- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07712315
Effects of Vestibular Stimulation in Addition to Conventional Physiotherapy in Improving Gross Motor Function and Mobility in Children With Spastic Diplegic Cerebral Palsy
연구 개요
상태
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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KPK
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Mansehra, KPK, 파키스탄, 25000
- Ibadat International University, Islamabad
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
• Participants with age limit of 6-12 years
- Diagnosed cases of Spastic Diplegic Cerebral Palsy by Pediatric neurologist
- Both genders (male/female)
- Participants with GMFCS Level I-III
- Participants with Grade I spasticity, Modified Ashworth Scale (MAS) • Participants able to understand and follow basic commands.
Exclusion Criteria:
• Children with history of vestibular disorders, epileptic fits or uncontrolled seizures from past six months
- Children with any surgical procedure of the spine or lower limbs or Botox treatment in the last 6 months
- Children with any visual or hearing impairment
- Children having any fixed deformity, contracture or fracture limiting participation in therapy
- Patients having VP shunt
공부 계획
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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실험적: Experimental Group A received Vestibular Stimulation along with Conventional therapy.
Participants in this group received Vestibular Stimulation along with Conventional therapy.
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Experimental Group A received Vestibular Stimulation along with Conventional therapy.
Vestibular stimulation included Multi-directional swinging , Trampoline jumps , Rocking movement , Gaze stabilization exercises , Visual pursuit exercises , Passive soft tissue stretching , Lower limb resistance exercises , Balance board training , Movement transitions.
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활성 비교기: Control Group B received Conventional physiotherapy alone.
Participants in this group received Conventional physiotherapy alone
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Control Group B received Conventional physiotherapy alone which includes Passive soft tissue stretching , Lower limb resistance exercises , Balance board training , Movement transitions.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Gross Motor Function Measure (GMFM-88)
기간: Assessment was performed at baseline and after 6 weeks of intervention.
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Gross Motor Function Measure (GMFM-88) will be used to assess the progression of gross motor function over time in cerebral palsy affected children. The original GMFM version has 88-items and divided into five dimensions. each item scored on a 4-point ordinal scale of 0 to 3, where:
Scores for each group are expressed as a percentage of the its highest score and the total score is calculated by summing the percentage scores for each of the five groups/dimensions. |
Assessment was performed at baseline and after 6 weeks of intervention.
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10-Meter Walk Test (10MWT)
기간: Assessment was performed at baseline and after 6 weeks of intervention
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The 10 Meter Walk Test was used to determine functional mobility in children with spastic diplegic cerebral palsy.
The test will be conducted on a 14 m pathway, including the starting and ending points, with a 2 m walk-in section.
The time taken to reach the midpoint of the 10 m walk will be recorded.
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Assessment was performed at baseline and after 6 weeks of intervention
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Timed Up and Go (TUG) test
기간: Assessment was performed at baseline and after 6 weeks of intervention.
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Mobility of children was evaluated via timed get up and go (TUG) test and its results were recorded.(15) In this test, the duration of standing up from an armchair, walking up to 3 m, turn walk back, and sitting on the chair was measured. (16) Interpretations are as follow:
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Assessment was performed at baseline and after 6 weeks of intervention.
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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. .