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临床试验/CTRI/2025/04/084305
CTRI/2025/04/084305尚未招募不适用

Effectiveness of Gravity supported, Computer enhanced Exoskeleton to Promote Recovery of Upper Limb Function for Patients after Stroke “ A randomized control study

Fluid Research Grant, CMC Vellore1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年4月21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
52
试验地点
1
主要终点
-The Upper extremity subscale of the Motricity Index (MI arm)

研究概览

简要总结

Recovery of the impaired upper limb is a crucial felt need and priority for these patients. Hemiparetic upper limb rehabilitation usually focus on compensatory strategies that use the intact upper limb to compensate for the impaired upper limb. With the understanding of neuroplasticity after acquired brain  injury, several new therapies such as  conventional occupational therapy methods, constraint-induced movement therapy (CIMT),  mirror therapy, functional electrical stimulation, mental practice and  virtual reality augmentation  focus on improving the neurologic recovery of the impaired upper limb.

Recently, robot-assisted therapy (RAT), a technology-based rehabilitation approach, which offers high-intensity, highly repetitive, task-specific UL training with real-time  feedback has been reported as an effective strategy in UL rehabilitation. The ArmeoSpring is a passive instrumented arm orthosis with a spring mechanism for adjustable arm weight support in a 3D workspace, and is helpful for patients who have restricted functions in their upper extremities due to various neurological disorders. Partial relief of the upper limb’s weight and mechanical-assisted therapy in a virtual workspace enables the  patient to produce a larger ROM within a 3-dimensional workspace. This enables repetitive and active exertion of goal-directed movements, with enlarged ROM  during the practice of complex motor tasks in an enriched learning environment.

In this randomized controlled study, we aim to study the effectiveness of technology enhanced rehabilitation of the upper limb using Armeospring  in sub acute and chronic  stroke patients who have been admitted for inpatien rehabilitation. Patients will be randomized to two groups. The intervention group will receive  ten technology enabled  upper limb training sessions using a gravity supported computer enhanced exoskeleton( Armeospring), while the control group will receive ten sessions of gravity eliminated exercises for the upper limb in the form of horizontal and vertical reach activities, with the exoskeleton fitted, but without activating the technology.  Both groups will also receive the standard conventional therapy. Both the patient and assessors will be blinded to the intervention. Pre and post-exposure, various motor and functional outcome measures will be assessed and analyzed statistically.  The outcomes   will be compared between those with subacute stroke vs chronic stroke, age<40 years vs > 40 years and mild upper extremity impairment vs moderate to severe impairment. The study will also compare the outcomes in patients who receive 10 sessions of Armeospring and a subset of patients who receive 20 sessions of therapy using Armeospring. The perception of patients undergoing treatment with Armeospring will also be studied using the  Patient Global perception of change score.

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
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients with history of cerebrovascular accident -Admitted for rehabilitation for a minimum duration of 6 weeks.-Clinical and radiological diagnosis of Ischemic / Haemorrhagic strok,1 month to 2 years after stroke,First episode of stroke,Severe to mild unilateral upper limb paresis of the dominant or non dominant UE,Patients with mild or no cognitive deficit ,Able to sit for 1 hour.

排除标准

  • Significant impairment in the vision,Unstable medical conditions,Severe neuropathic pain,Severe spasticity ,Contracture or in the affected UL, coexisting neurological illnesses, Prior botulinum toxin injections , previously participated in robotic therapy in the upper extremities, Pregnant women.

结局指标

主要结局

-The Upper extremity subscale of the Motricity Index (MI arm)

时间窗: Intervention-Baseline,2weeks,1 month, 3month | Control- Baseline,2weeks,1 month, 6 weeks, 3month

-Motor Domain Scale of Fugl Meyer Upper Extremity scale

时间窗: Intervention-Baseline,2weeks,1 month, 3month | Control- Baseline,2weeks,1 month, 6 weeks, 3month

-Action Research Arm test (ARAT)

时间窗: Intervention-Baseline,2weeks,1 month, 3month | Control- Baseline,2weeks,1 month, 6 weeks, 3month

-Armeospring measures- AROM, AMove

时间窗: Intervention-Baseline,2weeks,1 month, 3month | Control- Baseline,2weeks,1 month, 6 weeks, 3month

次要结局

  • --Modified Barthel Index(-Modified Ashworth Scale)

研究者

发起方
Fluid Research Grant, CMC Vellore
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Vijay Sivaraj

Christian Medical College, Vellore

研究点 (1)

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