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

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.

Study Overview

• Status: Unknown
• Conditions: Stroke
• Intervention / Treatment: Other: Static Standing Table; Device: HIWIN Robotic Gait Training System

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 408
    • Recruiting
    • China Medical University Hospital
    • Contact: Li-Wei Chou, MD, MSc; Phone Number: 2381 +886-4-22052121; Email: chouliwe@gmail.com
    • Principal Investigator: Li-Wei Chou, MD, PhD, MSc
    • Sub-Investigator: Nai-Hsin Meng, MD
    • Sub-Investigator: Andy Chien, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Static Standing Table Training; Patients in this group will receive standard hospital based rehabilitation as well as static standing table training	Other: Static Standing Table; As part of the standard hospital rehabilitation, static standing table allows patient to be in a fully supported standing position
Experimental: Robotic Gait Training; Patients in this group will receive standard hospital based rehabilitation as well as robot-assisted gait rehabilitation training	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Berg Balance Scale	The Berg Balance Scale (or BBS) is a widely used clinical test of a person's static and dynamic balance abilities and is generally considered to be the gold standard for clinical practice	15-20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburgh Sleep Quality Index	The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The questionnaire has been used in many settings, including research and clinical activities, and has been used in the diagnosis of sleep disorders	10-15 minutes
EuroQol five dimensions questionnaire (EQ-5D)	EuroQol five dimensions questionnaire (EQ-5D) is a standardized instrument for measuring generic health status.	10-15 minutes
Resting muscle tone	A device developed by Myoton Technology (Myoton AS, Estonia) will be used to determine the resting muscle tone (oscillation frequency [Hz]) of the tibialis anterior muscle, gastrocnemius muscle, rectus femoris muscle and biceps femoris muscle.	10 minutes
Resting muscle elasticity	A device developed by Myoton Technology (Myoton AS, Estonia) will be used to determine the resting muscle elasticity (Oscillation stiffness [N/m]) of the tibialis anterior muscle, gastrocnemius muscle, rectus femoris muscle and biceps femoris muscle.	10 minutes
Six minute walk test	The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.	6 minutes
Beck's depression Inventory	The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.	7-10 minutes

Collaborators and Investigators

• Sponsor: China Medical University Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Anticipated): April 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: April 21, 2016
• First Submitted That Met QC Criteria: April 26, 2016
• First Posted (Estimate): April 28, 2016

Study Record Updates

• Last Update Posted (Estimate): July 27, 2016
• Last Update Submitted That Met QC Criteria: July 26, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Rehabilitation; Quality of Life; Gait; Robotic
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: CMUH105-REC1-037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will remain confidential and accessible to only the approved researchers