Robot-assisted Gait Training for Patients With Stroke

Clinical Feasibility and Efficacy of Robot-assisted Gait Training for Improving Motor Functions in Patients With Stroke

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.

Study Overview

• Status: Unknown
• Conditions: Cerebrovascular Accident
• Intervention / Treatment: Procedure: Standard rehab; Device: Robot-assisted gait rehabilitation

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung City, Taiwan, 404
    • Recruiting
    • China Medical University Hospial
    • Principal Investigator: Nai-Hsin Meng, M.D.
    • Contact: Nai-Hsin Meng, M.D.; Phone Number: 2381 886-4-22052121; Email: nsmeng@ms13.hinet.net
    • Sub-Investigator: Li-Wei Chou, M.D. Ph.D.
    • Sub-Investigator: Pei-Yu Yang, M.D.
    • Sub-Investigator: Andy Chien, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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) -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer Assessment, lower extremity subscale	Lower limb function as measured by Fugl-Meyer Assessment, lower extremity subscale	Assessing change from baseline after 1 month of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Ambulation Categories	Categorizes patients according to basic motor skills necessary for functional ambulation	Assessing change from baseline after 1 month of intervention
10 Meters Walking Test	Assesses walking speed in meters per second over a short duration	Assessing change from baseline after 1 month of intervention
Berg Balance Scale	testing a participant's static and dynamic balance abilities	Assessing change from baseline after 1 month of intervention
Timed Up and Go test	Assess a participant's mobility and requires both static and dynamic balance	Assessing change from baseline after 1 month of intervention
Kinetic and Kinematic Gait Analysis	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.	Assessing change from baseline after 1 month of intervention

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Collaborators: HIWIN Technologies Corporation
• Investigators: Principal Investigator: Nai-Hsin Meng, M.D., China Medical University, China Medical University Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: May 3, 2016
• First Submitted That Met QC Criteria: May 20, 2016
• First Posted (Estimate): May 25, 2016

Study Record Updates

• Last Update Posted (Estimate): July 27, 2016
• Last Update Submitted That Met QC Criteria: July 26, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: HIWIN-CMU-C-105-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED