Implementation of a New Motor Skill Learning Therapeutic Device in Children With Cerebral Palsy Rehabilitation
2020년 12월 18일 업데이트: Yannick Bleyenheuft, Université Catholique de Louvain
Implementation of a New Interactive Interface Applying Motor Skill Learning Principles to Generate Motor, Functional and Neuroplastic Changes During High and Low Dosage Interventions in Children With Cerebral Palsy
Study of the efficiency of a new interactive interface to apply all the therapeutic principles of motor skill learning used in high dosage intensive interventions.
Investigation of its effects on motor, functional and neuroplastic changes in children after high and low dosage intensive interventions using or not the interface.
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (실제)
64
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Brussels, 벨기에, 1200
- Institute of Neuroscience, Université catholique de Louvain
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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
5년 (어린이, 성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- diagnosis of unilateral cerebral palsy
- MACS level I, II or III
- GMFCS level I, II, III
Exclusion Criteria:
- unstable seizure
- cognitive deficit that prevent understanding of simple games
- botulinic toxin injection, surgery, or another unusual intervention in the 6 months preceding the study and for the duration of the study
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 |
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활성 비교기: control group
high/low dosage intervention, intensive or not (motor function rehabilitation)
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Intensive intervention focusing on a constant bimanual coordination with a lower extremities and trunk control stimulation during play and functional activities.
50% of therapeutic time will be performed using the new interactive interface
Conventional therapy (physical and occupational therapy) is mainly based on neurodevelopmental therapeutic principles.
50% of therapeutic time will be performed using the new interactive interface
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실험적: interface group
high/low dosage intensive intervention using the interactive interface (motor function rehabilitation)
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Intensive intervention focusing on a constant bimanual coordination with a lower extremities and trunk control stimulation during play and functional activities.
50% of therapeutic time will be performed using the new interactive interface
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from baseline Assisting Hand Assessments score at 1 week post-camp
기간: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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The Assisting Hand Assessment has been developped to measure and describe the efficacy of use of the affected hand of children with unilateral cerebral palsy bimanual activity performance.
This is a standardized criterion-referenced test.
It is conducted as a recorded semi-structured play session using specific objects usually used in a bimanual manner.
With twenty-two test items, the child's performance is measured and obtain a sum score measure and a scaled score (percent scale).
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pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Change from baseline 6 Minutes Walking Test score at 1 week post-camp
기간: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Measurement developped to assess the exercise tolerance and walking abilities by asking the patient to walk as much as possible during 6 minutes in a 30 meters long corridor
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pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from baseline Box and Blocks test score at 1 week post-camp
기간: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Test measuring hand function through the number of blocks transported in 1 minute from one part an other of a box placed in front of the child.
Each hand tested separately
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pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Change from baseline Jebsen-Taylor Test of Hand Function score at 1 week post-camp
기간: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Measure of hand function/dexterity, through 7 activities simulating daily life activities.
Each hand is tested separately and time to complete each activity is reported using a stopwatch.
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pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Change from baseline Modified Cooper test at 1 week post-camp
기간: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Measurement of the stereognosis abilities.16
objects are placed in the hand and the child has to recognise the object only by touch.
both hands are tested separately and time to recognise the objects is reported using a stopwatch
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pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Change from baseline ABILHAND-Kids questionnaire score at 1 week post-camp
기간: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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questionnaire measuring performance of the child in daily life activities focusing on the upper extremities.
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pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Change from baseline ACTIVLIM-CP questionnaire score at 1 week post-camp
기간: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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questionnaire measuring performance of the child in daily life activities focusing on upper and lower extremities.
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pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Change from baseline ABILOCO-Kids questionnaire at 1 week post-camp
기간: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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questionnaire measuring performance of the child in daily life activities focusing on the lower extremities.
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pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Change from baseline Pediatric Evaluation of Disability Inventory score at 1 week post-camp
기간: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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questionnaire measuring performance of the child in daily life activities focusing on the upper extremities and lower extremities.
Only the self-care domain will be assessed here
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pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Change from baseline Canadian Occupational Performance Measure scores at 1 week post-camp
기간: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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The Canadian Occupational Performance Measure is a measure designed to capture the patient's self-perception of performance in everyday living, over time.
It consist of a semi-structured interview were the patient elicits daily life activities performed with difficulties (self-care, nutrition, transfer, household management, school, work, transport, leisure, etc).
Five activities are then chosen as the most important to improve and score on a 1 to 10 scale based on the actual patient's performance and satisfaction levels.
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pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Change from baseline MHAVIE-child questionnaire score at 1 week post-camp
기간: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Questionnaire measuring social participation
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pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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)
2018년 6월 14일
기본 완료 (실제)
2020년 6월 20일
연구 완료 (실제)
2020년 7월 15일
연구 등록 날짜
최초 제출
2018년 6월 21일
QC 기준을 충족하는 최초 제출
2019년 4월 26일
처음 게시됨 (실제)
2019년 4월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 12월 21일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 12월 18일
마지막으로 확인됨
2020년 12월 1일
추가 정보
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