Investigation of the Effectiveness of Visual Feedback Training on Upper Extremity Functions in Cerebral Palsy
2018년 10월 29일 업데이트: Dilara Merve Sarı
Investigation of the Effectiveness of Visual Feedback Training on Upper Extremity Functions
The purpose of the study was to investigate the effectiveness of Cogniboard® Light Trainer, an education device with visual feedback that is added to the Neurodevelopmental Therapy Method (NDT) based upper extremity rehabilitation in children with cerebral palsy, on upper extremity functions such as joint range of motion (ROM), muscle tone, grip strength, pinch strength and functional abilities.
연구 개요
상태
완전한
정황
상세 설명
Children with the diagnosis of Cerebral Palsy, aged between 4 and 18 years were included in the study, who were volunteered to participate.
The participants were randomly assigned into two groups; A total of 16 sessions of rehabilitation program were applied for 2 days a week for 8 weeks.
The treatment programs applied are; Group I: NDT based upper extremity rehabilitation, Group II: NDT based upper extremity rehabilitation + Cogniboard® Light Trainer training.
In the cases, pre- and post-treatment spasticity was defined with 'Modified Ashworth Scale'; upper extremity joint range of motion (ROM) with 'goniometer'; grip and pinch strength with 'dynamometer'; hand skills with 'Minnesota Hand Skill Test'; functional abilities with 'Childhood Health Assessment Questionnaire (CHAQ) and functional level with 'Gross Motor Function Classification System (GMFCS)'.
연구 유형
관찰
등록 (실제)
38
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Eyup
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Istanbul, Eyup, 칠면조, 34050
- Dilbade Education and Rehabilitation Center
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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
4년 (어린이, 성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
확률 샘플
연구 인구
Participants of the study were selected among the children who applied to Dilbade Education and Rehabilitation Center for rehabilitation.
Simple random sampling method was applied to group selection.
설명
Inclusion Criteria:
- Having the diagnosis of Cerebral Palsy (CP),
- Aged between 4-18,
- Having 1+ upper extremity spasticity at max according to the Modified Ashworth Scale (MAS),
- To be able to cooperate with exercises
Exclusion Criteria:
- Having mental retardation report,
- Having congenital deformities,
- Epilepsy history,
- Having cardiac, orthopedic, visual and hearing problems,
- Application of Botulinum Toxin (BOTOX) to the upper extremity in past six month.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Group I
Group I: The control group.
Participants in this group received only NDT based upper extremity rehabilitation.
Number of the participants were 19.
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Group II
Group II: The study group.
Participants in this group received NDT based upper extremity rehabilitation + Cogniboard® Light Trainer training.
Number of the participants were 19.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Range of motion (ROM)
기간: Eight weeks
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Upper extremity ROM measured with universal goniometer.
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Eight weeks
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Spasticity
기간: Eight weeks
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Spasticity defined with Modified Ashworth Scale (MAS).
The MAS measures resistance during passive soft-tissue stretching.
Scoring: 0= normal tone.
1= slight increase in muscle tone, minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion or extension.
1+= slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder of the ROM.
2= more marked increase in muscle tone through most of the ROM, but affected part(s) easily moved.
3= considerable increase in muscle tone, passive movement difficult.
4= affected part(s) rigid in flexion or extension.
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Eight weeks
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Grip and pinch strength
기간: Eight weeks
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Grip and pinch strength measured with dynamometer.
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Eight weeks
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Hand Skills
기간: Eight weeks
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Hand skills was assessed with Minnesota Dexterity Test (MMDT).
MMDT is a standardized test for the evaluation of a subject's ability to move small objects various distances.
The score on the test is the total seconds required to complete chosen number of test trials.
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Eight weeks
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Functional Abilities
기간: Eight weeks
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Functional abilities was assessed with Childhood Health Assessment Questionnaire (CHAQ).
CHAQ is used to assess health status in children.
It assesses functional ability in 8 domains of physical function (30 items) for children.
Each item is scored on a four point scale ranging from 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), 3 (unable to do).
The mean score of the eight domains finally makes up the disability index and ranges from 0 (no disability) to 3 (disabled).
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Eight weeks
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Functional Level
기간: Eight weeks
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Functional level was defined with Gross Motor Function Classification System (GMFCS).
GMFCS looks at movements such as sitting, walking and use of mobility devices.
It provides a clear description of a child's current gross motor function.
Level I can climb stairs without the use of a railing.
Level II can walk in most settings and climb stairs holding onto a railing.
Level III needs usage of a hand held mobility device, may climb stairs holding onto a railing with assistance.
Level IV requires physical assistance or powered mobility in most settings.
Level V children are transported in a manuel wheelchair in all settings, they are limited in their ability to maintain antigravity head and trunk postures and control leg and arm movements.
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Eight weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Tugba Kuru Colak, Marmara University Institute of Health Sciences
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
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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 1월 8일
기본 완료 (실제)
2018년 5월 21일
연구 완료 (실제)
2018년 6월 1일
연구 등록 날짜
최초 제출
2018년 10월 27일
QC 기준을 충족하는 최초 제출
2018년 10월 29일
처음 게시됨 (실제)
2018년 10월 31일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 10월 31일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 10월 29일
마지막으로 확인됨
2018년 10월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- DilbadeEdRehabCtr
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
IPD 계획 설명
Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR) might be considered to be shared with clinicians studying in the same field one year after the publication of the study.
약물 및 장치 정보, 연구 문서
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아니
미국 FDA 규제 기기 제품 연구
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. .