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

Stroke Clinical Trial

— Walkbot  

Official title:

A Multi-center, Parallel and Randomized Design Clinical Trial of Robot-assisted-gait-training (RAGT) in Stroke Patients to Evaluate Its Efficacy, Safety and Superiority Over Conventional Gait Training

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02694302
• Other study ID #: UMT2013-PS-WB-01
• Status: Completed
• Phase: N/A
• First received: February 18, 2016
• Last updated: September 26, 2016
• Start date: March 2014
• Est. completion date: July 2016

Study information

• Verified date: September 2016
• Source: P&S Mechanics Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

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

Description:

Robot-assisted-gait-training (RAGT) in stroke patients to evaluate its efficacy, safety over conventional gait training.

Experimental group receives robot-assisted-gait-training and conventional gait training.

Active comparator group receives conventional gait training only as the same number as the experimental group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	National Rehabilitation Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
P&S Mechanics Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Ambulation Category(FAC)		9 weeks from baseline	No
Secondary	Motricity Index(MI)		9 weeks from baseline	No
Secondary	10 Meter Walk Test(10MWT)		9 weeks from baseline	No
Secondary	6 Minute Walk Test(6MWT)		9 weeks from baseline	No
Secondary	Medical Research Council(MRC) Scale		9 weeks from baseline	No
Secondary	Modified Ashworth Scale (MAS)		9 weeks from baseline	No
Secondary	Fugl-Meyer Assessment(FMA) of Motor Recovery after Stroke		9 weeks from baseline	No
Secondary	Modified Barthel Index(MBI)		9 weeks from baseline	No
Secondary	National Institutes of Health Stroke Scale (NIHSS)		9 weeks from baseline	No
Secondary	Beck's Depression Inventory test (BDI)		9 weeks from baseline	No
Secondary	Treatment Satisfaction Survey		9 weeks from baseline	No