Clinical trial NCT03750526: Effectiveness of Augmented Reality and Repetitive Transcranial Magnetic Stimulation
Official title: Investigate the Effectiveness of Augmented Reality and Repetitive Transcranial Magnetic Stimulation Technology in Persons With Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Repetitive transcranial magnetic stimulation (rTMS)
Augmented reality (AR)
stroke
Lead sponsor: Taipei Medical University Hospital
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 40
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 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of Time Up Go test (TUG)
timeFrame: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
Secondary outcomes:
measure: Change of Berg Balance Scale (BBS)
timeFrame: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
measure: Change of Motor evoked potential (MEP)
timeFrame: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
measure: Change of Fugl-Meyer Assessment (FMA)-Lower extremity
timeFrame: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
measure: Change of Multi-directional Reach Test (MDRT)
timeFrame: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
measure: Change of The Postural Assessment Scale for Stroke Patients (PASS)
timeFrame: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
measure: Change of Taiwanese Depression Questionnaires (TDQ)
timeFrame: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical university Hospital
Study officials:
affiliation: Taipei Medical University Hospital
name: Chien-Hung Lai, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: