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

NCT ID: NCT04003571

Last Updated: 2023-01-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-10
• Study Completion Date: 2023-12-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Augmented Reality with Functional Electrical Stimulation group

Intervention Type: BEHAVIORAL

Experimental group contains 30 minutes augmented reality combined with functional electrical stimulation training, and 30 minutes traditional physiotherapy. Augmented reality includes treadmill and balance exercise. Functional electrical stimulation applies on tibialis anterior muscle. Traditional physiotherapy includes rolling, sitting, standing, overground walking, facilitation of the paretic limbs, and so on.

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.

Group Type: ACTIVE_COMPARATOR

Traditional physiotherapy

Intervention Type: BEHAVIORAL

Traditional physiotherapy includes treadmill and balance training for 30 minutes as well as rolling, sitting, standing, overground walking, facilitation of the paretic limbs for another 30 minutes .

Interventions

Augmented Reality with Functional Electrical Stimulation group

Experimental group contains 30 minutes augmented reality combined with functional electrical stimulation training, and 30 minutes traditional physiotherapy. Augmented reality includes treadmill and balance exercise. Functional electrical stimulation applies on tibialis anterior muscle. Traditional physiotherapy includes rolling, sitting, standing, overground walking, facilitation of the paretic limbs, and so on.

Intervention Type: BEHAVIORAL

Traditional physiotherapy

Traditional physiotherapy includes treadmill and balance training for 30 minutes as well as rolling, sitting, standing, overground walking, facilitation of the paretic limbs for another 30 minutes .

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lai chien hung

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Taipei Medical university Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Chien-Hung Lai, MD PhD

Role: CONTACT

chlai@tmu.edu.tw

886-2-27372181 ext. 3538

Facility Contacts

Chien-Hung Lai, MD PhD

Role: primary

Other Identifiers

N201904041

Identifier Type: -

Identifier Source: org_study_id