Robot-assisted Gait Training for Patients With Stroke

Cerebrovascular Accident Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02781831
• Other study ID #: HIWIN-CMU-C-105-1
• Status: Recruiting
• Phase: N/A
• First received: May 3, 2016
• Last updated: July 26, 2016
• Start date: May 2016
• Est. completion date: December 2018

Study information

• Verified date: July 2016
• Source: China Medical University Hospital
• Contact: Nai-Hsin Meng, M.D.
• Phone: 886-4-22052121
• Email: nsmeng[@]ms13.hinet.net
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

Procedure:
• Standard rehab
Standard hospital based rehabilitation for patients with stroke

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

Locations

Country	Name	City	State
Taiwan	China Medical University Hospial	Taichung City

Sponsors (2)

Lead Sponsor	Collaborator
China Medical University Hospital	HIWIN Technologies Corporation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Functional Ambulation Categories	Categorizes patients according to basic motor skills necessary for functional ambulation	Assessing change from baseline after 1 month of intervention	No
Secondary	10 Meters Walking Test	Assesses walking speed in meters per second over a short duration	Assessing change from baseline after 1 month of intervention	No
Secondary	Berg Balance Scale	testing a participant's static and dynamic balance abilities	Assessing change from baseline after 1 month of intervention	No
Secondary	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	No
Secondary	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	No