- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07579520
Effects of Rhythmic Auditory Stimulation on Range of Motion in Post- Fracture Rehabilitation of Lower Limb
Effects of Rhythmic Auditory Stimulation on Pain and Range of Motion in Children With Post- Fracture Rehabilitation of Lower Limb
연구 개요
상세 설명
Despite notable advancements in pediatric orthopedic rehabilitation, effective pain management and the restoration of functional range of motion continue to present significant challenges for children recovering from lower limb fractures. Traditional physiotherapy interventions largely emphasize manual therapy and structured exercise programs, often supplemented with pharmacological pain management. However, reliance on medications may lead to potential side effects and can negatively impact treatment adherence, particularly in pediatric populations. As a result, there is increasing interest in non-pharmacological approaches that can enhance rehabilitation outcomes while minimizing risks.
One such approach, Rhythmic Auditory Stimulation (RAS), has demonstrated considerable effectiveness in neurorehabilitation settings, including in conditions such as stroke, Parkinson's disease, and cerebral palsy. In these populations, RAS has been shown to improve motor coordination, regulate gait patterns, and positively influence pain perception through the use of rhythmic cues. Despite these promising outcomes, there remains a clear gap in the literature regarding the application of RAS within pediatric orthopedic rehabilitation, especially for children recovering from fractures.
Exploring the role of RAS in this specific context could provide valuable insights into its potential as an adjunct to conventional therapy. Integrating rhythmic auditory cues into rehabilitation programs may not only support improved physical outcomes, such as enhanced joint mobility and reduced pain, but also contribute to better emotional engagement and overall patient experience. Addressing this gap is essential for advancing evidence-based practice, expanding the use of innovative therapeutic techniques, and ultimately improving the quality of care and satisfaction for pediatric patients and their families.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Imran Amjad, PhD
- 전화번호: 03324390125
- 이메일: imran.amjad@riphah.edu.pk
연구 연락처 백업
- 이름: Muhammad Asif Javed, PhD*
- 전화번호: +923224209422
- 이메일: a.javed@riphah.edu.pk
연구 장소
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Punjab Province
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Lahore, Punjab Province, 파키스탄, 54000
- 모병
- CLC
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연락하다:
- MUBASHRA JABBAR
- 전화번호: 03291391075
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연락하다:
- Javeria khan
- 전화번호: 03041862547
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age range typically 5 to18 years
- Closed lower limb fracture (tibia, fibula, femur, ankle) treated non-surgically with immobilization (e.g., cast, splint, brace)
- Patients in rehabilitation stage (not immediate post-op trauma care)
- Sub-acute or post-casting phase where active ROM and gait training are clinically indicated
- Post-Fracture Stage: Within 4-6 weeks post-fracture
- Ability to Participate
- Able to follow instructions and participate in RAS sessions
- Medically stable and cleared for physical therapy.
Exclusion Criteria:
- Acute emergency management studies
- Presence of multiple fractures or other significant injuries.
- Known hearing impairments that may affect response to auditory stimulation.
- Presence of cognitive or neurological impairments that may affect participation.
- Pre-existing chronic pain conditions that may confound pain assessments.
- Recent surgeries or medical conditions that may contraindicate physical therapy or RAS.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Rhythmic Auditory Stimulation
The intervention involves applying Rhythmic Auditory Stimulation (RAS) through structured rhythmic cues or music during rehabilitation sessions alongside standard physiotherapy for children with lower limb fractures.
These rhythmic cues are synchronized with movement exercises to help with pain perception and joint range of motion during recovery.
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The intervention involves applying Rhythmic Auditory Stimulation (RAS) through structured rhythmic cues or music during rehabilitation sessions alongside standard physiotherapy for children with lower limb fractures.
These rhythmic cues are synchronized with movement exercises to help reduce pain perception and enhance joint range of motion during recovery.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain in lowerlimb
기간: 3 months
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changes from baseline in Pain will be assessed to determine the effectiveness of rhythmic auditory stimulation (RAS) during post-fracture rehabilitation in children with lower limb injuries.
Measurements will be taken before and after the intervention using an appropriate pediatric pain scale to evaluate any reduction in pain levels associated with the incorporation of rhythmic auditory cues alongside standard physiotherapy.
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3 months
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Range of Motion
기간: 3 months
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changes from baseline in Range of motion (ROM) refers to the degree of movement achieved at the affected lower limb joint during post-fracture rehabilitation.
It will be measured before and after the intervention to assess improvements in joint mobility following the application of Rhythmic Auditory Stimulation in combination with standard physiotherapy.
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3 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jawad Ahmed, MS PPT, Riphah International University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Riphah/G-III/RCR&AHS/B45-208
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
Rhythmic Auditory Stimulation에 대한 임상 시험
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