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临床试验/CTRI/2025/07/090116
CTRI/2025/07/090116尚未招募2/3 期

Effectiveness of Occupation based activity training on Functional Task Performance of Upper Extremity and Quality of Life among individuals with Hemiplegic Stroke.

Shreyasi Sarkar1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Chedoke Arm and Hand Inventory (CAHAI)

研究概览

简要总结

The study will begin with the recruitment of participants from NIEPMD and Chettinad Hospital and Research Institute. After providing a detailed explanation of the study, informed consent will be obtained from the participants. All individuals undergo an initial screening process using the Fugl-Meyer Assessment (FMA) Scale. Only participants with moderate to mild upper limb impairment post-stroke (as per FMA scores) are included in the study (n=x). From this, 60 eligible participants will be selected through convenient sampling. These participants will be randomly allocated into two groups: Group A and Group B. Group A will receive a Occupational based activity training intervention. Before the intervention, a baseline assessment using the Chedoke Arm and Hand Inventory (CAHAI) and Stroke Specific- Quality of Life (SS-QOL) will be conducted. Following this, participants in Group A will undergo a 4-week Occupational based activity intervention. After the intervention period, a post-intervention CAHAI and SS-QOL assessment will be performed. Group B will serve as the control group and continue with their usual routine. Similar to Group A, a baseline CAHAI and SS-QOL assessment will be carried out before the intervention period. Participants will then continue their regular routine for the duration of the study, after which a post-intervention CAHAI and SS-QOL assessment will be conducted. Finally, data from both groups will be analyzed using SPSS statistical software to evaluate the outcome of the intervention.

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
40.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Hemiplegic patients with 40-65 years of age.
  • Both male and female genders.
  • Diagnosed with hemiplegic stroke (post-stroke duration more than 3 months) a stage of over 3 in Brunnstrom recovery staging for the affected upper limb Fugl Meyer assessment upper extremity score between of 19 –
  • Modified Ashworth scale score less than 2 in all upper limb muscles.

排除标准

  • Perceptual disorder, Recurrent stroke, Symptomatic cardiac failure, Shoulder dislocation, Uncorrectable vision problems, Patients with other neurological disorder/musculoskeletal problems.

结局指标

主要结局

Chedoke Arm and Hand Inventory (CAHAI)

时间窗: 6 days/week for 4 weeks, 45 minutes/session

Stroke-Specific Quality of Life (SS-QOL) Scale

时间窗: 6 days/week for 4 weeks, 45 minutes/session

次要结局

未报告次要终点

研究者

发起方
Shreyasi Sarkar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Shreyasi Sarkar

Chettinad School of Occupational Therapy

研究点 (1)

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