Clinical trial NCT02781831: Robot-assisted Gait Training for Patients With Stroke
Official title: Clinical Feasibility and Efficacy of Robot-assisted Gait Training for Improving Motor Functions in Patients With Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebrovascular Accident
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: HIWIN Technologies Corporation
First posted: 2016-05-25
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigation of the clinical feasibility and efficacy of a newly developed robot-assisted gait training system for stroke survivors. It is anticipated that robot-assisted gait rehabilitation in combination with standard hospital based rehabilitation will achieve significantly better gait outcomes than standard hospital based rehabilitation alone.

Detailed description: Stroke is the leading cause of permanent disability in most developed countries world wide with one-third of the surviving patients from stroke fail to regain independent walking ability. Robot-assisted gait rehabilitation that is able to deliver high intensity and consistent repeatability in a safe and controlled environment are gaining traction and advocators for its inclusion as part of the routine post-stroke rehabilitation program. However, despite the recent technological advances in the development and design of better robotics, the exact benefit of the robot-assisted therapy over traditional rehabilitation remain sparse and unclear. It is therefore the aim of the proposed project to fulfil this important gap in our clinical knowledge by comparatively investigate the clinical feasibility and efficacy of a recently developed HIWIN Robotic Gait Training System (MRG-P100) against the traditional rehabilitation program with an emphasis on the determination of functional recovery and the appropriate gait adaptation of such robotic system for stroke survivors.

Eligibility criteria: Inclusion Criteria:

1. Between the age of 20-65 years;
2. Diagnosis of first, single unilateral cortical-subcortical stroke verified by brain imaging;
3. Paresis of a lower limb;
4. Inability to walk without aid or device.

Exclusion Criteria:

1. Deemed by a physician to be medically unstable;
2. Other prior musculoskeletal conditions that affected gait capacity;
3. Co-existence of other neurological diseases;
4. Cognitive impairments that would impact on the safe participation in the study (MMSE\<23) -

Primary outcomes:
measure: Fugl-Meyer Assessment, lower extremity subscale
timeFrame: Assessing change from baseline after 1 month of intervention
Secondary outcomes:
measure: Functional Ambulation Categories
timeFrame: Assessing change from baseline after 1 month of intervention
measure: 10 Meters Walking Test
timeFrame: Assessing change from baseline after 1 month of intervention
measure: Berg Balance Scale
timeFrame: Assessing change from baseline after 1 month of intervention
measure: Timed Up and Go test
timeFrame: Assessing change from baseline after 1 month of intervention
measure: Kinetic and Kinematic Gait Analysis
timeFrame: Assessing change from baseline after 1 month of intervention
Other outcomes:
Locations:
city: Taichung City
country: Taiwan
facility: China Medical University Hospial
Study officials:
affiliation: China Medical University, China Medical University Hospital
name: Nai-Hsin Meng, M.D.
role: PRINCIPAL_INVESTIGATOR
References: