跳至主要内容
临床试验/CTRI/2025/08/093462
CTRI/2025/08/093462尚未招募不适用

Effect of 4 weeks of Task-Based Mirror Therapy Versus Movement-Based Mirror Therapy on Lower Limb Function and Balance in Individuals with Sub-acute Stroke: An Experimental Study.

K. J. Somaiya College of Physiotherapy1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年9月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
42
试验地点
1
主要终点
1.Fugl-Meyer Assessment-Lower EXtremity

研究概览

简要总结

The study will be conducted after obtaining approval from the Institutional Ethics Committee (IEC), and all participants will provide written informed consent prior to enrollment. This experimental study will recruit 42 individuals with sub-acute stroke who meet the inclusion and exclusion criteria. Participants will be randomly allocated into two equal groups: Task-Based Mirror Therapy (TMT) group and Movement-Based Mirror Therapy (MMT) group.Outcome Measures: Primary outcome measure: Fugl-Meyer Assessment for the Lower Extremity (FMA-LE) for motor function, Berg Balance Scale (BBS) for balance and Timed Up and Go (TUG) test for functional mobility.

Procedure: All participants will undergo pre-assessment for demographic data, medical history, and baseline values of FMA-LE, BBS, and TUG.

TMT Group: Will perform functional, goal-directed lower limb tasks (ball rolling forward/backward and sideways, rocker board exercises, pushing a pillow in multiple directions, picking and releasing pegs, wiping the floor, and placing the foot on floor markers) in front of a mirror. Each task will be performed for 2 sets of 10 repetitions with short rest intervals, and the dosage will be progressively increased based on individual tolerance.

MMT Group: Will perform repetitive, isolated lower limb movements (ankle dorsiflexion–plantarflexion, knee flexion–extension, hip abduction–adduction) in front of a mirror. Each movement will be performed for 2 sets of 10 repetitions with short rest intervals, and dosage will be progressively increased as tolerated.

Both groups will receive their assigned mirror therapy intervention in addition to conventional physiotherapy, delivered three days per week. Each session will include 30–35 minutes of standard physiotherapy combined with the allocated mirror therapy, for a total intervention period of four weeks.

Post-assessment: At the end of the four-week intervention, FMA-LE, BBS, and TUG will be reassessed.

Data Analysis: Data will be analyzed using Statistical Package for the Social Sciences (SPSS) software. Descriptive statistics will be used to summarize demographic and baseline characteristics. Paired t-tests or Wilcoxon signed-rank tests will be used for within-group comparisons, and independent t-tests or Mann–Whitney U tests will be used for between-group comparisons, with the level of significance set at p < 0.05.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 59.00 Year(s)(—)
性别
All

入选标准

  • Individuals aged 18 to 59 years
  • Experiencing a first-ever unilateral stroke
  • Currently in the sub-acute phase of stroke recovery, defined as between 8 days and 6 months.
  • 4.Individuals demonstrating adequate cognitive function, as evidenced by a Mini-Mental State Examination (MMSE) score more than or equal to 24 5.Exhibiting a Voluntary Control Assessment (VCA) grade for ankle more than or equal to 3
  • Functional Ambulation Category grade more than or equal to 2.

排除标准

  • Individuals with lower limb impairment caused by other diseases or musculoskeletal diseases.
  • Individuals diagnosed with psychiatric conditions
  • Individuals with diagnosed perceptual deficits and visual deficits (unilateral neglect, hemianopsia or apraxia)
  • Complete sensory loss (superficial and deep sensations).

结局指标

主要结局

1.Fugl-Meyer Assessment-Lower EXtremity

时间窗: 1. Pre-treatment assessment | 2. Post-treatment assessment at 4 weeks

2.Bergs Balance Scale

时间窗: 1. Pre-treatment assessment | 2. Post-treatment assessment at 4 weeks

3.Timed Up and Go Test

时间窗: 1. Pre-treatment assessment | 2. Post-treatment assessment at 4 weeks

次要结局

未报告次要终点

研究者

发起方
K. J. Somaiya College of Physiotherapy
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Anushka Ajit Tambe PT

KJ Somaiya College of Physiotherapy

研究点 (1)

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