper limb with a focus on functional tasks. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week)
실험적: discrete movement training group
Aiming movements training with the affected upper limb (unilateral training) or both limbs (bilateral training) on the surface of a table. The starting point of the movement and its target are predetermined. Targets will be placed in different directions and distances from the starting point and the therapist ask for variations on speed and assistance, if necessary.
다른: Discrete movement training group
Aiming movements training with the affected upper limb (unilateral training) or both limbs (bilateral training) on the surface of a table. The starting point of the movement and its target are predetermined. Targets will be placed in different directions and distances from the starting point and the therapist ask for variations on speed and assistance, if necessary.
실험적: rhythmic movement training group
Aiming movements training with the affected upper limb (unilateral training) or both limbs (bilateral training) on the surface of a table. The movement begins in a predetermined starting point, directed to a target and returns to the starting point. This activity is performed several times with rhythmic movements. Targets will be placed in different directions and distances from the starting point and the therapist ask for variations on speed and assistance, if necessary.
다른: Rhythmic movement training group
Aiming movements training with the affected upper limb (unilateral training) or both limbs (bilateral training) on the surface of a table. The movement begins in a predetermined starting point, directed to a target and returns to the starting point. This activity is performed several times with rhythmic movements. Targets will be placed in different directions and distances from the starting point and the therapist ask for variations on speed and assistance, if necessary.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Stroke Impact Scale (SIS)
기간: Five weeks after randomization and 3 months after randomization
Functionality: questionnaire which evaluates functionality. In this study will be evaluated four areas (arm muscle strength, hand function, activities of daily living and social participation)(Duncan et al., 1999). Each domain is scored from 1 to 5 (1 point corresponds to the worst possible outcome and 5 points to the best result). For the four areas the lowest possible score is 28 points and the highest is 125 points.
Five weeks after randomization and 3 months after randomization

2차 결과 측정

결과 측정
측정값 설명
기간
Motor Activity Log (MAL)
기간: Five weeks and 3 months after randomization

Arm function: individuals are asked to rate Quality of Movement (QOM) and Amount of Movement (AOM) during 30 daily functional tasks (original MAL) (Uswatte et al., 2005).

Items scored on a 6-point ordinal scale, where 0 corresponds to the weaker arm was not sued at all for that activity (never). Patients with a score 5 show the ability to use the weaker arm for that activity was as good as before the stroke (normal).
Five weeks and 3 months after randomization
Fugl-Meyer Assessment Scale
기간: Five weeks after randomization
Motor control: this scale assesses sensorimotor function of upper limb, with score 0-66 points with scores 0-66 points for motor function and 0-126 points for sensory-motor function (Fugl-Meyer, 1975). A higher score is better motor function.
Five weeks after randomization

기타 결과 측정

결과 측정
측정값 설명
기간
kinematics assessment
기간: Five weeks after randomization
Functional capacity: It will be used an experimental apparatus that analyzes the motor behavior the aiming movement (Ribeiro et al., 2014). They will evaluate the movement time (measured in milliseconds), reaction time (in milliseconds) and smoothness (expressed in units of motion). The movement time is the time interval between the beginning and the end of the movement. Reaction time is defined as the time between the start of the imperative stimulus to the beginning of the movement. The smoothness is evaluated by computing the number of times the acceleration zero crossing (positive to negative and vice versa). The resultant variable error (in centimeters) is a measure of variability for both the medial-lateral direction as anteroposterior, assessing the accuracy to hit the target.
Five weeks after randomization
Grip strength
기간: Five weeks after randomization
Body function and structure: it will measure the strength of grip and pinch through dynamometer. The results will be presented in kilogram-force (Kgf) (Mathiowetz et al., 1985)
Five weeks after randomization
Modified Ashworth Spasticity Scale
기간: Five weeks after randomization
Body function and structure: they will be assessed flexors elbow, wrist and fingers, and forearm pronators. A measurement scale from 0 to 4 points, with 0 representing normal muscle tone and 4 is the highest possible degree of spasticity (Bohannon and Smith, 1987)
Five weeks after randomization

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Universidade Cidade de Sao Paulo

수사관

  • 연구 책임자: Sandra R Alouche, PhD, Universidade Cidade São Paulo

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

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

2016년 6월 1일

기본 완료 (예상)

2018년 6월 1일

연구 완료 (예상)

2018년 9월 1일

연구 등록 날짜

최초 제출

2016년 4월 19일

QC 기준을 충족하는 최초 제출

2016년 5월 3일

처음 게시됨 (추정)

2016년 5월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2017년 1월 30일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 1월 27일

마지막으로 확인됨

2017년 1월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • Universidade Cidade Sao Paulo

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니

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. .

뇌졸중에 대한 임상 시험

Conventional Physical Therapy에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

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정황

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약물 개입

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스폰서 / 협력자

위치

구독하다