The Effectiveness of Occupation-based Bilateral Arm Training on Motor Functions and Activity Participation Among Stroke Survivors During Inpatient Rehabilitation. A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Assessment (FMA)
研究概览
简要总结
People with stroke often experience limitations in motor functions and activity participation. Occupation-based bilateral upper limb training (OBBT) using occupations as meaningful daily activities, and as part of the therapy. The activities in OBBT are tailored to the patient's life with the goal of boosting motivation and engagement to enhance activity performance and participation. This study is a randomized control trial that aims to explore the effect of OBBT along with the conventional therapy in comparison with the conventional therapy alone on motor functions and activity participation among stroke survivors in inpatient rehabilitation setting. This study will be conducted in Qatar Rehabilitation Institute, Hamad Medical Corporation, Doha, Qatar. Participants will be allocated randomly to either the OBBT group or the conventional therapy group. Participants in the OBBT group will receive 30 minutes OBBT program in addition to conventional therapy (90 minutes). Intervention sessions will be conducted 5 times per week over 6 weeks. The participants in the conventional therapy group will receive only the conventional therapy (90 minute). All participants will be assessed using the outcome measure immediately the day after completing the last intervention session at 4th week and 6th week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Data Analyst
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with first ischemic or hemorrhagic stroke by medical physician
- •Stroke onset ≤ 6 months
- •Both males and females with age 18-65 years
- •Cognitive functions within normal and mild deficit (MMSE ≥ 22)
- •With arm and hand upper extremity Brunnstrom stage of >3
- •Free of any other neurological diseases.
排除标准
- •participants with previous stroke
- •musculoskeletal disease or sever pain affecting the upper extremities
- •participant who have taken part in another rehabilitative research
- •sever visual neglect or visual field deficit.
研究组 & 干预措施
OBBT group
Participants in the experimental group will receive face- to- face individual 30 minutes OBBT program in addition to conventional therapy. These 30 -minute OBBT session will be added to the standard conventional therapy sessions (90 minutes).
干预措施: Occupation-Based Bilateral Upper Limb Training (OBBT) (Other)
Conventional Therapy (control group)
Participants in the control group will receive conventional therapy consisting of standard rehabilitation approaches for upper limb impairments.
干预措施: Conventional therapy group (Other)
结局指标
主要结局
Fugl-Meyer Assessment (FMA)
时间窗: At baseline, immediately post 4th weeks, and 6th week of the intervention.
More than 80% of studies use the Fugl-Meyer Assessment, making it the most popular outcome measure for evaluating upper limb motor function recovery after stroke. The assessment consists18 items for the shoulder, elbow, 5 items for the wrist, 7 items for the hand and fingers, and 3 items for upper extremity coordination. The total Fugl-Meyer Assessment (FMA) motor function score for the upper extremity is 66, with higher scores indicating greater motor performance.
Fugl-Meyer Assessment (FMA)
时间窗: At baseline, immediately post 4th weeks, and 6th week of the intervention.
More than 80% of studies use the Fugl-Meyer Assessment, making it the most popular outcome measure for evaluating upper limb motor function recovery after stroke. The assessment consists18 items for the shoulder, elbow, 5 items for the wrist, 7 items for the hand and fingers, and 3 items for upper extremity coordination. The total Fugl-Meyer Assessment (FMA) motor function score for the upper extremity is 66, with higher scores indicating greater motor performance.
次要结局
- Action Research Arm Test (ARAT)(It will be conducted at baseline, immediately post 4th weeks, and 6th week of the intervention.)
- Functional independence measure (FIM)(At baseline, immediately post 4th weeks, and 6th week of the intervention.)
- Stroke Impact Scale (SIS)(At baseline, immediately post 4th weeks, and 6th week of the intervention.)
- Action Research Arm Test (ARAT)(It will be conducted at baseline, immediately post 4th weeks, and 6th week of the intervention.)
- Functional independence measure (FIM)(At baseline, immediately post 4th weeks, and 6th week of the intervention.)
- Stroke Impact Scale (SIS)(At baseline, immediately post 4th weeks, and 6th week of the intervention.)
- Canadian Occupational Performance Measure (COPM)(At baseline, immediately post 4th weeks, and 6th week of the intervention.)