RehabilitationNCT06366477
Effects of Vibration Stimulation Combined With Task-oriented Training on Hand Motor Function in Chronic Stroke
A study testing Vibration stimulation combined with task-oriented training in people with Rehabilitation and Stroke, run by National Cheng-Kung University Hospital.
Trial summary
There is a lack of effective therapies for hand and finger function recovery in people with chronic stroke. This study assessed the effects of combining vibration stimulation with task-oriented training on functional recovery, and treatment persistence. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Rehabilitation, Stroke, Hand Grasp
- What is being tested?
- Vibration stimulation combined with task-oriented training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 15 Nov 2019
- 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
- Hemiparesis after stroke
- At least 6 months post-stroke
- Aged between 20 and 80 years
- Upper extremity Brunnstrom stage IV or V
- In stable medical condition
- No cognitive deficits (able to understand and follow the instructions)
Who cannot join
- Sensory impairment which may limit the participation in vibration stimulation treatment
- Other neurological or musculoskeletal impairments
- More than 2 by the Modified Ashworth Scale (0-5)
- Skin problems that prohibit participants from wearing the vibratory gloves
- Aphasia
- Apraxia
- Received other treatments which may influence motor or sensory abilities
- Participating in other studies in the past 6 months
About this study
Official title: Effects of Vibration Stimulation Combined With Task-oriented Training on Hand Motor Function in Chronic Stroke: a Case Series Study
There is a lack of effective therapies for hand and finger function recovery in people with chronic stroke. This study assessed the effects of combining vibration stimulation with task-oriented training on functional recovery, and treatment persistence. Participants with chronic stroke underwent 24 sessions of vibration stimulation combined with task-oriented training over 12 weeks, in addition to regular therapy. Functional recovery was assessed using the Fugl-Meyer assessment for motor function (FMA-wrist and hand), the Box and Blocks Test (BBT) for hand dexterity, and the Motor Activity Log (MAL) for daily functional activities. Minimal detectable change (MDC) and minimal important difference (MID) criteria were applied to interpret changes in assessment scores.
- Conditions
- Rehabilitation, Stroke, Hand Grasp
- Being tested
- Vibration stimulation combined with task-oriented training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibration stimulation combined with task-oriented trainingDevice
Participants with chronic stroke underwent 24 sessions of vibration stimulation combined with task-oriented training over 12 weeks, in addition to regular therapy.
| Study group | Role | What they receive |
|---|---|---|
| Vibration stimulation combined with task-oriented training | Experimental | Not described Receives: Device: Vibration stimulation combined with task-oriented training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer assessment - wrist and hand
Fugl-Meyer assessment - wrist and hand is used to assess wrist and hand motor impairments in people with post stroke hemiplegia. Scoring is conducted through the direct assessment of the individual's performance, whereby the 12 items on the scale are scored according to their level of completion using a 3-point ordinal scale: 0 indicating inability to perform, 1 indicating partial performance, and 2 indicating full performance. The minimum score is 0. The total score is 24. The higher the score, the better the hand and wrist motor function.
Measured: At baseline, 1 month after the start of the treatment, 2 months after the start of the treatment, 3 months after the start of the treatment, 1 month after the treatment ends and 3 months after the treatment ends.
Box and Blocks Test
Box and Blocks Test is a test of manual dexterity to assess hand function. The minimum score is 0. The total score is based on the number of blocks transferred from one box to the other in 60 seconds. Higher score is indicative of better hand dexterity.
Measured: At baseline, 1 month after the start of the treatment, 2 months after the start of the treatment, 3 months after the start of the treatment, 1 month after the treatment ends and 3 months after the treatment ends.
Motor Activity Log
The Motor Activity Log is a structured interview intended to measure an individual's real life functional affected upper limb performance. The Motor Activity Log consists of two subtests: one pertaining to the amount of use (AOU) and the other pertaining to the quality of movement (QOM) of the affected upper limb. The Motor Activity Log employs an 11-point Likert scale, ranging from 0 to 5 with half-point increments, to evaluate the AOU and QOM subtests. The scores for AOU vary from 0, indicating never use the affected limb for this activity, to 5, indicating always use. Similarly, the scores for QOM range from 0, representing an inability to use the affected limb during the activity, to 5, indicating an ability to use the affected limb just as proficiently as before the stroke. Higher scores represent better performance.
Measured: At baseline, 1 month after the start of the treatment, 2 months after the start of the treatment, 3 months after the start of the treatment, 1 month after the treatment ends and 3 months after the treatment ends.
Quantitative Electroencephalography Analysis: Delta Brain Symmetry Index
The Delta Brain Symmetry Index is a quantitative electroencephalography analysis used to assess hemispheric power lateralization and reflect improvements in hand motor functions. Delta Brain Symmetry Index ranges from 0 to 1, with higher indices indicating greater asymmetry and lower indices indicating more symmetry. Decreased Delta Brain Symmetry indicates a decrease in lateralization, potentially associated with brain reorganization that supports motor recovery.
