- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07642154
Comparison Between LL Sesorimotor Training and WBB Therapy on PS, DB and FOF in Post Stroke Patients
Comparison Between Lower Limb Sensorimotor Training and Whole-Body Vibration Therapy on Postural Stability, Dynamic Balance and Fear of Fall in Post Stroke Patients.
Stroke is a neurological disorder causing 70-80 percent deaths in the low income and developing countries. Patients commonly present with common impairments associated with balance, proprioception, poor gait, speech impairment and posture which affect the activities of daily living along with increased risk and fear of fall. This negatively impacts patients' mobility, confidence and role in the society. Lower limb sensorimotor training targets the integration of sensory and motor systems enhancing tactile stimulation, balance and proprioception; whereas whole body vibration stimulates muscle spindles and mechanoreceptors via mechanical oscillations that may promote reflexive muscle contractions, improve muscle tone, and enhance postural responses. The aim of this study is to find the comparative effects of lower limb sensorimotor training and whole-body vibration therapy on balance, posture and fear of fall in post stroke patients.
This study will be a randomized clinical trial. Non probability convenience sampling will be used to recruit 42 patients of either gender, aged 50-65 years, and diagnosed with stroke. This study will be carried out in Saira Memorial Hospital, Lahore. The participants will be randomly allocated to Group A and Group B through computerized table generator method. Each group will be given conventional physical therapy treatment as a baseline which includes range of motion exercises, balance and gait training. Group A will receive lower limb sensorimotor training, whereas group B will receive whole body vibration therapy. Each group will perform their respective exercises 45 minutes, three times a week for 8 weeks. The participants will be evaluated at the start and end of the exercise program through Berg Balance scale for dynamic balance, falls efficacy scale for risk of fall and Nottingham sensory assessment scale for sensory assessment. Data will be analyzed by SPSS version 26.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Dr. Mohammad Hassan, MS
- 전화번호: +923214375335
- 이메일: drhassandpt@gmail.com
연구 장소
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Punjab Province
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Lahore, Punjab Province, 파키스탄, 42000
- 모병
- Saira Memorial Hospital
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연락하다:
- Dr Mohammad Hassan, MS-SPT
- 전화번호: +923214375335
- 이메일: drhassandpt@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Both male and female ranging from 50-65 years.
- Definitive diagnosis of stroke .
- Having sensory issues due to stroke in lower extremities.
- Those who did not have a problem with walking due to other diseases other than stroke.
- Having score less than 45 on berg balance scale.
- Having no wounds, infections, and skin diseases in the feet, not taking medications such as nitroglycerin, dopamine, and dobutamine.
- Having no history of mental illness, no suffering from osteoporosis, and not having neurological diseases. (7)
Exclusion Criteria:
- Vestibular problems.
- Severe cognitive decline and aphasia
- Systemic diseases.
- Cerebellar-related diseases.
- Having acute and critical conditions during the intervention. (14)
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: Lower Limb Sensorimotor Training Exercises Group
Sensorimotor training Participants of this group will be given task-specific training (reaching and walking activities), sensory stimulation training (tactile and proprioceptive activities), balance and postural control training (single leg stance and balance board training), and bilateral training (active recovery such as slow walking and light movements, constraint-induced movement therapy including mirror therapy), as well as practice of functional activities of daily living (bathing, combing, and eating with utensils). (19) |
Component Frequency Intensity Time (minutes) Type Task- specific training 3 times per week Low to moderate 5 minutes Participants will perform reaching and walking activities. Sensory stimulation) 3 times/week Low to moderate 5 minutes Tactile and proprioceptive activities will be performed on participants. Balance/pos ture control 3 times/week Low to moderate 5 minutes Single leg stance and balance board training will be given to the patients. Bilateral training 3 times per week Low to moderate 5 minutes Active recovery (slow walking/light movement) exercises will be guided to the participants. Constraint- Induced Movement Therapy (CIMT) 3 times/week Low to Moderate 5 minutes Participants will involve in Mirror therapy. Functional activities (ADLs) 3 times per week Low to moderate 5 minutes Participants will perform functional activities like combing hair, pouring water, Eating with utensils, folding towels or clothes. |
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실험적: Whole Body Vibration Training Group
Participants in this group will be given whole body vibration therapy including standing while vibrating (feet shoulder width apart and knees slightly bent on whole body vibrator), mini squats performed while vibrating, seated or assisted vibration (participants will sit on a chair or cushion placed on the platform and receives vibration therapy), upper body training while vibrating (participants will perform task-oriented upper limb exercises along with vibration therapy).
The frequency of vibration for lower limb will be 11-z.(20)
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Component Frequency Intensity Time (minutes) Type Static Standing with vibration 3 times per week Low to moderate 5 minutes Participants stand with feet shoulder-width apart and knees slightly bent on whole body vibrator, receiving whole body vibration therapy. Mini Squats Performed while vibrating 3 times per week Low to moderate 5 minutes Participants perform min squats while receiving whole body vibration therapy Seated or Assisted Vibration 3 times per week Low to moderate 5 minutes Participants sit on a chair or cushion placed on the platform and receives vibration therapy. Upper Body Training while vibrating 3 times per week Low to moderate 5 minutes Participants will perform task-oriented upper limb exercises along with vibration therapy Vibration 3 times per Low to 5 minutes Participants will receive therapy along with functional tasks week moderate whole body vibration therapy while performing functional tasks like pegboard training |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Postural Stability
기간: 8 Weeks
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The Falls Efficacy Scale International is a measure of fear of falling or concerns about falling, developed as part of the Prevention of Falls Network Europe project between 2003 and 2006.
It is a 16-item questionnaire, useful for researchers and clinicians interested in assessing fear of falling.
The total score ranges from 16-64, with levels of concern classified as follows: Low Concern (16-19), indicating minimal concern about falling when engaging in daily activities; Moderate Concern (20-27), indicating a moderate level of concern and worry about falling during activities; and High Concern (28-64), reflecting a high level of fear and anxiety about falling during activities.(18)
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8 Weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Dynamic Balance
기간: 8 weeks
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Berg Balance Scale: The Berg Balance Scale is a widely used clinical tool to assess a person's static and dynamic balance abilities. It is a 14-item assessment scale that evaluates balance during various tasks. The Berg Balance scale is used to determine fall risk, predict length of stay in rehabilitation, and track progress in individuals with balance impairments (15) Cut-off scores for the elderly were reported by Berg et al. (1992). In this scale, a score of 56 indicates functional balance, a score of < 45 indicates a greater risk of falling, and a score of ≤ 49 indicates a risk of falls in individuals with stroke. (16) Studies of various elderly populations (N = 31-101, 60-90+ years of age) have shown high intra-rater and inter-rater reliability (ICC = .98, 14,15), a ratio of variability among subjects to total of .96-1.0 (16), and rs = .88 (17). Test-retest reliability in 22 people with hemiparesis is also high (ICC [2,1] = .98) (17) |
8 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Mohammad Hassan, Ms, Riphah International University
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 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. .
뇌졸중에 대한 임상 시험
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Institut National de la Santé Et de la Recherche...모병
Sensorimotor Training에 대한 임상 시험
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King's College LondonUniversity College, London; Brighton & Sussex Medical School완전한
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MMSx Authority Institute for Movement Mechanics...완전한
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VA Office of Research and Development아직 모집하지 않음