Effectiveness of Robot-assisted Rehabilitation in Persons With Stroke

Taipei Medical University

Status: Enrolling

Conditions: Stroke

Treatments: Behavioral: Robot-assisted hand combined with occupational therapy; Behavioral: Traditional occupational therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04002076

N201904042

Details and patient eligibility

About

This study is to investigate the effects of robot-assisted hand with visual feedback intervention on cortical excitability, brain structure, spasiticity, gross and fine motor of upper limb and hand in individuals with stroke. Twenty participants will be recruited in this study. They will be allocated to two group: robot-assisted hand combined with traditional occupational therapy group (10), only traditional occupational therapy group (10).

Full description

Participants will be randomized allocated to two groups: robot-assisted hand combined with traditional occupational therapy (OT) group and traditional OT group. All participants underwent six weeks, 3 sessions per week, and 60 minutes per session training program. Motor Evoked Potential (MEP), Fugl-Meyer Assessment (FMA), Modified Ashworth Scale (MAS), Box and Block Test (BBT) and Purdue Pegboard Test (PPT) 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. Mini-Mental State Examination score is above 23
2. A first-ever stroke with unilateral hemiplegia or hemiparesis.
3. Medical and psychological condition is stable.

Exclusion criteria

1. Balance and walking ability affected by other neurological problems

2. Functional performance affected by medication or medical condition 3 Unable to tolerate rehabilitation.

3. Severe hearing or visual problem. 5. Having pacemaker.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Robot-assisted hand combined with occupational therapy

Experimental group

Description:

Ten participants in group A will undergo robot-assisted hand (with visual feedback) combined with occupational therapy. They will receive 60 minutes a day and 3 days a week robot-assisted hand and occupational therapy for six weeks.

Treatment:

Behavioral: Robot-assisted hand combined with occupational therapy

Traditional occupational therapy

Active Comparator group

Description:

Another 10 participants allocated to the group B will receive 60 minutes a day and 3 days a week traditional occupational therapy for six weeks.

Treatment:

Behavioral: Traditional occupational therapy