- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07655973
Foot Intensive Rehabilitation With Perturbation Based Training in Ankle Sprain Patients
Foot Intensive Rehabilitation With & Without Perturbation Based Training in Patients With Ankle Sprain
To determine the foot-intensive rehabilitation with and without perturbation-based training on pain reduction, range of motion improvement, balance enhancement, and functional instability in patients recovering from ankle sprains NULL HYPOTHESIS There will be no significant difference in the effectiveness of foot-intensive rehabilitation with perturbation-based training compared to foot-intensive rehabilitation alone in reducing pain, improving range of motion, enhancing balance, or reducing functional instability among patients recovering from ankle sprains.
ALTERNATE HYPOTHESIS There will be a significant difference in pain reduction, range of motion improvement, balance enhancement, and reduction in functional instability between patients undergoing foot- intensive rehabilitation with perturbation-based training compared to those undergoing foot-intensive rehabilitation.
Study Design:
It will be a Randomized Clinical Trial
Study Population:
Ankle Sprain Both groups will undergo the assigned interventions for the duration of 6 weeks under the supervision of trained physical therapists or healthcare professionals. The interventions will aim to address pain reduction, range of motion improvement, balance enhancement, and reduction in functional instability among participants recovering from ankle sprains.
연구 개요
상태
정황
상세 설명
Group A: Foot-Intensive Rehabilitation with Perturbation-Based Training
Foot-Intensive Rehabilitation:
Participants in Group A will undergo a structured rehabilitation program focused on addressing ankle sprains and improving foot-specific impairments. This program will typically include:
- Therapeutic Exercises: Range of motion exercises, strengthening exercises for foot and ankle muscles, proprioceptive training, and flexibility exercises tailored to individual needs.
- Manual Therapy: Hands-on techniques performed by a physical therapist or trained personnel to address soft tissue restrictions, joint mobilization, and mayofascial release.
- Modalities: Use of modalities like ice, heat, ultrasound, or electrical stimulation for pain relief and enhancing tissue healing.
- Functional Training: Specific drills and activities mimicking daily tasks or sports- related movements to improve functional capacity.
Perturbation-Based Training: In addition to the foot-intensive rehabilitation program, participants will undergo perturbation-based training sessions:
- Balance Challenges: Engaging in exercises on unstable surfaces (e.g., balance boards, foam pads) or using devices inducing controlled instability to challenge balance and neuro- muscular control.
- Dynamic Movements: Performing controlled perturbations or sudden movements to elicit adaptive responses and improve reactive balance strategies.
- Progression: Gradual progression of difficulty and complexity in perturbation-based exercises based on individual tolerance and improvement.
Group B: Foot-Intensive Rehabilitation without Perturbation-Based Training
Foot-Intensive Rehabilitation:
Participants in Group B will receive the same structured rehabilitation program focusing on foot- intensive exercises as in Group A. This program includes similar components such as therapeutic exercises, manual therapy, modalities, and functional training targeting ankle sprain recovery and foot-specific impairments.
Both groups will undergo the assigned interventions for the duration of 6 weeks under the supervision of trained physical therapists or healthcare professionals
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Punjab Province
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Lahore, Punjab Province, 파키스탄, 54000
- Pakistan sports board
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
• Gender: male /female
- Participants aged 18 to 35 years old.
- Diagnosis of an ankle sprain (within 4 weeks of injury).
- No prior history of severe ankle fractures or surgeries(Hoch et al., 2023)
Exclusion Criteria:
- Presence of severe or complex ankle fractures requiring surgical intervention.
- Conditions other than ankle sprain like neuropathy that affect balance or cutaneous sensation.
- Neurological disorders impacting balance or proprioception.
- Pregnancy or planning to become pregnant during the study period(Hoch et al., 2023)
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 |
|---|---|
|
활성 비교기: Foot-Intensive Rehabilitation
Foot-Intensive Rehabilitation: Participants in Group A will undergo a structured rehabilitation program focused on addressing ankle sprains and improving foot-specific impairments |
Foot-Intensive Rehabilitation This program will typically include:
|
|
실험적: Foot-Intensive Rehabilitation + Perturbation-Based Training
In addition to the foot-intensive rehabilitation program, participants will undergo perturbation-based training sessions
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In addition to the foot-intensive rehabilitation program, participants in experimental group will undergo perturbation-based training sessions:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Numeric pain rate scale (NPRS)
기간: 6 weeks (Baseline, 3rd week, 6th week)
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Patient level of pain will be assessed using this scale.
This scale ranges from 0 to 10. 0 indicates "no pain" and 10 indicates "worst pain" (Riley et al., 2019)
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6 weeks (Baseline, 3rd week, 6th week)
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Range of Motion (ROM) Measurement
기간: 6 weeks (Baseline, 3rd week, 6th week)
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Goniometer: To measure dorsiflexion, plantarflexion, inversion, and eversion of the ankle joint(Rome & Cowieson, 1996).
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6 weeks (Baseline, 3rd week, 6th week)
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Balance Assessment:
기간: 6 weeks (Baseline, 3rd week, 6th week)
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Star Excursion Balance Test (SEBT): Measures reach distances in multiple directions to assess dynamic balance and reach symmetry.(Coughlan
et al., 2012)
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6 weeks (Baseline, 3rd week, 6th week)
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Functional Instability Measurement
기간: 6 weeks (Baseline, 3rd week, 6th week)
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Cumberland Ankle Instability Tool (CAIT): A questionnaire to assess the severity of functional ankle instability.(ALEXANDRE
et al., 2024)
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6 weeks (Baseline, 3rd week, 6th week)
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Sana Akram, MSOMPT, University of Lahore
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 연구와 관련된 용어
기타 연구 ID 번호
- UOL/IREB/25/15/03/10
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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