Robot-assisted Gait Training for Patients With Stroke

China Medical University

Status: Unknown

Conditions: Cerebrovascular Accident

Treatments: Procedure: Standard rehab; Device: Robot-assisted gait rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT02781831

HIWIN-CMU-C-105-1

Details and patient eligibility

About

Investigation of the clinical feasibility and efficacy of a newly developed robot-assisted gait training system for stroke survivors. It is anticipated that robot-assisted gait rehabilitation in combination with standard hospital based rehabilitation will achieve significantly better gait outcomes than standard hospital based rehabilitation alone.

Full description

Stroke is the leading cause of permanent disability in most developed countries world wide with one-third of the surviving patients from stroke fail to regain independent walking ability. Robot-assisted gait rehabilitation that is able to deliver high intensity and consistent repeatability in a safe and controlled environment are gaining traction and advocators for its inclusion as part of the routine post-stroke rehabilitation program. However, despite the recent technological advances in the development and design of better robotics, the exact benefit of the robot-assisted therapy over traditional rehabilitation remain sparse and unclear. It is therefore the aim of the proposed project to fulfil this important gap in our clinical knowledge by comparatively investigate the clinical feasibility and efficacy of a recently developed HIWIN Robotic Gait Training System (MRG-P100) against the traditional rehabilitation program with an emphasis on the determination of functional recovery and the appropriate gait adaptation of such robotic system for stroke survivors.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Between the age of 20-65 years;
2. Diagnosis of first, single unilateral cortical-subcortical stroke verified by brain imaging;
3. Paresis of a lower limb;
4. Inability to walk without aid or device.

Exclusion criteria

1. Deemed by a physician to be medically unstable;
2. Other prior musculoskeletal conditions that affected gait capacity;
3. Co-existence of other neurological diseases;
4. Cognitive impairments that would impact on the safe participation in the study (MMSE<23) -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Standard Rehabilitation

Active Comparator group

Description:

Patient with stroke receiving standard hospital based rehabilitation program

Treatment:

Procedure: Standard rehab

Robot-assisted Rehabilitation

Experimental group

Description:

Patient with stroke receiving standard hospital based rehabilitation as well as robot-assisted gait rehabilitation program

Treatment:

Device: Robot-assisted gait rehabilitation