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Robot-assisted Gait Training for Patients With Stroke

Sponsor
China Medical University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02781831
Collaborator
HIWIN Technologies Corporation (Other)
60
Enrollment
1
Location
2
Arms
31
Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Standard rehab
  • Device: Robot-assisted gait rehabilitation
 N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Clinical Feasibility and Efficacy of Robot-assisted Gait Training for Improving Motor Functions in Patients With Stroke
Study Start Date :
May 1, 2016
Anticipated Primary Completion Date :
Jun 1, 2018
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Standard Rehabilitation

Patient with stroke receiving standard hospital based rehabilitation program

Procedure: Standard rehab
Standard hospital based rehabilitation for patients with stroke
Experimental: Robot-assisted Rehabilitation

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

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

Outcome Measures

Primary Outcome Measures

  1. Fugl-Meyer Assessment, lower extremity subscale [Assessing change from baseline after 1 month of intervention]

    Lower limb function as measured by Fugl-Meyer Assessment, lower extremity subscale

Secondary Outcome Measures

  1. Functional Ambulation Categories [Assessing change from baseline after 1 month of intervention]

    Categorizes patients according to basic motor skills necessary for functional ambulation

  2. 10 Meters Walking Test [Assessing change from baseline after 1 month of intervention]

    Assesses walking speed in meters per second over a short duration

  3. Berg Balance Scale [Assessing change from baseline after 1 month of intervention]

    testing a participant's static and dynamic balance abilities

  4. Timed Up and Go test [Assessing change from baseline after 1 month of intervention]

    Assess a participant's mobility and requires both static and dynamic balance

  5. Kinetic and Kinematic Gait Analysis [Assessing change from baseline after 1 month of intervention]

    The temporo-spatial and kinematic gait parameters of the participants will be assessed using a Vicon Motion Analysis System with kinetic data collection through a force plate.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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) -

Contacts and Locations

Locations

Site City State Country Postal Code
1 China Medical University Hospial Taichung City Taiwan 404

Sponsors and Collaborators

  • China Medical University Hospital
  • HIWIN Technologies Corporation

Investigators

  • Principal Investigator: Nai-Hsin Meng, M.D., China Medical University, China Medical University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT02781831
Other Study ID Numbers:
  • HIWIN-CMU-C-105-1
First Posted:
May 25, 2016
Last Update Posted:
Jul 27, 2016
Last Verified:
Jul 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Additional relevant MeSH terms:
Stroke

Study Results

No Results Posted as of Jul 27, 2016