Effectiveness of Vibration Training on Functional Recovery and Mood State Among Patients With Acute Stroke
NCT ID: NCT05462028
Last Updated: 2022-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2022-08-01
2023-07-31
Brief Summary
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Detailed Description
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Therefore, this study aims to exam the effectiveness of vibration training on muscle strength of lower limbs, functional recovery, and mood state among patients with acute stroke.
A randomized controlled trial will be conducted. Patients with acute ischemic stroke will be selected and randomly assigned to either control group (CG), exercise group (EG), wearable leg vibration training group (WG), or lower extremity vibration training group (LG). All groups will receive conventional treatment and regular rehabilitation. Neurologic disability (Modified Rankin Scale), muscle strength, functional status (Postural Assessment Scale and Barthel Scale), and mood state (Hospital Anxiety and Depression Scale) will be collected to compare between groups and pre- and post-differences.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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control group
Only received conventional therapy comprised of standardized treatment and regular rehabilitation (i.e., postural training, facilitation techniques, stretching exercise, and strengthening exercise) prescribed by a rehabilitation physician and performed at 3 to 6 days after admission for five 60-minute sessions per week by the physical, occupational, and speech therapists in the rehabilitation center of the medical center.
No interventions assigned to this group
exercise group
The exercise group will receive extra 5 days of 30-minute lower-limb ergometer exercise training in addition to the conventional therapy.
ergometer exercise
ergometer exercise training
wearable leg vibration training group
The wearable leg vibration training group will receive extra 5 days of 30-minute wearable leg vibration of lower limbs combined with 30-minute lower-limb ergometer exercise training at post-vibration session, in addition to the conventional therapy.
Vibration training
The vibration sessions were performed and supervised by a stroke care experienced registered nurses/researchers who had both nurse and physiotherapist license. The wearable leg vibration training with vibration frequency = 30 Hz, vibration amplitude = 1 mm in the WG was applied by the wearable leg vibration device (Myovolt, New Zealand) which fits comfortably around the knee and hamstring or calf and delivers focal vibration treatment. While the lower-extremity weight bearing vibration training with vibration frequency = 20 Hz, vibration amplitude = 3 mm in the LG was applied the Cozy Fit (HY-806, China) vibration device with vertical direction, which participants stand with both feet upright on the vibrator in a seated position.
ergometer exercise
ergometer exercise training
lower-extremity weight bearing vibration training group
The lower-extremity weight bearing vibration training group will receive extra 5 days of 30-minute lower-extremity weight bearing vibration combined with30-minute lower-limb ergometer exercise training at post-vibration session, in addition to the conventional therapy.
Vibration training
The vibration sessions were performed and supervised by a stroke care experienced registered nurses/researchers who had both nurse and physiotherapist license. The wearable leg vibration training with vibration frequency = 30 Hz, vibration amplitude = 1 mm in the WG was applied by the wearable leg vibration device (Myovolt, New Zealand) which fits comfortably around the knee and hamstring or calf and delivers focal vibration treatment. While the lower-extremity weight bearing vibration training with vibration frequency = 20 Hz, vibration amplitude = 3 mm in the LG was applied the Cozy Fit (HY-806, China) vibration device with vertical direction, which participants stand with both feet upright on the vibrator in a seated position.
ergometer exercise
ergometer exercise training
Interventions
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Vibration training
The vibration sessions were performed and supervised by a stroke care experienced registered nurses/researchers who had both nurse and physiotherapist license. The wearable leg vibration training with vibration frequency = 30 Hz, vibration amplitude = 1 mm in the WG was applied by the wearable leg vibration device (Myovolt, New Zealand) which fits comfortably around the knee and hamstring or calf and delivers focal vibration treatment. While the lower-extremity weight bearing vibration training with vibration frequency = 20 Hz, vibration amplitude = 3 mm in the LG was applied the Cozy Fit (HY-806, China) vibration device with vertical direction, which participants stand with both feet upright on the vibrator in a seated position.
ergometer exercise
ergometer exercise training
Eligibility Criteria
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Inclusion Criteria
* (2) stroke onset occurs within three days of admission;
* (3) aged greater than 20 years and under 80 years;
* (4) able to communicate with verbal or nonverbal methods and understand Mandarin;
* (5) normal cognitive function (Mini-Mental State Examination≥ 21);
* (6) neurologic disability ranged from 1 (able to execute all usual duties and activities despite some symptoms) to 4 (moderately severe , eg., unable to attend to own bodily needs without assistance, and unable to walk unassisted) score evaluated by the modified Rankin Scale (mRS);
* (7) agreed to be randomly assigned
Exclusion Criteria
* (2) neurologic disability were mRS: 0 (no symptoms) or 5 score (severe disability: requires constant nursing care and attention, bedridden, incontinent) and above;
* (3) an acute/chronic nerve or musculoskeletal injury in lower limbs, or history of bone and joint surgery of low extremities in the past six months;
* (4) a history of cancer, end-stage renal disease with dialysis, dementia, mental health disorders (particularly major depression), based on both of medical records and assessments from the neurologist;
* (5) patients transferred from other wards or intensive care units;
* (6) being unable to participate due to other comorbid neurological and musculoskeletal conditions that produce moderate-to-severe physical disability;
* (7) prolonged stay in hospital for over 21 days due to other medical comorbidities (e.g., myocardial infarction, septic shock, cancer) after admission or length of stay in hospital less than one week due to a decline to treatment and transfer to another hospital for further confirmation of diagnosis and other complementary and alternative therapies.
20 Years
80 Years
ALL
No
Sponsors
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Ministry of Science and Technology, Taiwan
OTHER_GOV
Tri-Service General Hospital
OTHER
Responsible Party
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CHIA-HUEI LIN, PhD
Associate Professor
Locations
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Chia-Huei Lin
Taipei, Hawaii, Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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C202105050
Identifier Type: -
Identifier Source: org_study_id
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