Clinical trial NCT06366477: Effects of Vibration Stimulation Combined With Task-oriented Training on Hand Motor Function in Chronic Stroke
Official title: Effects of Vibration Stimulation Combined With Task-oriented Training on Hand Motor Function in Chronic Stroke: a Case Series Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rehabilitation
Stroke
Hand Grasp
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 3
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Fugl-Meyer assessment - wrist and hand
timeFrame: 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.
measure: Box and Blocks Test
timeFrame: 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.
measure: Motor Activity Log
timeFrame: 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.
measure: Quantitative Electroencephalography Analysis: Delta Brain Symmetry Index
timeFrame: At baseline, 3 months after the start of the treatment and 3 months after the treatment ends.
Secondary outcomes:
Other outcomes:
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