- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07734818
Development and Validation of Mobile Application for Upper Limb Function in Stroke Survivors
연구 개요
상세 설명
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Haziqa Pari, MSNMPT
- 전화번호: +923044516865
- 이메일: haziqamalik44@gmail.com
연구 연락처 백업
- 이름: Aruba Saeed, Supervisor
- 전화번호: +92 334 4399403
- 이메일: aruba.saeed@ubas.edu.pk
연구 장소
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Punjab Province
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Lahore, Punjab Province, 파키스탄
- Lahore University of Biological and Applied Sciences
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연락하다:
- Aruba Saeed, PhD
- 전화번호: 0334 4399403
- 이메일: arubasaeedpt@gmail.com
-
Lahore, Punjab Province, 파키스탄, 54000
- Services Hospital
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연락하다:
- Aruba Saeed, Phd
- 전화번호: 0334 4399403
- 이메일: arubaseed@gmail.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
Subacute and chronic stroke patient > 3 months post stroke. Modified Ashworth scale <3 MOCA > 24. An ability to understand the command First ever stroke Grade II, III, IV on Functional mobility Scale Able to use and comprehend smart phone.
Exclusion Criteria:
Posterior circulation stroke. Vestibular disorders, paroxysmal vertigo Presence of other neurological conditions such as neglect, hemianopsia and pushing syndrome Presence of orthopedic diseases involving the upper limb
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Clinical Exercise group
Participants in the Clinical Exercise-Based Group will receive standard physiotherapy in a clinical setting, including range-of-motion, strengthening, task-specific functional, and repetitive motor exercises for the affected upper limb.
Sessions will be conducted 3 times per week for 45 minutes over 8 weeks following standardized clinical protocols.
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Range-of-Motion Exercises: Include passive, active-assisted, and active movements of the shoulder, elbow, wrist, and fingers along with stretching to maintain joint mobility and reduce stiffness. Strengthening Exercises: Involve resisted upper limb exercises using TheraBands, weights, and therapy tools to improve shoulder, elbow, forearm, wrist, and hand strength, including grip and pinch strengthening. Task-Specific Functional Activities: Focus on functional and daily-life tasks such as reaching, grasping, object manipulation, pegboard tasks, ADL simulations, fine motor activities, and repetitive bilateral upper-limb training to enhance coordination and motor recovery. |
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실험적: m Health
Participants receive upper limb rehabilitation via a mobile app with structured exercises for range of motion, strengthening, and functional tasks targeting the shoulder, elbow, wrist, and hand to improve motor control and coordination.
Sessions last 45 minutes, 3 times weekly for 8 weeks.
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Progressive Training Plan (8 Weeks) Phase I (Weeks 1-4): ROM & Early Activation:
Phase II (Weeks 5-8): Strengthening & Functional Training:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Wolf Motor Function Test
기간: The assesment will be done at baseline and after completion of 8 weeks.
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The Wolf Motor Function Test (WMFT) is a standardized tool for assessing upper limb motor function in stroke survivors (Wolf et al., 2001).
It includes 17 tasks: 15 timed functional activities (e.g., lifting objects, stacking) and 2 strength measures (grip and pinch).
It evaluates movement speed, function, and quality, with performance rated on a 6-point scale (0-5) and faster times indicating better ability.
The WMFT has high reliability (ICC > 0.90) and strong validity, correlating well with FMA and ARAT.
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The assesment will be done at baseline and after completion of 8 weeks.
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Fugl-Meyer Assessment - Upper Extremity
기간: The assesment will be done at baseline and after completion of 8 weeks.
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The Fugl-Meyer Assessment (FMA) is a widely used tool to measure motor impairment after stroke (Fugl-Meyer et al., 1975).
It evaluates upper limb function including reflexes, coordination, and voluntary movement of the shoulder, elbow, wrist, and hand.
The total score ranges up to 66, with higher scores indicating better motor recovery.
Each item is scored from 0 to 2, and the sum reflects overall performance.
It has excellent reliability (ICC > 0.95) and strong validity for tracking motor recovery over time.
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The assesment will be done at baseline and after completion of 8 weeks.
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Nine Hole Peg Test
기간: The assesment will be done at baseline and after completion of 8 weeks.
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The Nine-Hole Peg Test (NHPT) is a standardized, timed assessment used to measure fine motor dexterity of the upper limb (Mathiowetz et al., 1985).
Participants place and remove nine pegs from a pegboard as quickly as possible, and performance is recorded in seconds.
Lower completion time indicates better dexterity.
It shows high reliability (ICC 0.88-0.99)
and strong validity in stroke and other neurological conditions.
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The assesment will be done at baseline and after completion of 8 weeks.
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Malik AN, Afridi A, Rathore FA. Mobile Health (mHealth) Applications for Stroke Rehabilitation: A mini review. J Pak Med Assoc. 2024 Sep;74(9):1723-1726. doi: 10.47391/JPMA.24-74.
- Cao W, Li A, Kadir AA, Chen J, Chen L, Li Q, Hassan II. Older adult stroke survivors' needs and perspectives of a stroke app: a qualitative study. BMC Geriatr. 2025 Mar 29;25(1):212. doi: 10.1186/s12877-025-05849-1.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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
기타 연구 ID 번호
- UBAS/ERB/26/04/036 Haziqa
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
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