Stroke RehabilitationNCT03798340
Vibratory Perturbation-based Pinch Task Training for Stroke Patients
A study testing Vibratory perturbed task-specific movement training, Traditional task-oriented facilitation and Sensorimotor training in people with Stroke Rehabilitation, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
The investigator assumed that perturbed-event-induced vibrotactile cueing enable more precision arm movement adjustment, sensory function and dexterity improvement in the spastic arm. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke Rehabilitation
- What is being tested?
- Vibratory perturbed task-specific movement training, Traditional task-oriented facilitation and Sensorimotor training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Mar 2016to 31 Dec 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of unilateral cerebral infarction or hemorrhage
- Be able to perform a pinch task with the thumb and index finger
- With premorbid right-handedness
Who cannot join
- Subject has a uncontrolled hypertension
- Subject has major cognitive-perceptual deficits
- Subject has other brain disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Motor Task-Specific Therapy Synchronized With Vibrotactile Cueing on Sensorimotor Performance of Upper Extremity for the Chronic Stroke Patients
The investigator assumed that perturbed-event-induced vibrotactile cueing enable more precision arm movement adjustment, sensory function and dexterity improvement in the spastic arm. Thus the specific aim of the study was to develop a vibrotactile therapy system that can provide vibrotactile feedback through the pinch performance of the hand when countering mechanically induced perturbations and also analyzed training effects of the perturbation-based pinch task training system on the sensorimotor performance of the hands for stroke patients.
- Conditions
- Stroke Rehabilitation
- Being tested
- Vibratory perturbed task-specific movement training, Traditional task-oriented facilitation, Sensorimotor training
- Keywords
- stroke, perturbation-based training, task-specific motor training, recovery of function
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibratory perturbed task-specific movement trainingOther
The perturbation-based pinch task training was conducted with the affected hand placed on the pinch device. The horizontal vibratory perturbation was generated for a total of 20 minutes by two recoil-type actuators with a frequency of 30 Hz and an amplitude of 2 mm, and intermittent exposure (10 s per 30 s). Each training session was divided into eight cycles with a training interval of 2 min per 2.5 min.
Traditional task-oriented facilitationOther
Reach-to-grasp training and hand release training
Sensorimotor trainingOther
Targeted to goals that are relevant to the sensorimotor facilitation of the patient
| Study group | Role | What they receive |
|---|---|---|
| Vibratory perturbed task-specific movement training | Experimental | Intervention: 10 minutes of traditional sensorimotor facilitation followed by 20 minutes of vibratory perturbed task-specific movement training Receives: Other: Vibratory perturbed task-specific movement training; Other: Sensorimotor training |
| Traditional task-oriented facilitation | Active comparator | Intervention:10 minutes of traditional sensorimotor training followed by 20 minutes of reach-to-grasp and hand release training. Receives: Other: Traditional task-oriented facilitation; Other: Sensorimotor training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (6 weeks) and follow up (18 weeks)
Change in the result of Modified Ashworth scale (MAS)
Muscle tone is defined by the resistance of a muscle being stretched.The tester graded the resistance felt, with a single score. The higher values represent a worse outcome. 0 point for no increase in muscle tone; 1 point for slight increase in muscle tone, manifested by a catch or by minimal resistance at the end of the range of motion (ROM) when the affected part is moved in flexion or extension; 1 + for slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM; 2 point for more marked increase in muscle tone through most of the ROM, but affected parteasily moved, 3 point for considerable increase in muscle tone and passive movement difficult; 4 point for affected part rigid in flexion or extension.
Measured: baseline, endpoint (6 weeks) and follow up (18 weeks)
Change in the result of Box and blocks test
The score is the number of blocks carried from one box to the other in one minute. Higher values represent a better outcome.
Measured: baseline, endpoint (6 weeks) and follow up (18 weeks)
Change in the result of Semmes-Weinstein monofilament (SWM) test
The Semmes-Weinstein monofilamenttest examines the cutaneous pressure threshold, range from 1.65-6.65. Higher values represent a worse outcome.
Measured: baseline, endpoint (6 weeks) and follow up (18 weeks)
Change in the result of Motor Activity Log
MAL 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 (6 weeks) and follow up (18 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start24 Mar 2016
- Primary completion4 Oct 2016
- Study completion31 Dec 2016
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
- 20 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
- NCT03798340
- Sponsor's protocol ID
- A-ER-104-206
- Status last verified
- Jan 2019
- First submitted
- 7 Jan 2019
- Last updated
- 30 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
Publications
Hsu HY, Kuan TS, Tsai CL, Wu PT, Kuo YL, Su FC, Kuo LC. Effect of a Novel Perturbation-Based Pinch Task Training on Sensorimotor Performance of Upper Extremity for Patients With Chronic Stroke: A Pilot Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 May;102(5):811-818. doi: 10.1016/j.apmr.2020.11.004. Epub 2020 Dec 2.
