Clinical trial NCT04003571: Effectiveness of Interactive Augmented Reality and Electrical Neuromodulation System in Persons With Stroke
Official title: Development of Interactive Augmented Reality and Electrical Neuromodulation System to Improve Neuroplasticity and Limbs Function in Persons With Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: stroke
augmented reality
functional electrical stimulation
Lead sponsor: Taipei Medical University Hospital
Sponsor class: OTHER
First posted: 2019-07-01
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Patients present with unilateral hemiplegia caused by a first-ever stroke
2. Brunnstrom stage above stage II, mental health was stable
3. Cognitive ability is sufficient to understand the nature of study (Mini-Mental State Examination score was above 23)

Exclusion Criteria:

1. Patients having other neurologic problems, which can affect balance and walking ability
2. Intake of drugs or other medical condition that can affect function or can't tolerate rehabilitation
3. severe hearing or eye problem

Primary outcomes:
measure: Change of Time Up Go test (TUG)
timeFrame: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
measure: Change of Berg Balance Scale (BBS)
timeFrame: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
measure: Change of Functional magnetic resonance imaging (fMRI)
timeFrame: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
Secondary outcomes:
measure: Change of Fugl-Meyer Assessment (FMA)-Lower extremity
timeFrame: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
measure: Change of Modified Ashworth Scale (MAS)
timeFrame: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
measure: Change of Motor evoked potential (MEP)
timeFrame: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
measure: Change of 10 meter walking test
timeFrame: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
measure: Change of Diffusion Tensor Imaging (DTI)
timeFrame: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical university Hospital
Study officials:
References: