Effectiveness of Robot-assisted Rehabilitation in Persons With Stroke
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Robot-assisted hand combined with occupational therapy
Traditional occupational therapy
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, Robot-assisted Rehabilitation
Eligibility Criteria
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.
4. Severe hearing or visual problem. 5. Having pacemaker.
Sites / Locations
- Taipei Medical university HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Robot-assisted hand combined with occupational therapy
Traditional occupational therapy
Arm 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.
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.
Outcomes
Primary Outcome Measures
Change of Box and Block Test (BBT)
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)
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
Change of Purdue Pegboard Test (PPT)
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).
Change of Modified Ashworth Scale (MAS)
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
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)
More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
Considerable increase in muscle tone, passive movement difficult
Affected part(s) rigid in flexion or extension
Change of Fugl-Meyer Assessment (FMA)-Upper extremity
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).
Full Information
NCT ID
NCT04002076
First Posted
June 27, 2019
Last Updated
January 28, 2023
Sponsor
Taipei Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04002076
Brief Title
Effectiveness of Robot-assisted Rehabilitation in Persons With Stroke
Official Title
Effectiveness of Robot-assisted Rehabilitation on Upper Limb Function and Neuroplasticity in Persons With Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 7, 2019 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, Robot-assisted Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Robot-assisted hand combined with occupational therapy
Arm Type
Experimental
Arm 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.
Arm Title
Traditional occupational therapy
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Robot-assisted hand combined with occupational therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Traditional occupational therapy
Intervention Description
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 Measure Information:
Title
Change of Box and Block Test (BBT)
Description
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.
Time Frame
Measurement before and after intervention ( week 0 and at the end of week 6) in both groups
Title
Change of Motor evoked potential (MEP)
Description
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.
Time Frame
[Time Frame: Measurement before and after intervention ( week 0 and at the end of week 6) in both groups]
Secondary Outcome Measure Information:
Title
Change of Purdue Pegboard Test (PPT)
Description
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).
Time Frame
Measurement before and after intervention ( week 0 and at the end of week 6) in both groups
Title
Change of Modified Ashworth Scale (MAS)
Description
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
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)
More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
Considerable increase in muscle tone, passive movement difficult
Affected part(s) rigid in flexion or extension
Time Frame
Measurement before and after intervention ( week 0 and at the end of week 6) in both groups
Title
Change of Fugl-Meyer Assessment (FMA)-Upper extremity
Description
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).
Time Frame
Measurement before and after intervention ( week 0 and at the end of week 6) in both groups
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
4. Severe hearing or visual problem. 5. Having pacemaker.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chien-Hung Lai, MD PhD
Phone
886-2-27372181
Ext
3538
Email
chlai@tmu.edu.tw
Facility Information:
Facility Name
Taipei Medical university Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chien-Hung Lai, MD PhD
12. IPD Sharing Statement
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Effectiveness of Robot-assisted Rehabilitation in Persons With Stroke
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