Robot-assisted Gait Training for Patients With Stroke

NCT02781831 | Unknown

• 1 other identifier: HIWIN-CMU-C-105-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Accident

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Functional Ambulation Categories

  Assessing change from baseline after 1 month of intervention

• 10 Meters Walking Test

  Assessing change from baseline after 1 month of intervention

• Berg Balance Scale

  Assessing change from baseline after 1 month of intervention

• Timed Up and Go test

  Assessing change from baseline after 1 month of intervention

• Kinetic and Kinematic Gait Analysis

  Assessing change from baseline after 1 month of intervention

Study Arms (2)

Standard Rehabilitation

ACTIVE COMPARATOR

Patient with stroke receiving standard hospital based rehabilitation program

Procedure: Standard rehab

Robot-assisted Rehabilitation

EXPERIMENTAL

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

Device: Robot-assisted gait rehabilitation

Interventions

Standard rehab PROCEDURE

Standard hospital based rehabilitation for patients with stroke

Standard Rehabilitation

Robot-assisted gait rehabilitation DEVICE

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

Robot-assisted Rehabilitation

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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) -

Sponsors & Collaborators

• China Medical University Hospital: lead
• HIWIN Technologies Corporation: collaborator

Study Sites (1)

China Medical University Hospial

Taichung, Taiwan, 404, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nai-Hsin Meng, M.D.

  China Medical University, China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nai-Hsin Meng, M.D.

CONTACT

886-4-22052121; nsmeng@ms13.hinet.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 25, 2016
• Study Start: May 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: July 27, 2016

Record last verified: 2016-07

Locations

TW (1)