Skip to main content
OpenTrials
Completed

NCT Number: NCT06366477

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Vibration stimulation combined with task-oriented training

Device

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study title

Effects of Vibration Stimulation Combined With Task-oriented Training on Hand Motor Function in Chronic Stroke: a Case Series Study

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 16, 2024
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.