StrokeNCT04002076
Effectiveness of Robot-assisted Rehabilitation in Persons With Stroke
A study testing Robot-assisted hand combined with occupational therapy and Traditional occupational therapy in people with Stroke, run by Taipei Medical University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Robot-assisted hand combined with occupational therapy and Traditional occupational therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Aug 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mini-Mental State Examination score is above 23
- A first-ever stroke with unilateral hemiplegia or hemiparesis.
- Medical and psychological condition is stable.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical university Hospital
Taipei
Chien-Hung Lai, MD PhD
About this study
Official title: Effectiveness of Robot-assisted Rehabilitation on Upper Limb Function and Neuroplasticity in Persons With Stroke
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).
Read the 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.
- Conditions
- Stroke
- Being tested
- Robot-assisted hand combined with occupational therapy, Traditional occupational therapy
- Keywords
- stroke, Robot-assisted Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted hand combined with occupational therapyBehavioural
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.
Traditional occupational therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Robot-assisted hand combined with occupational therapy | Experimental | 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. Receives: Behavioral: Robot-assisted hand combined with occupational therapy |
| Traditional occupational therapy | Active comparator | 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. Receives: Behavioral: Traditional occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Measurement before and after intervention ( week 0 and at the end of week 6) in both groups
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.
Measured: [Time Frame: Measurement before and after intervention ( week 0 and at the end of week 6) in both groups]
Secondary outcomes (3)
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).
Measured: Measurement before and after intervention ( week 0 and at the end of week 6) in both groups
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
Measured: Measurement before and after intervention ( week 0 and at the end of week 6) in both groups
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).
Measured: Measurement before and after intervention ( week 0 and at the end of week 6) in both groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start7 Aug 2019
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lai chien hung, Taipei Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002076
- Sponsor's protocol ID
- N201904042
- Status last verified
- Jan 2023
- First submitted
- 27 Jun 2019
- Last updated
- 31 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Robot-assisted Rehabilitation on Upper Limb Function and Neuroplasticity in Persons With Stroke
- ClinicalTrials.gov ID
- NCT04002076
- Acronym / sponsor ID
- N201904042
- Conditions
- Stroke
- Keywords
- stroke, Robot-assisted Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Taipei Medical University HospitalUniversity, hospital or other
- Study start
- 7 Aug 2019 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 28 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted hand combined with occupational therapy | Experimental | Behavioral: Robot-assisted hand combined with occupational therapyTen 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. |
| Traditional occupational therapy | Active comparator | Behavioral: Traditional occupational therapyAnother 10 participants allocated to the group B will receive 60 minutes a day and 3 days a week traditional occupational therapy for six weeks. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mini-Mental State Examination score is above 23
- A first-ever stroke with unilateral hemiplegia or hemiparesis.
- Medical and psychological condition is stable.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot-assisted hand combined with occupational therapyRobot-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. | Behavioural | Robot-assisted hand combined with occupational therapy |
| Traditional occupational therapyOccupational 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. | Behavioural | Traditional occupational therapy |
Primary outcome
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.
3 secondary outcomes
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-assisted hand combined with occupational therapy and Traditional occupational therapy in people with Stroke, run by Taipei Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chien-Hung Lai, MD PhD (886-2-27372181 ext. 3538, chlai@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.