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Vibration Approach Functions in Upper Extremities for People After Stroke

Primary Purpose

Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Upper limb in vibration training
Sponsored by
Taipei Medical University Shuang Ho Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The doctor diagnosed cerebrovascular disease caused by cerebrovascular embolism or hemorrhage The patient suffers from stroke and has no other serious complications that significantly affect upper limb function The stroke is stable The degree of recovery from stroke has reached the third stage of the Brownstrong action stage or more The subject's cognitive function is normal; The muscle tension of the hemiplegic limb must be less than 3 on the modified Ashewurth scale Vibration or rehabilitation intervention can be performed for 1 hour under the balance of sitting posture Understand the experiment and agree Exclusion Criteria: This stroke is a recurrence The muscle tension of the hemiplegic limbs is too high and they are completely unable to exercise alone The patient has unilateral hemianopia or significant unilateral neglect in vision, which seriously affects the execution of physical movements Patients with vestibular, cerebellum and other diseases that seriously affect the execution of movements Patients with orthopedic or trauma and other factors that cause discomfort such as pain during evaluation or intervention Patients who are unable to communicate effectively due to cognitive abnormalities caused by stroke The patient has other related factors such as neurological and psychiatric diseases, which are affected by physical activity during the experiment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental

    Active Comparator:

    Arm Description

    Each patient will go on a treatment with 24 sections, and each section is 60 minutes. The experimental group received 30 minutes of effective vibration intervention with a vibration frequency of 30 Hz and an amplitude of 5 mm on the affected upper limb. The vibration duration was 1 minute, and there was also a 1-minute rest interval. After completion, 30 minutes of traditional clinical rehabilitation training was also performed.

    Each patient will go on a treatment with 24 sections, and each section is 60 minutes. During the intervention, it is necessary to wear an upper limb vibration device on the affected limb, and perform a sham vibration intervention (sham vibration) with a vibration frequency of 1 Hz (excluding the effective vibration frequency range of 4-50 Hz proposed in previous studies) and an amplitude of 5 mm for 30 minutes. The duration of the vibration is 1 minute, and there is a rest interval of 1 minute. After completion, 30 minutes of traditional clinical rehabilitation training will be performed.

    Outcomes

    Primary Outcome Measures

    Upper Extremity motor control of Fugl-Meyer Assessment (FMA-UE)
    Assessment the upper limb movement, sensation and coordination ability of stroke patients,
    Motor Assessment Score
    Assessment level of impairment and upper arm function, hand movements and advanced hand activities in patients with stroke. Patients perform each task 3 times, only the best performance is recorded. Items are assessed using a 7-point scale (0 to 6) and score of 6 indicates optimal motor behavior.
    Minnesota Manual Dexterity Test
    This test intends to assess bimanual dexterity and coordination. The MMDT consists of a thin board with 60 holes. The blocks have a diameter of 3.7 cms and are red and black. The blocks and holes are approximately the same size. It has 2 subsets the placing test and the turning test. A log is maintained of the time taken for these steps.
    active and passive joint perception tests and coordination control tasks in bilateral hand grip strength
    The task operation process includes the three parts of grip force formation, sustained grip and grip force release, which are performed alternately between the two hands at the same time.The grip strength between the left and right hands is continued alternately for 3 rounds. The data analysis is to take the best performance among the 3 rounds for analysis.
    the Wolf Motor Function Test
    Through timed and practical exercises, the Wolf Motor Function Test measures upper extremity motor abilities.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 24, 2023
    Last Updated
    July 24, 2023
    Sponsor
    Taipei Medical University Shuang Ho Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05969249
    Brief Title
    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

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 7, 2023 (Anticipated)
    Primary Completion Date
    August 1, 2024 (Anticipated)
    Study Completion Date
    August 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Taipei Medical University Shuang Ho Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    124 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental
    Arm Type
    Experimental
    Arm Description
    Each patient will go on a treatment with 24 sections, and each section is 60 minutes. The experimental group received 30 minutes of effective vibration intervention with a vibration frequency of 30 Hz and an amplitude of 5 mm on the affected upper limb. The vibration duration was 1 minute, and there was also a 1-minute rest interval. After completion, 30 minutes of traditional clinical rehabilitation training was also performed.
    Arm Title
    Active Comparator:
    Arm Type
    Active Comparator
    Arm Description
    Each patient will go on a treatment with 24 sections, and each section is 60 minutes. During the intervention, it is necessary to wear an upper limb vibration device on the affected limb, and perform a sham vibration intervention (sham vibration) with a vibration frequency of 1 Hz (excluding the effective vibration frequency range of 4-50 Hz proposed in previous studies) and an amplitude of 5 mm for 30 minutes. The duration of the vibration is 1 minute, and there is a rest interval of 1 minute. After completion, 30 minutes of traditional clinical rehabilitation training will be performed.
    Intervention Type
    Device
    Intervention Name(s)
    Upper limb in vibration training
    Intervention Description
    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".
    Primary Outcome Measure Information:
    Title
    Upper Extremity motor control of Fugl-Meyer Assessment (FMA-UE)
    Description
    Assessment the upper limb movement, sensation and coordination ability of stroke patients,
    Time Frame
    Change from Baseline at eight weeks
    Title
    Motor Assessment Score
    Description
    Assessment level of impairment and upper arm function, hand movements and advanced hand activities in patients with stroke. Patients perform each task 3 times, only the best performance is recorded. Items are assessed using a 7-point scale (0 to 6) and score of 6 indicates optimal motor behavior.
    Time Frame
    Change from Baseline at eight weeks
    Title
    Minnesota Manual Dexterity Test
    Description
    This test intends to assess bimanual dexterity and coordination. The MMDT consists of a thin board with 60 holes. The blocks have a diameter of 3.7 cms and are red and black. The blocks and holes are approximately the same size. It has 2 subsets the placing test and the turning test. A log is maintained of the time taken for these steps.
    Time Frame
    Change from Baseline at eight weeks
    Title
    active and passive joint perception tests and coordination control tasks in bilateral hand grip strength
    Description
    The task operation process includes the three parts of grip force formation, sustained grip and grip force release, which are performed alternately between the two hands at the same time.The grip strength between the left and right hands is continued alternately for 3 rounds. The data analysis is to take the best performance among the 3 rounds for analysis.
    Time Frame
    Change from Baseline at eight weeks
    Title
    the Wolf Motor Function Test
    Description
    Through timed and practical exercises, the Wolf Motor Function Test measures upper extremity motor abilities.
    Time Frame
    Change from Baseline at eight weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The doctor diagnosed cerebrovascular disease caused by cerebrovascular embolism or hemorrhage The patient suffers from stroke and has no other serious complications that significantly affect upper limb function The stroke is stable The degree of recovery from stroke has reached the third stage of the Brownstrong action stage or more The subject's cognitive function is normal; The muscle tension of the hemiplegic limb must be less than 3 on the modified Ashewurth scale Vibration or rehabilitation intervention can be performed for 1 hour under the balance of sitting posture Understand the experiment and agree Exclusion Criteria: This stroke is a recurrence The muscle tension of the hemiplegic limbs is too high and they are completely unable to exercise alone The patient has unilateral hemianopia or significant unilateral neglect in vision, which seriously affects the execution of physical movements Patients with vestibular, cerebellum and other diseases that seriously affect the execution of movements Patients with orthopedic or trauma and other factors that cause discomfort such as pain during evaluation or intervention Patients who are unable to communicate effectively due to cognitive abnormalities caused by stroke The patient has other related factors such as neurological and psychiatric diseases, which are affected by physical activity during the experiment
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chueh-Ho Lin, Ph.D.
    Phone
    +88627361661
    Ext
    6325
    Email
    chueh.ho@tmu.edu.tw
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jia-Lan CHANG, Master
    Phone
    +88622490088
    Ext
    1606
    Email
    08173@s.tmu.edu.tw
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chueh-Ho Lin, Ph.D.
    Organizational Affiliation
    250 Wu-Hsing Street, Taipei City, Taiwan 110, R.O.C.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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