Clinical trial NCT02694302: Clinical Trial of Robot-assisted-gait-training (RAGT) in Stroke Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Lead sponsor: P&S Mechanics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-02-29
Enrollment: 91
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional Ambulation Category(FAC)
timeFrame: 9 weeks from baseline
Secondary outcomes:
measure: Motricity Index(MI)
timeFrame: 9 weeks from baseline
measure: 10 Meter Walk Test(10MWT)
timeFrame: 9 weeks from baseline
measure: 6 Minute Walk Test(6MWT)
timeFrame: 9 weeks from baseline
measure: Medical Research Council(MRC) Scale
timeFrame: 9 weeks from baseline
measure: Modified Ashworth Scale (MAS)
timeFrame: 9 weeks from baseline
measure: Fugl-Meyer Assessment(FMA) of Motor Recovery after Stroke
timeFrame: 9 weeks from baseline
measure: Modified Barthel Index(MBI)
timeFrame: 9 weeks from baseline
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: 9 weeks from baseline
measure: Beck's Depression Inventory test (BDI)
timeFrame: 9 weeks from baseline
measure: Treatment Satisfaction Survey
timeFrame: 9 weeks from baseline
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: National Rehabilitation Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: National Rehabilitation Center, Korea
name: Jung Hwan Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: