Clinical trial NCT05969249: Vibration Approach Functions in Upper Extremities for People After Stroke
Official title: Investigating the Effects of Vibration Approach on Improving Motor, Perception and Functions in Upper Extremities for People After Stroke
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 124
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will develop a vibration rehabilitation system for the upper extremities and provide strong evidence-based information regarding the mechanism and rehabilitation of stroke patients through the application of vibration by comparing the benefits of its clinical outcome with those of traditional rehabilitation methods. Based on these findings, we could create precision vibration exercise programs to improve the health of stroke patients.

Detailed description: Background: Stroke not only results in brain injury, muscle weakness, impairment of perception, and motor and functional impairments, but also leads to limited activities and long-term disabilities. Vibration exercise can improve muscle strength and motor performances in older adults. However, consistent and evidence-based benefits of vibration on neurorehabilitation for people after stroke are still limited. Therefore, vibration exercises cannot be applied effectively to improve motor, perception, and functional impairments in people after stroke. Therefore, the purpose of this study is to investigate the effects of vibration approach on improving motor, perception and functions in extremities for people after stroke. Methods: 124 stroke patients will be invited to participate in this study, and randomized assign to vibration training (n=62) and traditional rehabilitation(n=62) groups. The participants in vibration training and traditional rehabilitation groups will conduct the vibration program and traditional rehabilitation program for 60 mins in each section, 2 sections per week for eight weeks. The outcome measurements for motor, perception and functions in extremities, including the Fugl-Meyer Assessment (FMA), Motor Assessment Score (MAS), Minnesota Manual Dexterity Test (MMDT), active and passive joint perception tests, coordination control tasks in bilateral hand grip strength and bilateral ankle movement, Barth Index (BI), Wlof Motor Function Test (WMFT), Berg Balance Test (BBS), Time Up and Go (TUG) and gait analysis. Preliminary findings: Our team indicated that vibrations between 15 Hz - 45 Hz from a vibrator can significantly induce upper-limb muscle activity. Horizontal and vertical vibrations result in stronger upper-limb flexor and extensor muscle activations, respectively. Our results also showed that after the 8-week vibration intervention (frequency: 30 Hz, amplitude: 5 mm), participants in the vibration group had better muscle strength than those who received conventional physical exercise. Data analysis: In this study, a blind statistical expert will be invited to present the basic data of the subjects with descriptive statistics. If the data attribute is continuous variation, the Mann-Whitney U test (Mann-Whitney U test) will be used for comparison between the two groups; if the data attribute is categorical variation, the Chi-square test will be used for comparison between the two groups. As for the differences in movement, body sensation and function between the two groups before and after the intervention, two-way mixed analyzes of variance (ANOVA) will be used for statistical analysis. The statistical software used in the study is SPSS version 17.0. Statistically significant differences were set at p\<0.05.

Eligibility criteria: Inclusion Criteria:

1. The doctor diagnosed cerebrovascular disease caused by cerebrovascular embolism or hemorrhage
2. The patient suffers from stroke and has no other serious complications that significantly affect upper limb function
3. The stroke is stable
4. The degree of recovery from stroke has reached the third stage of the Brownstrong action stage or more
5. The subject's cognitive function is normal;
6. The muscle tension of the hemiplegic limb must be less than 3 on the modified Ashewurth scale
7. Vibration or rehabilitation intervention can be performed for 1 hour under the balance of sitting posture
8. Understand the experiment and agree

Exclusion Criteria:

1. This stroke is a recurrence
2. The muscle tension of the hemiplegic limbs is too high and they are completely unable to exercise alone
3. The patient has unilateral hemianopia or significant unilateral neglect in vision, which seriously affects the execution of physical movements
4. Patients with vestibular, cerebellum and other diseases that seriously affect the execution of movements
5. Patients with orthopedic or trauma and other factors that cause discomfort such as pain during evaluation or intervention
6. Patients who are unable to communicate effectively due to cognitive abnormalities caused by stroke
7. The patient has other related factors such as neurological and psychiatric diseases, which are affected by physical activity during the experiment

Primary outcomes:
measure: Upper Extremity motor control of Fugl-Meyer Assessment (FMA-UE)
timeFrame: Change from Baseline at eight weeks
measure: Motor Assessment Score
timeFrame: Change from Baseline at eight weeks
measure: Minnesota Manual Dexterity Test
timeFrame: Change from Baseline at eight weeks
measure: active and passive joint perception tests and coordination control tasks in bilateral hand grip strength
timeFrame: Change from Baseline at eight weeks
measure: the Wolf Motor Function Test
timeFrame: Change from Baseline at eight weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: 250 Wu-Hsing Street, Taipei City, Taiwan 110, R.O.C.
name: Chueh-Ho Lin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: