- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01049581
Effects of Pediatric Aquatic Therapy in Children With Spastic Cerebral Palsy
Aquatic intervention had been applied in children with neuromotor impairment for years, yet there has been little progress toward objective identifications of therapy goals, interventions, and outcomes. Thus, we attempt to design aquatic intervention activity for children with cerebral palsy to evaluate the effect of hydrotherapy.
Purpose:
To evaluate the effects of pediatric aquatic therapy on motor performance, daily activity and social participation in children with spastic cerebral palsy.
Method:
The study enrolled 27 children with spastic cerebral palsy aged from 4 to 12 years old.These children were dived into two groups: traditional rehabilitation therapy (control group), and hospital based pediatric aquatic therapy program. We evaluate the motor performance, daily activity and social participation before and after the intervention and compared the difference in improvement between groups. The measurements include modified Ashworth score, Gross Motor Function Measure (GMFM -66), Vineland Adaptive Behavior Scale (VABS) , and Cerebral Palsy Quality of Life Questionnaire for Children (CPQOL).
Expect effect:
We suppose pediatric aquatic therapy in spastic cerebral palsy children could improve motor function and daily activity.Children could improve self-esteem and we hypothesize this could improve social participation.
연구 개요
상세 설명
- We conducted a well-designed study to investigate the effectiveness of PAT on motor function, activities of daily living (ADL),and health related quality of life(HRQOL) perspectives for children with CP.
- A convenience sample of 27 children was recruited for the study from the outpatient clinics of the Department of Physical Medicine and Rehabilitation of two tertiary hospitals: Chang Gung Memorial Hospital and Taipei Veterans General Hospital.
- The study was designed as a single blinded, prospective, case control study.
- The pediatric aquatic therapy group got more improvementon motor performance measured by GMFM-66.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Taipei, 대만
- Chang Gung Memorial Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Children diagnosed as cerebral palsy, spastic type
- Gross Motor Functional Classification (GMFCS) level II-IV
- Age: 4-12 y/o
- Informed consent by parents
- Modified Ashworth score 2 or3
- If participant history of epilepsy ,well controlled by medication
Exclusion Criteria:
- History of psychiatric diseases
- Poor controlled epilepsy
- Received botox injection or surgery in recent three months
- Children diagnosed as attention deficit hyperactivity disorder(ADHD) or autism
- Severe mental retardation
- Active infection (Body temperature > 100°F)
- Communication problems
- Bowel incontinence
- Bladder incontinence
- Severe cardiovascular disease
- Infectious skin conditions and open wound
- Nasogastric tubes or gastrostomy tubes
- Colostomy ,urostomy or ileostomy bags
- Acute orthopedic injury with pain and instability
- Diabetes
- Chlorine sensitivity
- Latex allergies
- Tracheostomy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: pediatric aquatic therapy
The children of the PAT group participated in a 1 hour/time, twice-per-week, 12-week, PAT program in addition to conventional rehabilitation programs
|
two hours per week, one hour per time, total 12 weeks
다른 이름들:
|
간섭 없음: conventional therapy
The children included in the control group continued with their original rehabilitation programs
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Unit on Gross Motor Function Measure Scale (GMFM)
기간: 3 months
|
The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy.
The scoring key is meant to be a general guideline.
However, most of the items have specific descriptors for each score.
It is imperative that the guidelines contained in the manual be used for scoring each item.
The score ranges from 0 to 100 and the higher represent the better gross motor function in children with cerebral palsy
|
3 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Daily Living Subscale of Vineland Adaptive Behavior Scale
기간: 3 months
|
Vineland Adaptive Behavior scale was developed by Sara et al at 1984 and was used to measure adaptive and maladaptive behavior in children age form 3-12 years-old.
The daily living subscale range from 0 to 198 and the higher the score represent the better captive behavior.
|
3 months
|
Subscale on Cerebral Palsy Quality of Life Questionnaire for Children
기간: 3months
|
This questionnaire was developed for Children and was a condition-specific quality of life (QOL) questionnaire for children with cerebral palsy aged 4 to 12 years.
It contains social , functioning, participation , emotional ,access, pain and disability, and family health components.
Participation is the main component in this study.
This sub score ranges from 0 to 81 , higher scores represent better participation
|
3months
|
공동 작업자 및 조사자
수사관
- 연구 책임자: ChiaLing Chen, Chang Gung Memorial Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
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. .
경련성 뇌성마비에 대한 임상 시험
-
Indiana UniversityNational Institutes of Health (NIH)모병
aquatic therapy에 대한 임상 시험
-
Baskent University아직 모집하지 않음경요도 절제술(TUR) 증후군
-
Medical University of South CarolinaNational Institute on Deafness and Other Communication Disorders (NIDCD)모집하지 않고 적극적으로
-
Alpha Tau Medical LTD.모병
-
Alpha Tau Medical LTD.European Organisation for Research and Treatment of Cancer - EORTC아직 모집하지 않음
-
University of Alabama at Birmingham완전한