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临床试验/CTRI/2025/11/097112
CTRI/2025/11/097112招募中不适用

Effectiveness and Adherence to a task oriented home exercise program on upper limb motor recovery and functional arm usage in individuals with subacute Middle Cerebral Artery Stroke

KMCH College of Physiotherapy1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
44
试验地点
1
主要终点
1. Motor Recovery using Fugl-Meyer assessment Upper Extremity.

研究概览

简要总结

The aim of the study is to evaluate effectiveness and adherence to a task oriented  home exercise program on upper limb motor recovery and functional arm use in real life activities of stroke individuals.Prior to participation, the purpose and details of the study will be thoroughly explained to all eligible individuals. A written informed consent form will be obtained from each individual. Baseline assessments will be conducted prior to the intervention period. Then the upper limb motor recovery will be evaluated using Fugl Meyer Upper Extremity and Functional arm use evaluated by Motor Activity Log14.The experimental group receive real life functional Task Oriented exercises in Home setup along with certain associated exercises included as part of the intervention for 4 weeks, and control group receive Conventional therapy (Standard usual clinical practice). Both groups will receive treatment for  duration of 6 days per week for 4 weeks for 45min. To both groups Post-intervention, the same measures will be used to reassess functional change and adherence level  by Stroke Specific Measure of Adherence to Home based Exercise at end of 4 weeks.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
35.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.Early Subacute Middle Cerebral Artery Stroke individuals 2.Both Ischemic and Hemorrhagic Stroke
  • Both Dominant and Non – dominant hand affected.
  • 5.Able to sit without support for thirty sec
  • Individuals who require manual contact of no more than one person during ambulation on level surface to prevent falling or Manual contact consists of continuous or intermittent light touch to assist balance or coordination according to Functional Ambulation Category score more than 2 .

排除标准

  • Severe cognitive impairment
  • Severe joint pain caused by various factors affecting functional activities.
  • Other neurological disorders – Parkinson’s disease, Multiple Sclerosis
  • Musculoskeletal disorders like Periarthritis shoulder, Rheumatoid arthritis and contractures.
  • Sivere spasticity
  • Visual or sensory impairments
  • Apraxia and unilateral spatial neglect.
  • Sensory and Global aphasia.
  • Cardiological conditions with unstable angina, symptomatic heart failure, uncontrolled hypertension.

结局指标

主要结局

1. Motor Recovery using Fugl-Meyer assessment Upper Extremity.

时间窗: 1. Baseline | 2.Post test at 4th week

2. Functional arm use using Motor Activity Log 14

时间窗: 1. Baseline | 2.Post test at 4th week

3.Adherence to task oriented home exercise using Stroke Specific Measure of Adherence .

时间窗: 1. Baseline | 2.Post test at 4th week

次要结局

  • 1.Range of Motion of Arm Movements(2.Voluntary control)

研究者

发起方
KMCH College of Physiotherapy
申办方类型
Other [Private Physiotherapy College ]
责任方
Principal Investigator
主要研究者

Keerthana C

KMCH College of Physiotherapy.The Tamilnadu Dr M G R Medical University

研究点 (1)

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