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Robot-assisted Gait Training for Patients With Stroke

Primary Purpose

Cerebrovascular Accident

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Standard rehab
Robot-assisted gait rehabilitation
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Accident

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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) -

Sites / Locations

  • China Medical University HospialRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Rehabilitation

Robot-assisted Rehabilitation

Arm Description

Patient with stroke receiving standard hospital based rehabilitation program

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Functional Ambulation Categories
Categorizes patients according to basic motor skills necessary for functional ambulation
10 Meters Walking Test
Assesses walking speed in meters per second over a short duration
Berg Balance Scale
testing a participant's static and dynamic balance abilities
Timed Up and Go test
Assess a participant's mobility and requires both static and dynamic balance
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.

Full Information

First Posted
May 3, 2016
Last Updated
July 26, 2016
Sponsor
China Medical University Hospital
Collaborators
HIWIN Technologies Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02781831
Brief Title
Robot-assisted Gait Training for Patients With Stroke
Official Title
Clinical Feasibility and Efficacy of Robot-assisted Gait Training for Improving Motor Functions in Patients With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital
Collaborators
HIWIN Technologies Corporation

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Rehabilitation
Arm Type
Active Comparator
Arm Description
Patient with stroke receiving standard hospital based rehabilitation program
Arm Title
Robot-assisted Rehabilitation
Arm Type
Experimental
Arm Description
Patient with stroke receiving standard hospital based rehabilitation as well as robot-assisted gait rehabilitation program
Intervention Type
Procedure
Intervention Name(s)
Standard rehab
Intervention Description
Standard hospital based rehabilitation for patients with stroke
Intervention Type
Device
Intervention Name(s)
Robot-assisted gait rehabilitation
Intervention Description
An extra 30 minutes of robot-assisted gait rehabilitation after receiving standard hospital based rehabilitation for patients with stroke
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment, lower extremity subscale
Description
Lower limb function as measured by Fugl-Meyer Assessment, lower extremity subscale
Time Frame
Assessing change from baseline after 1 month of intervention
Secondary Outcome Measure Information:
Title
Functional Ambulation Categories
Description
Categorizes patients according to basic motor skills necessary for functional ambulation
Time Frame
Assessing change from baseline after 1 month of intervention
Title
10 Meters Walking Test
Description
Assesses walking speed in meters per second over a short duration
Time Frame
Assessing change from baseline after 1 month of intervention
Title
Berg Balance Scale
Description
testing a participant's static and dynamic balance abilities
Time Frame
Assessing change from baseline after 1 month of intervention
Title
Timed Up and Go test
Description
Assess a participant's mobility and requires both static and dynamic balance
Time Frame
Assessing change from baseline after 1 month of intervention
Title
Kinetic and Kinematic Gait Analysis
Description
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.
Time Frame
Assessing change from baseline after 1 month of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Between the age of 20-65 years; Diagnosis of first, single unilateral cortical-subcortical stroke verified by brain imaging; Paresis of a lower limb; Inability to walk without aid or device. Exclusion Criteria: Deemed by a physician to be medically unstable; Other prior musculoskeletal conditions that affected gait capacity; Co-existence of other neurological diseases; Cognitive impairments that would impact on the safe participation in the study (MMSE<23) -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nai-Hsin Meng, M.D.
Phone
886-4-22052121
Ext
2381
Email
nsmeng@ms13.hinet.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nai-Hsin Meng, M.D.
Organizational Affiliation
China Medical University, China Medical University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
China Medical University Hospial
City
Taichung City
ZIP/Postal Code
404
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nai-Hsin Meng, M.D.
Phone
886-4-22052121
Ext
2381
Email
nsmeng@ms13.hinet.net
First Name & Middle Initial & Last Name & Degree
Nai-Hsin Meng, M.D.
First Name & Middle Initial & Last Name & Degree
Andy Chien, Ph.D.
First Name & Middle Initial & Last Name & Degree
Li-Wei Chou, M.D. Ph.D.
First Name & Middle Initial & Last Name & Degree
Pei-Yu Yang, M.D.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Robot-assisted Gait Training for Patients With Stroke

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