Robot-assisted Gait Training for Patients With Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cerebrovascular Accident

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard Rehabilitation

Patient with stroke receiving standard hospital based rehabilitation program

Group Type ACTIVE_COMPARATOR

Standard rehab

Intervention Type PROCEDURE

Standard hospital based rehabilitation for patients with stroke

Robot-assisted Rehabilitation

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

Group Type EXPERIMENTAL

Robot-assisted gait rehabilitation

Intervention Type DEVICE

An extra 30 minutes of robot-assisted gait rehabilitation after receiving standard hospital based rehabilitation for patients with stroke

Interventions

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Standard rehab

Standard hospital based rehabilitation for patients with stroke

Intervention Type PROCEDURE

Robot-assisted gait rehabilitation

An extra 30 minutes of robot-assisted gait rehabilitation after receiving standard hospital based rehabilitation for patients with stroke

Intervention Type DEVICE

Eligibility Criteria

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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) -

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No