Clinical Trial of Robot-assisted-gait-training (RAGT) in Stroke Patients

NCT02694302 | Completed

• 1 other identifier: UMT2013-PS-WB-01
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 2

Brief Summary

A clinical trial of robot-assisted-gait-training (RAGT) in stroke patients to evaluate its efficacy, safety over conventional gait training.

Conditions

Stroke

Keywords

Stroke

Outcome Measures

Primary Outcomes (1)

• Functional Ambulation Category(FAC)

  9 weeks from baseline

Secondary Outcomes (10)

• Motricity Index(MI)

  9 weeks from baseline

• 10 Meter Walk Test(10MWT)

  9 weeks from baseline

• 6 Minute Walk Test(6MWT)

  9 weeks from baseline

• Medical Research Council(MRC) Scale

  9 weeks from baseline

• Modified Ashworth Scale (MAS)

  9 weeks from baseline

Study Arms (2)

Walkbot

EXPERIMENTAL

Walkbot(robot assisted gait training) 30 minutes and conventional physical therapy 30 minutes each per day to be administered 5 times a week for 3 weeks.

Device: Walkbot; Device: Conventional physical therapy

Conventional physical therapy

ACTIVE COMPARATOR

Conventional physical therapy 30 minutes to be administered twice a day, 5 times a week for 3 weeks.

Device: Conventional physical therapy

Interventions

Walkbot DEVICE

Walkbot(robot assisted gait training) 30 minutes and conventional physical therapy 30 minutes each per day to be administered 5 times a week for 3 weeks.

Walkbot

Conventional physical therapy DEVICE

Conventional physical therapy 30 minutes to be administered twice a day, 5 times a week for 3 weeks.

Conventional physical therapy; Walkbot

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age more than 19 and under 80
• Weight under 100kg
• Height less than 200cm
• Able to walk independently before onset of stroke
• Ischemic or hemorrhagic stroke patients
• Patients with motor paralysis and gait disturbance after stroke and seeking rehabilitation treatment
• FAC(Functional Ambulation Category) under 3 (0\~2)
• Subacute stroke patients after 3 days and before 3 months of onset
• Be informed of the nature of the study and agreed on written consent voluntarily
• Patients taking medications or scheduled medications due to stroke

You may not qualify if:

• Patients with contraindications to weight bearing such as fractures, etc.
• Uncontrolled stage 2 hypertension (systolic over 160 mmHg or diastolic more than 100mmHg) or with uncontrolled orthostatic hypotension
• Patients with cardiopulmonary disease or other underlying diseases that can not tolerate gait training
• Patients with severe skin damage and bedsore on wearing part of the trial device
• Pregnant or breast-feeding
• Participation within 30 days of the other clinical trials
• Patients whom the investigator considers inappropriate to participate in the study

Sponsors & Collaborators

• P&S Mechanics Co., Ltd.: lead

Study Sites (2)

National Rehabilitation Center

Seoul, 01022, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Jung Hwan Kim, MD, PhD

  National Rehabilitation Center, Korea

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: February 29, 2016
• Study Start: March 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 27, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)