- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05330741
Whole-Body Vibration Versus Gravity Force Stimulation on Postural Stability in Children With Down Syndrome
연구 개요
상태
정황
상세 설명
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Eman Wagdy
- 전화번호: 01008079576
- 이메일: Eman.wagdy@pt.bsu.edu.eg
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Children ages will be ranged from 8 to 10 years old.
- Functional hearing and vision.
- Mild and moderate mental retardation with IQ level (50-70) determined by a psychiatric specialist in the school (IQ measured by Stanford-Binet intelligence scale)
- Independent standing and walking.
Exclusion Criteria:
- Synptomatic pain.
- Musculoskeletal problems or/ atlanto-axial instability.
- Rheumatic and congenital heart disease
- History of previous surgical operation
- Regular participation in any sport activities.
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: Designed Physical Therapy Program
Designed Physical Therapy Program Down syndrome children will receive the designed physical therapy program for 1 hour.
The duration of treatment will be 3 times/week for 12 weeks.
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The designed physical therapy program include gentle stretching exercises, static muscle contraction, facilitation of trunk control from different positions, balance training from different positions on tilting board, facilitation of righting, protective and equilibrium reactions from different positions, facilitation of standing from different positions, gait training and, climbing stairs up and down.
|
|
실험적: Whole-Body Vibration
Designed physical therapy program in addition to whole-body vibration.
Down syndrome children will receive the designed physical therapy program for 1 hour in addition to whole-body vibration with an amplitude of 2 mm, vibration frequency ranged from 25 to 30 Hz and, vibration time ranged from 5 to10 minutes.
The duration of treatment will be 3 times/week for 12 weeks.
|
The designed physical therapy program include gentle stretching exercises, static muscle contraction, facilitation of trunk control from different positions, balance training from different positions on tilting board, facilitation of righting, protective and equilibrium reactions from different positions, facilitation of standing from different positions, gait training and, climbing stairs up and down.
The designed physical therapy program (mentioned before) + Whole-body vibration (WBV) training, child will be asked to stand with slightly flexed knees (30 degrees of knee flexion), and both feet will be placed at an equal distance from the center of the platform to achieve an equal distribution of body weight over both feet. The device will set to produce a peak-to-peak sinusoidal vibration with an amplitude of 2 mm and a vibration frequency ranged from 25 to 30 Hz. WBV will applied for (30 sec. of WBV, 1 min rest, 10 repetitions), (45 sec. of WBV, 1 min rest, 10 repetitions), (60 sec. of WBV, 1 min rest, 10 repetitions) in the 1st, 2nd. and 3rd. months respectively. |
|
실험적: Gravity Force Stimulation
Designed physical therapy program in addition to gravity force stimulation.
Down syndrome children will receive the designed physical therapy program for 1 hour in addition to gravity force stimulation with 10 repetitions for each position.
The duration of treatment will be 3 times/week for 12 weeks.
|
The designed physical therapy program include gentle stretching exercises, static muscle contraction, facilitation of trunk control from different positions, balance training from different positions on tilting board, facilitation of righting, protective and equilibrium reactions from different positions, facilitation of standing from different positions, gait training and, climbing stairs up and down.
The designed physical therapy program (mentioned before) + Gravity force stimulation child will be asked to maintain his balance on GFS during each of the following positions as a progression (standing and walking on the surface of two beams connecting the two boxes - standing and walking crossly on the surface of one beam connecting the two boxes - standing and walking sideward on the surface of one beam connecting the two boxes - standing and walking on the edge of the two beams - standing and walking on the edge of one beam: most difficult) |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Postural Stability
기간: Up to 12 weeks
|
Biodex Stability System will be used to measure overall stability index, anteroposterior stability index and mediolateral stability index.
|
Up to 12 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
기능적 이동성
기간: 최대 12주
|
기능적 이동성을 측정하기 위해 6분 걷기 검사가 사용됩니다.
이 검사는 피검자가 6분 동안 미리 측정된 거리를 따라 최대한 멀리 걸어가는 유산소 능력의 준최대 검사입니다.
|
최대 12주
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
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. .
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