Effectiveness of Robot-assisted Rehabilitation on Upper Limb Function and Neuroplasticity in Persons With Stroke
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change of Box and Block Test (BBT)
Study Overview
Brief Summary
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).
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Mini-Mental State Examination score is above 23
- •A first-ever stroke with unilateral hemiplegia or hemiparesis.
- •Medical and psychological condition is stable.
Exclusion Criteria
- •Balance and walking ability affected by other neurological problems
- •Functional performance affected by medication or medical condition 3 Unable to tolerate rehabilitation.
- •Severe hearing or visual problem.
- •Having pacemaker.
Arms & Interventions
Robot-assisted hand combined with occupational therapy
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.
Intervention: Robot-assisted hand combined with occupational therapy (Behavioral)
Traditional occupational therapy
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.
Intervention: Traditional occupational therapy (Behavioral)
Outcomes
Primary Outcomes
Change of Box and Block Test (BBT)
Time Frame: Measurement before and after intervention ( week 0 and at the end of week 6) in both groups
Box and Block Test is composed of a wooden box divided in two compartments by a partition and 150 blocks. The BBT administration consists of asking the client to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds. The box should be oriented lengthwise and placed at the client's midline, with the compartment holding the blocks oriented towards the hand being tested. In order to practice and register baseline scores, the test should begin with the unaffected upper limb.
Change of Motor evoked potential (MEP)
Time Frame: [Time Frame: Measurement before and after intervention ( week 0 and at the end of week 6) in both groups]
Motor evoked potential (MEP) is recorded from abductor pollicis brevis muscles following direct transcranial magnetic stimulation (TMS) of motor cortex. All TMS is delivered with the participant seated upright on the chair. Both passive and active conditions, participants are instructed to relax their one hand in the seated position. TMS is delivered over the motor cortex (M1) using a concave double cone coil (Magstim Co., United Kingdom) attached to a BiStim magnetic stimulator (Magstim Co., United Kingdom). To locate the optimal site, stimuli are delivered over various points along the M1. The optimal site is the location on the M1 that evoked the greatest MEP amplitude in abductor pollicis brevis muscles. The onset latency and onset to peak amplitude will be assessed.
Secondary Outcomes
- Change of Fugl-Meyer Assessment (FMA)-Upper extremity(Measurement before and after intervention ( week 0 and at the end of week 6) in both groups)
- Change of Purdue Pegboard Test (PPT)(Measurement before and after intervention ( week 0 and at the end of week 6) in both groups)
- Change of Modified Ashworth Scale (MAS)(Measurement before and after intervention ( week 0 and at the end of week 6) in both groups)
Investigators
Lai chien hung
Professor
Taipei Medical University Hospital