Effectiveness of Interactive Augmented Reality and Electrical Neuromodulation System in Persons With Stroke

Taipei Medical University

Status: Enrolling

Conditions: Stroke

Treatments: Behavioral: Augmented Reality with Functional Electrical Stimulation group; Behavioral: Traditional physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04003571

N201904041

Details and patient eligibility

About

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).

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Augmented reality with functional electrical stimulation group

Experimental group

Description:

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.

Treatment:

Behavioral: Augmented Reality with Functional Electrical Stimulation group

Traditional physiotherapy group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Traditional physiotherapy