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CIMT Versus HABIT in Late Sub-Acute Post-Stroke Rehabilitation (CIMT-HABIT)

2026年6月1日 更新者：Riphah International University

Comparative Effects of Constraint Induced Movement Therapy and Hand-Arm Bimanual Intensive Training for Upper Extremity Function in Late Sub-Acute Post-Stroke Patients

This study will compare the effects of Constraint Induced Movement Therapy and Hand-Arm Bimanual Intensive Training on upper extremity function in late sub-acute post-stroke patients. It will be a randomized controlled trial. Eligible participants will be randomly allocated into two groups. One group will receive Constraint Induced Movement Therapy, while the other group will receive Hand-Arm Bimanual Intensive Training. Both groups will also receive standard physiotherapy for mobility and postural control. The intervention will continue for 3 weeks. Outcomes will be assessed at baseline and after the intervention using upper limb function and motor control assessment tools.

研究概览

地位

主动，不招人

条件

干预/治疗

详细说明

Stroke commonly affects upper extremity function and may reduce a patient's ability to perform daily activities independently. In the late sub-acute phase after stroke, structured rehabilitation may help improve arm and hand function, motor control, and real-world use of the affected upper limb. Constraint Induced Movement Therapy encourages use of the affected upper limb by restricting the unaffected arm and providing intensive task-oriented training. Hand-Arm Bimanual Intensive Training focuses on coordinated use of both hands through functional bimanual tasks. This study will compare these two rehabilitation approaches in late sub-acute post-stroke patients. Findings may help guide evidence-based selection of upper limb rehabilitation strategies for improving functional recovery after stroke.

研究类型

介入性

注册 (估计的)

34

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 巴基斯坦
    • Punjab Province
      • Lahore、Punjab Province、巴基斯坦、55100
        • Riphah College of Rehabilitation Sciences

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

Adults aged 40 years and above.

  • Diagnosed with unilateral ischemic or hemorrhagic stroke.
  • Stroke duration between 3 to 6 months.
  • Mini-Mental State Examination score of 24 or above.
  • Able and willing to provide informed consent.

Exclusion Criteria:

Severe pain in the more affected upper limb on verbal rating scale.

  • Spasticity greater than 3 on the Modified Ashworth Scale in the affected upper limb.
  • Unstable cardiovascular conditions.
  • Any traumatic musculoskeletal injury of the upper limb.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Constraint Induced Movement Therapy Group
Participants in this arm will receive Constraint Induced Movement Therapy for 3 weeks. The unaffected arm will be constrained with a mitt for 90% of waking hours, and the affected arm will receive intensive task-oriented training for 2 hours per day, 5 days per week. Training tasks will include reaching, grasping, manipulating, dressing, and eating activities. Participants will also receive standard physiotherapy for mobility and postural control.
行为的：Constraint Induced Movement Therapy
Constraint Induced Movement Therapy will be provided for 3 weeks. The unaffected upper limb will be constrained with a mitt for 90% of waking hours. Participants will receive intensive task-oriented training of the affected upper limb for 2 hours per day, 5 days per week. Activities will include reaching, grasping, manipulating objects, dressing, and eating tasks. Standard physiotherapy for mobility and postural control will also be provided.
其他名称：
  • CIMT
有源比较器：Hand-Arm Bimanual Intensive Training Group
Participants in this arm will receive Hand-Arm Bimanual Intensive Training for 3 weeks. Training will be provided for 2 hours per day, 5 days per week, using symmetrical and asymmetrical bimanual activities such as folding clothes and pouring water. Participants will also receive standard physiotherapy for mobility and postural control.
行为的：Hand-Arm Bimanual Intensive Training
Hand-Arm Bimanual Intensive Training will be provided for 3 weeks. Participants will receive supervised bimanual upper limb training for 2 hours per day, 5 days per week. Activities will include symmetrical and asymmetrical bilateral tasks such as folding clothes, pouring water, object transfer, and coordinated hand use. Standard physiotherapy for mobility and postural control will also be provided.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
大体时间：Baseline and Week 3 (Post-intervention)
Measures motor recovery and voluntary movement of the affected upper limb after stroke.
Baseline and Week 3 (Post-intervention)
Action Research Arm Test (ARAT)
大体时间：Baseline and Week 3 (Post-intervention)
Assesses upper extremity functional ability including grasp, grip, pinch, and gross movement.
Baseline and Week 3 (Post-intervention)

次要结果测量

结果测量
措施说明
大体时间
Motor Activity Log (MAL)
大体时间：Baseline and Week 3
Evaluates real-world use of the affected arm including Amount of Use and Quality of Movement.
Baseline and Week 3
Box and Block Test (BBT)
大体时间：Baseline and Week 3
Assesses gross manual dexterity by counting blocks transferred within 60 seconds.
Baseline and Week 3
Jebsen-Taylor Hand Function Test (JTHFT)
大体时间：Baseline and Week 3
Measures functional hand performance during simulated daily activities.
Baseline and Week 3
Adult Assisting Hand Assessment (Ad-AHA)
大体时间：Baseline and Week 3
Measures effectiveness of affected hand use during bimanual task performance.
Baseline and Week 3

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Riphah International University

调查人员

  • 学习椅：Ambreen I IQBAL、Riphah International University Role

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年6月5日

初级完成 (估计的)

2026年7月6日

研究完成 (估计的)

2026年8月6日

研究注册日期

首次提交

2026年6月1日

首先提交符合 QC 标准的

2026年6月1日

首次发布 (实际的)

2026年6月4日

研究记录更新

最后更新发布 (实际的)

2026年6月4日

上次提交的符合 QC 标准的更新

2026年6月1日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • HAFSA LATIF

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data will not be shared because no formal data-sharing mechanism or repository has been established for this academic study. Participant confidentiality and privacy will be maintained.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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