Measured: At baseline, 3 months after the start of the treatment and 3 months after the treatment ends.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start1 Jan 2017
- Primary completion15 Jun 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 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
- NCT06366477
- Sponsor's protocol ID
- B-ER-103-417
- Status last verified
- Mar 2024
- First submitted
- 29 Mar 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Quantitative Electroencephalography (QEEG): changes in hemispheric power lateralization. Functional recovery was assessed using the Fugl-Meyer assessment for motor function (FMA-wrist and hand), the Box and Blocks Test (BBT) for hand dexterity, and the Motor Activity Log (MAL) for daily functional activities.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vibration Stimulation Combined With Task-oriented Training on Hand Motor Function in Chronic Stroke: a Case Series Study
- ClinicalTrials.gov ID
- NCT06366477
- Acronym / sponsor ID
- B-ER-103-417
- Conditions
- Rehabilitation, Stroke, Hand Grasp
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 16 Apr 2024 (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.
There is a lack of effective therapies for hand and finger function recovery in people with chronic stroke. This study assessed the effects of combining vibration stimulation with task-oriented training on functional recovery, and treatment persistence. Participants with chronic stroke underwent 24 sessions of vibration stimulation combined with task-oriented training over 12 weeks, in addition to regular therapy. Functional recovery was assessed using the Fugl-Meyer assessment for motor function (FMA-wrist and hand), the Box and Blocks Test (BBT) for hand dexterity, and the Motor Activity Log (MAL) for daily functional activities. Minimal detectable change (MDC) and minimal important difference (MID) criteria were applied to interpret changes in assessment scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vibration stimulation combined with task-oriented training | Experimental | Device: Vibration stimulation combined with task-oriented 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)
- Hemiparesis after stroke
- At least 6 months post-stroke
- Aged between 20 and 80 years
- Upper extremity Brunnstrom stage IV or V
- In stable medical condition
Key exclusion criteria (8 listed)
- Sensory impairment which may limit the participation in vibration stimulation treatment
- Other neurological or musculoskeletal impairments
- More than 2 by the Modified Ashworth Scale (0-5)
- Skin problems that prohibit participants from wearing the vibratory gloves
- Aphasia
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 |
|---|---|---|
| Vibration stimulation combined with task-oriented trainingParticipants with chronic stroke underwent 24 sessions of vibration stimulation combined with task-oriented training over 12 weeks, in addition to regular therapy. | Device | Vibration stimulation combined with task-oriented training |
Primary outcome
Fugl-Meyer assessment - wrist and hand
Time frame: At baseline, 1 month after the start of the treatment, 2 months after the start of the treatment, 3 months after the start of the treatment, 1 month after the treatment ends and 3 months after the treatment ends.
Fugl-Meyer assessment - wrist and hand is used to assess wrist and hand motor impairments in people with post stroke hemiplegia. Scoring is conducted through the direct assessment of the individual's performance, whereby the 12 items on the scale are scored according to their level of completion using a 3-point ordinal scale: 0 indicating inability to perform, 1 indicating partial performance, and 2 indicating full performance. The minimum score is 0. The total score is 24. The higher the score, the better the hand and wrist motor function.
Box and Blocks Test
Time frame: At baseline, 1 month after the start of the treatment, 2 months after the start of the treatment, 3 months after the start of the treatment, 1 month after the treatment ends and 3 months after the treatment ends.
Box and Blocks Test is a test of manual dexterity to assess hand function. The minimum score is 0. The total score is based on the number of blocks transferred from one box to the other in 60 seconds. Higher score is indicative of better hand dexterity.
Motor Activity Log
Time frame: At baseline, 1 month after the start of the treatment, 2 months after the start of the treatment, 3 months after the start of the treatment, 1 month after the treatment ends and 3 months after the treatment ends.
The Motor Activity Log is a structured interview intended to measure an individual's real life functional affected upper limb performance. The Motor Activity Log consists of two subtests: one pertaining to the amount of use (AOU) and the other pertaining to the quality of movement (QOM) of the affected upper limb. The Motor Activity Log employs an 11-point Likert scale, ranging from 0 to 5 with half-point increments, to evaluate the AOU and QOM subtests. The scores for AOU vary from 0, indicating never use the affected limb for this activity, to 5, indicating always use. Similarly, the scores for QOM range from 0, representing an inability to use the affected limb during the activity, to 5, indicating an ability to use the affected limb just as proficiently as before the stroke. Higher scores represent better performance.
Quantitative Electroencephalography Analysis: Delta Brain Symmetry Index
Time frame: At baseline, 3 months after the start of the treatment and 3 months after the treatment ends.
The Delta Brain Symmetry Index is a quantitative electroencephalography analysis used to assess hemispheric power lateralization and reflect improvements in hand motor functions. Delta Brain Symmetry Index ranges from 0 to 1, with higher indices indicating greater asymmetry and lower indices indicating more symmetry. Decreased Delta Brain Symmetry indicates a decrease in lateralization, potentially associated with brain reorganization that supports motor recovery.
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 16 Apr 2024.
- Individual participant dataSharing planned: No. Quantitative Electroencephalography (QEEG): changes in hemispheric power lateralization. Functional recovery was assessed using the Fugl-Meyer assessment for motor function (FMA-wrist and hand), the Box and Blocks Test (BBT) for hand dexterity, and the Motor Activity Log (MAL) for daily functional activities.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Vibration stimulation combined with task-oriented training in people with Rehabilitation and Stroke, run by National Cheng-Kung University Hospital.
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 8 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 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Fugl-Meyer assessment - wrist and hand (time frame: At baseline, 1 month after the start of the treatment, 2 months after the start of the treatment, 3 months after the start of the treatment, 1 month after the treatment ends and 3 months after the treatment ends.). The study lists 4 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 16 Apr 2024; AzTrials last refreshed its copy on 30 Oct 2026.