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CompletedNCT06366477Updated Apr 16, 2024

Effects of Vibration Stimulation Combined With Task-oriented Training on Hand Motor Function in Chronic Stroke

An interventional study of Vibration stimulation combined with task-oriented training in Rehabilitation, Stroke and Hand Grasp, sponsored by National Cheng-Kung University Hospital. Completed. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-16.

Sponsored by National Cheng-Kung University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 years 2 months after the study started (first participant enrolled Jan 2017, registered Mar 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
20 Years to 80 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • Rehabilitation
  • Stroke
  • Hand Grasp

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03

In context

Stroke

7,443 studies on the registry are indexed under Stroke; 2,012 are open to participants now.

This study's enrollment of 3 is below the median of 50 across 5,482 interventional studies indexed under Stroke.

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Lead sponsor

National Cheng-Kung University Hospital is the lead sponsor of 276 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    Vibration stimulation combined with task-oriented training

    Device: Vibration stimulation combined with task-oriented training

Interventions

  • DeviceVibration stimulation combined with task-oriented training

    Participants with chronic stroke underwent 24 sessions of vibration stimulation combined with task-oriented training over 12 weeks, in addition to regular therapy.

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What researchers measure

Primary outcomes

  1. 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.

    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.

  2. 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.

    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.

  3. 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.

    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.

  4. 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.

    Time frame: At baseline, 3 months after the start of the treatment and 3 months after the treatment ends.

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06366477
Responsible party
Sponsor
First posted
Apr 16, 2024
Start date
Jan 1, 2017
Primary completion
Jun 15, 2019
Completion
Nov 15, 2019
Last update
Apr 16, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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