PubMed 33278364
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Motor Task-Specific Therapy Synchronized With Vibrotactile Cueing on Sensorimotor Performance of Upper Extremity for the Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT03798340
- Acronym / sponsor ID
- A-ER-104-206
- Conditions
- Stroke Rehabilitation
- Keywords
- stroke, perturbation-based training, task-specific motor training, recovery of function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 24 Mar 2016 (actual)
- Primary completion
- 4 Oct 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 9 Jan 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.
The investigator assumed that perturbed-event-induced vibrotactile cueing enable more precision arm movement adjustment, sensory function and dexterity improvement in the spastic arm. Thus the specific aim of the study was to develop a vibrotactile therapy system that can provide vibrotactile feedback through the pinch performance of the hand when countering mechanically induced perturbations and also analyzed training effects of the perturbation-based pinch task training system on the sensorimotor performance of the hands for 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 |
|---|---|---|
| Vibratory perturbed task-specific movement training | Experimental | Other: Vibratory perturbed task-specific movement training, Other: Sensorimotor trainingIntervention: 10 minutes of traditional sensorimotor facilitation followed by 20 minutes of vibratory perturbed task-specific movement training |
| Traditional task-oriented facilitation | Active comparator | Other: Traditional task-oriented facilitation, Other: Sensorimotor trainingIntervention:10 minutes of traditional sensorimotor training followed by 20 minutes of reach-to-grasp and hand release training. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of unilateral cerebral infarction or hemorrhage
- Be able to perform a pinch task with the thumb and index finger
- With premorbid right-handedness
Key exclusion criteria (3 listed)
- Subject has a uncontrolled hypertension
- Subject has major cognitive-perceptual deficits
- Subject has other brain disease
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 |
|---|---|---|
| Vibratory perturbed task-specific movement trainingThe perturbation-based pinch task training was conducted with the affected hand placed on the pinch device. The horizontal vibratory perturbation was generated for a total of 20 minutes by two recoil-type actuators with a frequency of 30 Hz and an amplitude of 2 mm, and intermittent exposure (10 s per 30 s). Each training session was divided into eight cycles with a training interval of 2 min per 2.5 min. | Other | Vibratory perturbed task-specific movement training |
| Traditional task-oriented facilitationReach-to-grasp training and hand release training | Other | Traditional task-oriented facilitation |
| Sensorimotor trainingTargeted to goals that are relevant to the sensorimotor facilitation of the patient | Other | Traditional task-oriented facilitation, Vibratory perturbed task-specific movement training |
Primary outcome
Change in the result of Fugl-Meyer assessment for UE motor function
Time frame: baseline, endpoint (6 weeks) and follow up (18 weeks)
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.
Change in the result of Modified Ashworth scale (MAS)
Time frame: baseline, endpoint (6 weeks) and follow up (18 weeks)
Muscle tone is defined by the resistance of a muscle being stretched.The tester graded the resistance felt, with a single score. The higher values represent a worse outcome. 0 point for no increase in muscle tone; 1 point for slight increase in muscle tone, manifested by a catch or by minimal resistance at the end of the range of motion (ROM) when the affected part is moved in flexion or extension; 1 + for slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM; 2 point for more marked increase in muscle tone through most of the ROM, but affected parteasily moved, 3 point for considerable increase in muscle tone and passive movement difficult; 4 point for affected part rigid in flexion or extension.
Change in the result of Box and blocks test
Time frame: baseline, endpoint (6 weeks) and follow up (18 weeks)
The score is the number of blocks carried from one box to the other in one minute. Higher values represent a better outcome.
Change in the result of Semmes-Weinstein monofilament (SWM) test
Time frame: baseline, endpoint (6 weeks) and follow up (18 weeks)
The Semmes-Weinstein monofilamenttest examines the cutaneous pressure threshold, range from 1.65-6.65. Higher values represent a worse outcome.
Change in the result of Motor Activity Log
Time frame: baseline, endpoint (6 weeks) and follow up (18 weeks)
MAL 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.
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 30 Jan 2019.
- Derived from this study: PubMed 33278364Hsu HY, Kuan TS, Tsai CL, Wu PT, Kuo YL, Su FC, Kuo LC. Effect of a Novel Perturbation-Based Pinch Task Training on Sensorimotor Performance of Upper Extremity for Patients With Chronic Stroke: A Pilot Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 May;102(5):811-818. doi: 10.1016/j.apmr.2020.11.004. Epub 2020 Dec 2.
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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 Vibratory perturbed task-specific movement training, Traditional task-oriented facilitation and Sensorimotor training 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 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: finished, as of the sponsor's last update on 30 Jan 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 Fugl-Meyer assessment for UE motor function (time frame: baseline, endpoint (6 weeks) and follow up (18 weeks)). The study lists 5 primary outcomes in all. 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 NCT03798340, 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 30 Jan 2019.