Comparative Effects of Constraint Induced Movement Therapy and Task-oriented Training on Hand Function in Post Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Nine-Hole Peg Test (NHPT)
研究概览
简要总结
This controlled clinical study investigates and compares the effectiveness of CIMT and TOT in improving hand function among post-stroke patients. A total of 48 participants from hospitals in Sialkot will be randomly divided into two groups and receive a 3-week intervention consisting of 15 sessions. Outcomes will be assessed using the 9-Hole Peg Test, Jebsen-Taylor Hand Function Test, and grip strength, and the data will be analyzed using SPSS-21 under a single-blinded design.
详细描述
This randomized clinical trial will compare the effects of Constraint-Induced Movement Therapy (CIMT) and Task-Oriented Training (TOT) on hand function in post-stroke patients. The study will be conducted over 11 months at Allama Iqbal Memorial Teaching Hospital and Life Care Hospital, Sialkot, with 48 participants (24 per group) recruited through convenience sampling and randomly assigned to either intervention.
Eligible participants will be stroke patients aged 45-65 years in the subacute to chronic phase (>3 months), medically stable, cognitively intact, and with minimal voluntary hand movement, while those with severe neurological, cognitive, or musculoskeletal impairments will be excluded.
Group A will receive CIMT involving restriction of the unaffected limb and intensive task-specific training, while Group B will receive TOT based on functional, task-oriented activities with progressive difficulty. Both interventions will be delivered over 3 weeks (15 sessions).
Outcomes will be measured using the 9-Hole Peg Test, Jebsen-Taylor Hand Function Test, and grip strength assessment. A single-blinded design will be used with blinded outcome assessors, and data will be analyzed using SPSS-21 to compare the effectiveness of both interventions.
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
The outcome assessor was blinded to group allocation to minimize assessment bias during evaluation of hand function outcomes. Participants and therapists were aware of the intervention being administered due to the nature of physiotherapy rehabilitation treatment.
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants will be included if they meet the following criteria:
- •Age between 45 and 65 years
- •Both male and female participants
- •First-ever unilateral ischemic or hemorrhagic stroke confirmed by imaging
- •Stroke onset in subacute to chronic phase (>3 months post-stroke)
- •Medically stable and able to sit independently
- •Voluntary wrist extension of at least 10 degrees and finger extension of at least 10 degrees in the affected hand
- •Mini-Mental State Examination (MMSE) score > 26
- •No significant pain or spasticity in affected upper limb (Modified Ashworth Scale < 2)
- •Adequate sitting balance and trunk control for upper limb activities
- •Willingness and availability to complete the full intervention (3 weeks)
- •No significant musculoskeletal impairments (e.g., fractures or arthritis) affecting the upper limb
排除标准
- •Participants will be excluded if they have:
- •Severe spasticity (Modified Ashworth Scale > 3) or joint contractures
- •Severe aphasia, neglect, or cognitive impairments affecting task performance
- •Recurrent or bilateral stroke
- •Severe upper limb impairment
- •Joint contractures or orthopedic limitations in the upper limb
- •Active infections, skin lesions, or wounds on the upper limb
- •Severe pain during limb movement
- •Participation in other upper limb rehabilitation programs concurrently
研究组 & 干预措施
Constraint-Induced Movement Therapy Group
Participants in this group will receive Constraint-Induced Movement Therapy (CIMT) consisting of restraint of the unaffected upper limb combined with intensive task-specific training and repetitive functional exercises of the affected upper extremity for 3 weeks.
干预措施: Constraint-Induced Movement Therapy (Behavioral)
Task-Oriented Training Group
Participants will receive task-specific upper limb rehabilitation involving functional activities, bilateral tasks, object manipulation, and daily living task practice for 45-60 minutes per session, 5 days per week for 3 weeks.
干预措施: Task-Oriented Training (Behavioral)
结局指标
主要结局
Nine-Hole Peg Test (NHPT)
时间窗: Baseline to 3 weeks
The Nine-Hole Peg Test (9HPT) is a standardized and reliable assessment used to evaluate fine motor dexterity and hand function in individuals with post-stroke impairments. The test requires the participant to place nine pegs into nine holes and then remove them as quickly as possible, with each hand assessed separately. Performance is measured by the time (in seconds) required to complete the task, with shorter completion times indicating better manual dexterity and hand function, while longer times reflect greater impairment.
Jebsen-Taylor Hand Function Test (JHFT)
时间窗: baseline to 3 weeks
The Jebsen-Taylor Hand Function Test (JHFT) is a standardized assessment that takes approximately 15 to 45 minutes to administer and measures everyday fine and gross motor dexterity through seven timed tasks, such as writing, card turning, and object manipulation. Patients complete each task as quickly as possible with one hand at a time while the clinician records the completion time in seconds. Lower execution times indicate superior hand function, providing an efficient way to track pre- and post-treatment recovery or compare performance between limbs
次要结局
未报告次要终点