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

China Medical University

Status

Unknown

Conditions

Stroke

Treatments

Device: HIWIN Robotic Gait Training System

Other: Static Standing Table

Study type

Interventional

Funder types

Other

Identifiers

NCT02755415

CMUH105-REC1-037

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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)