Clinical Applicability of Robot-assisted Gait Training System in Acute Stroke Patients

NCT ID: NCT02755415

Last Updated: 2016-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2017-12-31

Brief Summary

Investigation of the clinical feasibility and efficacy of a newly developed robot-assisted gait training system for acute stroke survivors. It is anticipated that robot-assisted gait rehabilitation will achieve significantly better gait and quality of life outcomes than the standing table rehabilitation.

Detailed Description

Stroke is not only the second leading cause of mortality in Taiwan, it is also the primary cause of long-term physical and psychological disabilities in our society. Array of reasons have been suggested to be an obstacle for stroke patients to receive adequate physical rehabilitation, including the lack of physical capacity, severe neurological deficits or the loss of strength. Given the critical importance of high-intensity and high-repetitiveness of early rehabilitation for stroke patients in achieving sustainable long term outcomes, robot-assisted gait rehabilitation devices have gained great interest in the last decade and is slowly becoming part of the clinical rehabilitation program for stroke patients. However, despite the growing interest and the significant resources invested for the development of robot-assisted rehabilitation devices, there still lacks empirical evidence of its clinical applicability for stroke patients. Moreover, available evidence to date have mostly focused on sub-acute and chronic stroke patients and investigation in acute stroke population, especially in those with complete incapacitation for ambulation, is sparse. It is therefore the aim of the proposed project to fulfil this significant gap in our clinical knowledge by comparatively investigate the clinical applicability of a recently developed HIWIN Robotic Gait Training System (MRG-P100) against the traditional rehabilitation program with an emphasis on the determination of psychological and functional capacity recovery status in acute stroke survivors.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Static Standing Table Training

Patients in this group will receive standard hospital based rehabilitation as well as static standing table training

Group Type: ACTIVE_COMPARATOR

Static Standing Table

Intervention Type: OTHER

As part of the standard hospital rehabilitation, static standing table allows patient to be in a fully supported standing position

Robotic Gait Training

Patients in this group will receive standard hospital based rehabilitation as well as robot-assisted gait rehabilitation training

Group Type: EXPERIMENTAL

HIWIN Robotic Gait Training System

Intervention Type: DEVICE

HIWIN Robotic Gait Training System is an automatic training system that combines weight-bearing standing, repetitive stepping and gait training

Interventions

HIWIN Robotic Gait Training System

HIWIN Robotic Gait Training System is an automatic training system that combines weight-bearing standing, repetitive stepping and gait training

Intervention Type: DEVICE

Static Standing Table

As part of the standard hospital rehabilitation, static standing table allows patient to be in a fully supported standing position

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Between the age of 20-80 years;
• Diagnosis of first, single unilateral cortical-subcortical acute stroke verified by brain imaging;
• Paresis of a lower limb;
• Ability to walk for only a few meters either with or without aid.

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

China Medical University Hospital

Taichung, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Facility Contacts

Li-Wei Chou, MD, MSc

Role: primary

chouliwe@gmail.com

+886-4-22052121 ext. 2381

Other Identifiers

CMUH105-REC1-037

Identifier Type: -

Identifier Source: org_study_id