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临床试验/CTRI/2025/07/090626
CTRI/2025/07/090626尚未招募不适用

Modified Constraint-Induced Movement Therapy with Robotics in Upper Limb Motor Recovery in Persons with Stroke: A Randomized Controlled Trial

All India Institute of Medical Sciences AIIMS Bhubaneswar1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年7月20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
64
试验地点
1
主要终点
Motor recovery: Motor recovery will be assessed with Fugl-Meyer Assessment scale for upper extremity (FMA-UE). The FMA-UE is a widely used scale to assess UE motor impairment. The maximum possible score on the FMA-UE is 66, with higher scores indicating better motor function.

研究概览

简要总结

Stroke is a leading cause of acquired adult disability, with around 80% of persons with stroke suffering from upper limb (UL) motor impairments. Among them, only a small percentage (12%) of persons achieve full arm function following UL rehabilitation training, which highlights the need for further research in this area.

The extent of UL impairment in stroke is one of the independent determinants of basic activities of daily living (ADL), so improving UL motor function is one of the central areas to focus on. Studies have reported many therapeutic techniques for UL training. Among them, two techniques, constraint-induced movement therapy (CIMT) and other robot-assisted movement therapy (RAMT), have demonstrated better outcomes compared to other existing options. Both these techniques aim to improve UL function by the neural plasticity principle through repetitive task-specific training.

It is already well established that robotic training has the capacity to provide a greater number of repetitions in a particular task-specific activity. The robotic training can provide more motivation and keep people engaged in task-specific training.  However, this robotic training has limitations. The task-activity training is being given in an artificial, mechanized environment. Therefore, the improvement achieved during an artificial, mechanized environment may fail to translate into a realistic environment.

Studies have reported that restraining the healthy/less-affected arm during forced-movement training of the impaired arm has a more beneficial effect than forced, repeated use of the impaired UL without restraint. The CIMT training involves restraining the less-impaired UL during most waking hours. Compared to forced-use, the CIMT training causes better white matter integrity. The CIMT training promotes better angiogenesis, nerve regeneration, and nerve function recovery. However, the main disadvantage of CIMT training is that CIMT training cannot precisely control the movement pattern during task-specific activity training and fails to keep the person motivated throughout the training period. In contrast, RA-MT provides continuous training with correct movement patterns and visual stimulation/feedback through exergaming technology, which helps the person to keep engaged in training.

To address the limitations of each technique, we propose a new therapeutic approach, robot-assisted modified constraint movement therapy (RA-mCIMT), which combines the principles of CIMT and RA-MT. This new technique involves structured, functional movement training with the robot instead of therapist-assisted UL training during CIMT therapy for one hour, with the healthy/less impaired UL restrained during the robotic training and most waking time. By combining the strengths of CIMT and RAMT, we assume that RA-mCIMT training will provide better motor recovery than mCIMT in UL following stroke.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
35.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Stroke occurred within six months
  • 1st episode of stroke
  • Age between 35 to 75 years, hemodynamically stable.
  • Mild or no cognitive Deficit (Mini Mental Status Examination (MMSE) score more than 21 points))
  • Presence of minimal voluntary active shoulder (abduction and flexion) and elbow (flexion) (at least 10-20 degree active ROM at shoulder abduction and flexion and elbow movements (10-20 degree active flexion)
  • Presence of spasticity in the elbow flexors of grade one plus (1+) or more in Modified Ashworth scale (MAS).

排除标准

  • Recurrent strokes
  • Presence of neuropathic pain in the affected upper limb
  • Presence of contractures of the affected wrist and fingers
  • Severe spasticity of the affected limb (MAS more than 3)
  • Cognitive dysfunction (Mini Mental Status Examination (MMSE) score less than 21 points)
  • Hemodynamically unstable patients
  • Presence of previous neurological disorder (due to any etiology).

结局指标

主要结局

Motor recovery: Motor recovery will be assessed with Fugl-Meyer Assessment scale for upper extremity (FMA-UE). The FMA-UE is a widely used scale to assess UE motor impairment. The maximum possible score on the FMA-UE is 66, with higher scores indicating better motor function.

时间窗: Assessments will be done at the baseline visit (V0); then at follow-up visits V1, V2, and V3. (V1; 6-7 weeks’ follow-up; V2: 3 months follow-up; V3: 6 months follow-up).

次要结局

  • The Upper Limb function will be assessed with hand-function (HF) domain score of Stroke Impact Scale (SIS) and The Wolf Motor Function Test (WMFT).(Assessments will be done at the baseline visit (V0); then at follow-up visits V1, V2, and V3. (V1; 6-7 weeks’ follow-up; V2: 3 months follow-up; V3: 6 months follow-up).)
  • Quality of life (QoL) will be assessed with SIS scale.(Assessments will be done at the baseline visit (V0); then at follow-up visits V1, V2, and V3. (V1; 6-7 weeks’ follow-up; V2: 3 months follow-up; V3: 6 months follow-up).)
  • Spasticity of Upper Limb will be assessed with modified Ashworth Scale (MAS) at elbow and wrist.(Assessments will be done at the baseline visit (V0); then at follow-up visits V1, V2, and V3. (V1; 6-7 weeks’ follow-up; V2: 3 months follow-up; V3: 6 months follow-up).)

研究者

发起方
All India Institute of Medical Sciences AIIMS Bhubaneswar
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Apurba Barman

All India Institute of Medical Sciences, Bhubaneswar

研究点 (1)

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