Development of Interactive Augmented Reality and Electrical Neuromodulation System to Improve Neuroplasticity and Limbs Function in Persons With Stroke
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change of Time Up Go test (TUG)
Study Overview
Brief Summary
This study is to investigate the effects of Augmented Reality (AR) combined with Functional Electrical Stimulation (FES) intervention on cortical excitability, brain structure, lower limbs function, balance, and spasticity in individuals with stroke. Twenty participants will be recruited in this study. They will be allocated to two group: AR and FES group (10), Traditional physiotherapy group (10).
Detailed Description
Participants will be randomized allocated to two groups: Augmented Reality and Functional Electrical Stimulation group , and traditional physiotherapy group. All participants will undergo 60 minutes per session, 3 sessions per week for 8 weeks training. Functional Magnetic Resonance Imaging (fMRI) with Diffusion Tensor Imaging (DTI), Time up go test (TUG), Berg Balance Scale (BBS), Fugl-Meyer Assessment (FMA), Modified Ashworth Scale (MAS), 10 meter walking test will be assessed before and after intervention in all participants.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients present with unilateral hemiplegia caused by a first-ever stroke
- •Brunnstrom stage above stage II, mental health was stable
- •Cognitive ability is sufficient to understand the nature of study (Mini-Mental State Examination score was above 23)
Exclusion Criteria
- •Patients having other neurologic problems, which can affect balance and walking ability
- •Intake of drugs or other medical condition that can affect function or can't tolerate rehabilitation
- •severe hearing or eye problem
Arms & Interventions
Augmented reality with functional electrical stimulation group
Ten participants in group A will undergo 30 minutes interactive augmented reality with functional electrical stimulation intervention and 30 minutes traditional physiotherapy per day, 3 days a week for 8 weeks.
Intervention: Augmented Reality with Functional Electrical Stimulation group (Behavioral)
Traditional physiotherapy group
Ten participants in group B will undergo 30 minutes treadmill and balance training as well as 30 minutes traditional conventional physiotherapy a day, 3 days a week, for 8 weeks.
Intervention: Traditional physiotherapy (Behavioral)
Outcomes
Primary Outcomes
Change of Time Up Go test (TUG)
Time Frame: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
The TUG test will ask participants to stand up, walk for 3 meters, turn, walk back and sit down as fast as they can during the test, and the time requires for each patient to complete the test is recorded.
Change of Berg Balance Scale (BBS)
Time Frame: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
Participants performed a series of 14 functional balance tasks, including maintaining a quiet stance, sitting-to-standing, shifting weight and reaching, turning in place, standing on one leg, and maintaining a tandem stance. Each task was scored on a 5-point ordinal scale (from 0 to 4). A score of 0 denotes the inability of the participant to perform the task, and a score of 4 denotes that the participant can complete the task based on a preset criterion. The highest possible score is 56.
Change of Functional magnetic resonance imaging (fMRI)
Time Frame: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
Our study will use 3 Tesla magnetic resonance imaging\[GE DISCOVERY MR750w system (GE Healthcare, Milwaukee, Wisconsin)\] for functional magnetic resonance imaging. Resting-state functional MRI image is an echo-planar Image (EPI) technique, using a parameter time of repetition of 2500 milliseconds, time of echo is 30 milliseconds, 43 axial slices,slice thickness is 3 mm, flip angle is 80 degrees, field of view is 192 x 192 millimeters, and vixen size is 3 x 3 x 3 millimeters. The EPI scan for 525 seconds. All subjects are asked to close their eyes and supine. our study uses the fractional amplitude of low-frequency fluctuations analysis to confirm abnormal brain function.
Secondary Outcomes
- Change of Modified Ashworth Scale (MAS)(Measurement before and after intervention ( week 0 and at the end of week 8) in both groups)
- Change of Fugl-Meyer Assessment (FMA)-Lower extremity(Measurement before and after intervention ( week 0 and at the end of week 8) in both groups)
- Change of Motor evoked potential (MEP)(Measurement before and after intervention ( week 0 and at the end of week 8) in both groups)
- Change of 10 meter walking test(Measurement before and after intervention ( week 0 and at the end of week 8) in both groups)
- Change of Diffusion Tensor Imaging (DTI)(Measurement before and after intervention ( week 0 and at the end of week 8) in both groups)
Investigators
Lai chien hung
Professor
Taipei Medical University Hospital