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Effectiveness of Robot-assisted Rehabilitation in Persons With Stroke

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ClinicalTrials.gov Identifier: NCT04002076
Recruitment Status : Recruiting
First Posted : June 28, 2019
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
Lai chien hung, Taipei Medical University Hospital

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).

Condition or disease Intervention/treatment Phase
Stroke Behavioral: Robot-assisted hand combined with occupational therapy Behavioral: Traditional occupational therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Robot-assisted Rehabilitation on Upper Limb Function and Neuroplasticity in Persons With Stroke
Actual Study Start Date : August 7, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : February 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: 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.
Behavioral: Robot-assisted hand combined with occupational therapy
Robot-assisted hand group contains 15 minutes of grasp and release motion, 15 minutes of visual feedback training and 30 minutes traditions occupational therapy. Traditional occupational therapy includes cognition training, sensory-motor function therapy, passive ROM exercise, functional hand training, activity of daily living skill training, instruction of using assistive devices,and so on.

Active Comparator: 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.
Behavioral: Traditional occupational therapy
Occupational therapy contains 60 minutes of traditional occupational therapy, which includes cognition training, sensory-motor function therapy, passive ROM exercise, functional hand training, activity of daily living skill training, instruction of using assistive devices,and so on.




Primary Outcome Measures :
  1. 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.


  2. 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 Outcome Measures :
  1. Change of Purdue Pegboard Test (PPT) [ Time Frame: Measurement before and after intervention ( week 0 and at the end of week 6) in both groups ]

    Purdue Pegboard Test is composed of a board with pins, collars and washers. The board contains two parallel rows with 25 holes in each row and the pins, collars and washers are located in cups at the top of the board. Four subtests constitute the Purdue Pegboard test. In the first three the subject has, within 30 seconds, to place the maximum number of pins: first with the dominated hand, then with the other hand and finally with both hands simultaneously (symmetric task). In the last subtest the subject uses alternate hands in order to make assemblies consisting of pins, collars and washers, in a 60-second period.

    The score on the two first pins subtests is the number of pins inserted in the holes. The number of pairs of pins constitutes the score on the third subtest and finally the assembly score consists of the number of pins, collars and washers assembled. Another score is deduced by adding the scores obtained in the first three subtests (right hand + left hand + both hands).


  2. Change of Modified Ashworth Scale (MAS) [ Time Frame: Measurement before and after intervention ( week 0 and at the end of week 6) in both groups ]

    Modified Ashworth scale (MAS) measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. Scoring is recorded as follows:

    0: No increase in muscle tone

    1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the Range of motion (ROM)
    2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
    3. Considerable increase in muscle tone, passive movement difficult
    4. Affected part(s) rigid in flexion or extension

  3. Change of Fugl-Meyer Assessment (FMA)-Upper extremity [ Time Frame: Measurement before and after intervention ( week 0 and at the end of week 6) in both groups ]
    Fugl-Meyer Assessment-Upper extremity is used to measure upper-limb recovery in stroke rehabilitation studies.The scale has 8 items ranging from upper extremity to coordination/speed. Each item further comprises components, with a total of 33. Scoring is done on a 3-point ordinal scale ranges from 0 (no performance) to 2 (faultless performance). The total score range from 0 (no motor function) to 66 (good motor recovery).



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04002076


Contacts
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Contact: Chien-Hung Lai, MD PhD 886-2-27372181 ext 3538 chlai@tmu.edu.tw

Locations
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Taiwan
Taipei Medical university Hospital Recruiting
Taipei, Taiwan
Contact: Chien-Hung Lai, MD PhD         
Sponsors and Collaborators
Taipei Medical University Hospital
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Responsible Party: Lai chien hung, Professor, Taipei Medical University Hospital
ClinicalTrials.gov Identifier: NCT04002076    
Other Study ID Numbers: N201904042
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lai chien hung, Taipei Medical University Hospital:
stroke
Robot-assisted Rehabilitation
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases