NCT05969249

Vibration Approach Functions in Upper Extremities for People After Stroke

Investigating the Effects of Vibration Approach on Improving Motor, Perception and Functions in Upper Extremities for People After Stroke

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Taipei Medical University Shuang Ho Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	Upper limb in vibration training	The stroke subjects were all involved in the training,wear upper and lower extremity vibrators,the posture for intervention is hemiplegic upper limbs with shoulder joints slightly bent and abducted at 45 degrees, with elbows bent at 90 degrees and wrists centered. The elbow angle of this posture is set by the elbow joint rotation axis of the upper limb vibrator. The set angle is the movable angle range of 80-110 degrees of elbow bending. The vibration rehabilitation password accepted by all subjects is "Try to keep the elbow joint bent at 90 degrees during the vibration process, Resist the force of the vibration and try not to move".

Timeline

• Start date: 2023-08-07
• Primary completion: 2024-08-01
• Completion: 2024-08-31
• First posted: 2023-08-01
• Last updated: 2023-08-01