Stroke RehabilitationNCT03847103
Robotic-assisted Therapy With Bilateral Practice Improves Task and Motor Performance of the Upper Extremity for Chronic Stroke Patients
A study testing Robotic-assisted Therapy with Bilateral Practice, Unilateral Task-specific Training and Sensorimotor Stimulation Program in people with Stroke Rehabilitation, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
Task-specific repetitive training, an usual care in occupational therapy practice, and robotic-aided rehabilitation with bilateral practice to improve limb's movement control has been popularised; however the difference in treatment effects between this two therapeutic strategies has been rarely described. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke Rehabilitation
- What is being tested?
- Robotic-assisted Therapy with Bilateral Practice, Unilateral Task-specific Training and Sensorimotor Stimulation Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Apr 2014to 2 Mar 2017
- 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
- chronic stroke patients with unilateral cerebral infarction or hemorrhage and whose disease duration was more than six months following stroke
- no evidence of any other cerebral pathology in study screening CT scan
- a score for the Fugl-Meyer upper extremity motor assessment ranging from 23-53 corresponding to poor to notable arm-hand capacity
- pre stroke ability to speak the Chinese
- without any other possible somatic sensory impairment, no major cognitive-perceptual deficit based on the results of selective neuropsychological tests, such as the mini-mental state examination (MMSE) and Lowenstein occupational therapy cognitive assessment (LOTCA)
- premorbid right-handedness
Who cannot join
- less than six months following stroke
- CT shows multiple cerebral infarction or hemorrhage
- whose comprehension skills were insufficient to understand instructions
- individuals whose score of MMSE was lower than 24 or sub-item scores of visual perception, spatial perception, praxis, and visuomotor organization in LOTCA was lower than 8, 6, 6, and 14, respectively
- premorbid left-handedness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Robotic-aided Therapy Combined With Bilateral Arm Training on Motor Performance and Electrophysiological Parameters of Upper Extremity for the Stroke Patients
Task-specific repetitive training, an usual care in occupational therapy practice, and robotic-aided rehabilitation with bilateral practice to improve limb's movement control has been popularised; however the difference in treatment effects between this two therapeutic strategies has been rarely described. The aim of the study was to compare the efficacy of robotic-assisted therapy with bilateral practice (RTBP) and usual care on task and motor performance for chronic stroke patients.
- Conditions
- Stroke Rehabilitation
- Being tested
- Robotic-assisted Therapy with Bilateral Practice, Unilateral Task-specific Training, Sensorimotor Stimulation Program
- Keywords
- Stroke, Robotic-Assisted Therapy, Bilateral Practice, Task-specific Training, Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-assisted Therapy with Bilateral PracticeOther
40-minute robotic-assisted therapy with bilateral practice program for wrist and forearm repetitive movement training was performed during each session.
Unilateral Task-specific TrainingOther
40 -minute unilateral task-specific training using various tasks: picks up beans with spoon, pouring water from one glass to another glass, opening and closing a drawer, drinking from a mug, and wiping the table were chosen for facilitating multitude of upper extremity functions. Three tasks per session were chosen for various specific components of hand-arm function training.
Sensorimotor Stimulation ProgramOther
10-minute sensorimotor stimulation program with repetitive range of motion exercises of upper extremity, proprioceptive neuromuscular facilitation and Rood approach
| Study group | Role | What they receive |
|---|---|---|
| Robotic-aided rehabilitation with bilateral practice | Experimental | In addition to a 10-minutes sensorimotor stimulation programs, the experimental group received 40-minutes Robotic-assisted Therapy with Bilateral Practice programs. Receives: Other: Robotic-assisted Therapy with Bilateral Practice; Other: Sensorimotor Stimulation Program |
| Unilateral task-specific training | Active comparator | In addition to a 10-minutes sensorimotor stimulation programs, the control subjects received 40-minute unilateral task-specific training. Receives: Other: Unilateral Task-specific Training; Other: Sensorimotor Stimulation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the result of Motor Activity Log
Motor activity log is a structured interview with testing sensitivity used to examine how much (amount of use, AOU) and how well (quality of movement, QOM) the subject uses their more-affected arm. For the 30 items MAL, each item is scored on a 0-5-ordinal scale.
Measured: Baseline, endpoint (4 weeks) and follow-up (16 weeks) assessments
Secondary outcomes (2)
Change in the result of Fugl-Meyer assessment for UE motor function
Each item is rated on a three-point ordinal scale (2 points for the detail being performed completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity.completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity.
Measured: Baseline, endpoint (4 weeks) and follow-up (16 weeks) assessments
Change in root mean square (RMS) value and the median frequency of the power spectrum of each detected motor unit action potential during maximum voluntary contraction
Power and frequency function of Surface Electromyogram signals are reliable parameter to evaluate motor behavior of stroke survivors. The location sEMG electrodes were placed on the muscle belly of the anterior deltoid, flexor carpi radialis and extensor carpi radialis of the affected forearm.
Measured: Baseline, endpoint (4 weeks) and follow-up (16 weeks) assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start15 Apr 2014
- Primary completion2 Mar 2017
- Study completion2 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke RehabilitationStudies 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03847103
- Sponsor's protocol ID
- B-ER-102-247
- Status last verified
- Feb 2019
- First submitted
- 12 Feb 2019
- Last updated
- 1 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hsu HY, Chiu HY, Kuan TS, Tsai CL, Su FC, Kuo LC. Robotic-assisted therapy with bilateral practice improves task and motor performance in the upper extremities of chronic stroke patients: A randomised controlled trial. Aust Occup Ther J. 2019 Oct;66(5):637-647. doi: 10.1111/1440-1630.12602. Epub 2019 Jul 17.
PubMed 31317553
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Robotic-aided Therapy Combined With Bilateral Arm Training on Motor Performance and Electrophysiological Parameters of Upper Extremity for the Stroke Patients
- ClinicalTrials.gov ID
- NCT03847103
- Acronym / sponsor ID
- B-ER-102-247
- Conditions
- Stroke Rehabilitation
- Keywords
- Stroke, Robotic-Assisted Therapy, Bilateral Practice, Task-specific Training, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 15 Apr 2014 (actual)
- Primary completion
- 2 Mar 2017 (actual)
- Study completion
- 2 Mar 2017 (actual)
- First posted
- 20 Feb 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.
Task-specific repetitive training, an usual care in occupational therapy practice, and robotic-aided rehabilitation with bilateral practice to improve limb's movement control has been popularised; however the difference in treatment effects between this two therapeutic strategies has been rarely described. The aim of the study was to compare the efficacy of robotic-assisted therapy with bilateral practice (RTBP) and usual care on task and motor performance for chronic stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic-aided rehabilitation with bilateral practice | Experimental | Other: Robotic-assisted Therapy with Bilateral Practice, Other: Sensorimotor Stimulation ProgramIn addition to a 10-minutes sensorimotor stimulation programs, the experimental group received 40-minutes Robotic-assisted Therapy with Bilateral Practice programs. |
| Unilateral task-specific training | Active comparator | Other: Unilateral Task-specific Training, Other: Sensorimotor Stimulation ProgramIn addition to a 10-minutes sensorimotor stimulation programs, the control subjects received 40-minute unilateral task-specific training. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- chronic stroke patients with unilateral cerebral infarction or hemorrhage and whose disease duration was more than six months following stroke
- no evidence of any other cerebral pathology in study screening CT scan
- a score for the Fugl-Meyer upper extremity motor assessment ranging from 23-53 corresponding to poor to notable arm-hand capacity
- pre stroke ability to speak the Chinese
- without any other possible somatic sensory impairment, no major cognitive-perceptual deficit based on the results of selective neuropsychological tests, such as the mini-mental state examination (MMSE) and Lowenstein occupational therapy cognitive assessment (LOTCA)
Key exclusion criteria (5 listed)
- less than six months following stroke
- CT shows multiple cerebral infarction or hemorrhage
- whose comprehension skills were insufficient to understand instructions
- individuals whose score of MMSE was lower than 24 or sub-item scores of visual perception, spatial perception, praxis, and visuomotor organization in LOTCA was lower than 8, 6, 6, and 14, respectively
- premorbid left-handedness
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 |
|---|---|---|
| Robotic-assisted Therapy with Bilateral Practice40-minute robotic-assisted therapy with bilateral practice program for wrist and forearm repetitive movement training was performed during each session. | Other | Robotic-aided rehabilitation with bilateral practice |
| Unilateral Task-specific Training40 -minute unilateral task-specific training using various tasks: picks up beans with spoon, pouring water from one glass to another glass, opening and closing a drawer, drinking from a mug, and wiping the table were chosen for facilitating multitude of upper extremity functions. Three tasks per session were chosen for various specific components of hand-arm function training. | Other | Unilateral task-specific training |
| Sensorimotor Stimulation Program10-minute sensorimotor stimulation program with repetitive range of motion exercises of upper extremity, proprioceptive neuromuscular facilitation and Rood approach | Other | Robotic-aided rehabilitation with bilateral practice, Unilateral task-specific training |
Primary outcome
Change in the result of Motor Activity Log
Time frame: Baseline, endpoint (4 weeks) and follow-up (16 weeks) assessments
Motor activity log is a structured interview with testing sensitivity used to examine how much (amount of use, AOU) and how well (quality of movement, QOM) the subject uses their more-affected arm. For the 30 items MAL, each item is scored on a 0-5-ordinal scale.
2 secondary outcomes
Change in the result of Fugl-Meyer assessment for UE motor function
Time frame: Baseline, endpoint (4 weeks) and follow-up (16 weeks) assessments
Change in root mean square (RMS) value and the median frequency of the power spectrum of each detected motor unit action potential during maximum voluntary contraction
Time frame: Baseline, endpoint (4 weeks) and follow-up (16 weeks) assessments
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
- Derived from this study: PubMed 31317553Hsu HY, Chiu HY, Kuan TS, Tsai CL, Su FC, Kuo LC. Robotic-assisted therapy with bilateral practice improves task and motor performance in the upper extremities of chronic stroke patients: A randomised controlled trial. Aust Occup Ther J. 2019 Oct;66(5):637-647. doi: 10.1111/1440-1630.12602. Epub 2019 Jul 17.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic-assisted Therapy with Bilateral Practice, Unilateral Task-specific Training and Sensorimotor Stimulation Program in people with Stroke Rehabilitation, run by National Cheng-Kung 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 1 Mar 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the result of Motor Activity Log (time frame: Baseline, endpoint (4 weeks) and follow-up (16 weeks) assessments). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03847103, which also lists 1 linked publication.
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 1 Mar 2019.