Effectiveness of Augmented Reality and Repetitive Transcranial Magnetic Stimulation

Taipei Medical University

Status: Enrolling

Conditions: Stroke

Treatments: Behavioral: Sham rTMS and AR; Behavioral: Conventional physiotherapy; Behavioral: AR; Behavioral: rTMS and AR

Study type: Interventional

Funder types: Other

Identifiers

NCT03750526

N201703084

Details and patient eligibility

About

This study is to investigate the combined effects of repetitive Transcranial Magnetic Stimulation (rTMS) and Augmented Reality (AR) intervention on cortical excitability, balance, gait, activity in individuals with stroke. Forty participants will be recruited in this study. They will be allocated to four group: rTMS and AR group (10), sham rTMS and AR group (10), AR group (10), and conventional physiotherapy group (10).

Full description

Participants will be randomized allocated to four groups: rTMS and AR group, sham rTMS and AR group, AR group ,and conventional physiotherapy group in current study. All participants underwent four weeks, 3 sessions per week, and 60 minutes per session training program. Motor evoked potential (MEP), Time up go test (TUG), Berg Balance Scale (BBS), Fugl-Meyer Assessment (FMA), Multi-directional Reach Test (MDRT),The Postural Assessment Scale for Stroke Patients (PASS), and Taiwanese Depression Questionnaires (TDQ) will be assessed before and after intervention in all participants.

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Cognitive ability is sufficient to understand the nature of study (Mini-Mental State Examination score was above 23).
2. Participants suffer from unilateral hemiplegia caused by a first-ever stroke.
3. Participants are stable in medical and psychological condition.

Exclusion criteria

1. Participants have other neurologic problems that can affect balance and walking ability.
2. Participants take of drugs or have other medical condition that can affect balance and function.
3. Participants have contraindications for rTMS intervention such as pacemaker, cochlear implants, metal in the brain or skull, open wound of brain, or history of epilepsy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 4 patient groups

rTMS and AR group

Experimental group

Description:

Ten participants in group A will undergo repetitive transcranial magnetic stimulation (real, 1 Hz, 15 minutes), follow by a session of augmented reality exercise (45 minutes), 3 days per week for 4 weeks.

Treatment:

Behavioral: rTMS and AR

Sham rTMS and AR group

Active Comparator group

Description:

Ten participants in group B will receive repetitive transcranial magnetic stimulation (sham,1 Hz, 15 minutes), follow by a session of augmented reality exercise (45 minutes), 3 days per week for 4 weeks.

Treatment:

Behavioral: Sham rTMS and AR

AR group

Active Comparator group

Description:

Ten participants in group C will undergo augmented reality exercise 60 minutes a day and 3 days per week for four weeks.

Treatment:

Behavioral: AR

Conventional physiotherapy group

Active Comparator group

Description:

Ten participants allocated to the group D will receive conventional physiotherapy 60 minutes a day and 3 days per week for four weeks.

Treatment:

Behavioral: Conventional physiotherapy