Effectiveness of Vibration Training on Functional Recovery and Mood State Among Patients With Acute Stroke

NCT05462028 | Completed DMC

• 1 other identifier: C202105050
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vibration; Exposure; Rehabilitation

Outcome Measures

Primary Outcomes (15)

• neurologic disability

  neurologic disability will be assessed by Modified Rankin Scale, which scores are ranged from mRS: 0 (no symptoms) to 6 (death) and score 5 indicates a severe disability: requires constant nursing care and attention, bedridden, and incontinent.

  Baseline

• neurologic disability

  neurologic disability will be assessed by Modified Rankin Scale, which scores are ranged from mRS: 0 (no symptoms) to 6 (death) and score 5 indicates a severe disability: requires constant nursing care and attention, bedridden, and incontinent.

  5 days after intervention

• neurologic disability

  neurologic disability will be assessed by Modified Rankin Scale, which scores are ranged from mRS: 0 (no symptoms) to 6 (death) and score 5 indicates a severe disability: requires constant nursing care and attention, bedridden, and incontinent.

  through hospitalization, an average of 14 days

• muscle strength

  The reliable and well-validated Medical Research Council Manual Muscle Testing scale, the most commonly accepted method of evaluating muscle strength and easy to perform, will be adopt to evaluate muscle strength. The scale assesses the lower-limb muscle strength of both affected and unaffected side by measuring the resisting gravity load and against the examiner's resistance. The test is scored on a scale of 0 - 5, with 0 indicating the worst muscle strength where no muscle contraction is observed, 1 indicating slight muscle contraction but no limb movement, 2 indicating parallel limb movement but no gravity resistance or lifting, 3 indicating limb movement against gravity, 4 indicating limb movement against slight resistance, and 5 indicating limb movement against moderate resistance.

  Baseline

• muscle strength

  The reliable and well-validated Medical Research Council Manual Muscle Testing scale, the most commonly accepted method of evaluating muscle strength and easy to perform, will be adopt to evaluate muscle strength. The scale assesses the lower-limb muscle strength of both affected and unaffected side by measuring the resisting gravity load and against the examiner's resistance. The test is scored on a scale of 0 - 5, with 0 indicating the worst muscle strength where no muscle contraction is observed, 1 indicating slight muscle contraction but no limb movement, 2 indicating parallel limb movement but no gravity resistance or lifting, 3 indicating limb movement against gravity, 4 indicating limb movement against slight resistance, and 5 indicating limb movement against moderate resistance.

  5 days after intervention

• muscle strength

  The reliable and well-validated Medical Research Council Manual Muscle Testing scale, the most commonly accepted method of evaluating muscle strength and easy to perform, will be adopt to evaluate muscle strength. The scale assesses the lower-limb muscle strength of both affected and unaffected side by measuring the resisting gravity load and against the examiner's resistance. The test is scored on a scale of 0 - 5, with 0 indicating the worst muscle strength where no muscle contraction is observed, 1 indicating slight muscle contraction but no limb movement, 2 indicating parallel limb movement but no gravity resistance or lifting, 3 indicating limb movement against gravity, 4 indicating limb movement against slight resistance, and 5 indicating limb movement against moderate resistance.

  through hospitalization, an average of 14 days

• Functional status: Postural Assessment Scale for Stroke

  The Postural Assessment Scale for Stroke, consisting of two parts with a 4-point scale and a total score ranging from 0-36, is a well-validated assessment tool for postural control in patients with stroke during the first 3 months after stroke. The PASS will be used to evaluate patient's ability to either maintain posture (including static and dynamic balance) or change posture (switching between lying, sitting, and standing) and participants with higher scores represent a better functional status.

  Baseline

• Functional status: Postural Assessment Scale for Stroke

  The Postural Assessment Scale for Stroke, consisting of two parts with a 4-point scale and a total score ranging from 0-36, is a well-validated assessment tool for postural control in patients with stroke during the first 3 months after stroke. The PASS will be used to evaluate patient's ability to either maintain posture (including static and dynamic balance) or change posture (switching between lying, sitting, and standing) and participants with higher scores represent a better functional status.

  5 days after intervention

• Functional status: Postural Assessment Scale for Stroke

  The Postural Assessment Scale for Stroke, consisting of two parts with a 4-point scale and a total score ranging from 0-36, is a well-validated assessment tool for postural control in patients with stroke during the first 3 months after stroke. The PASS will be used to evaluate patient's ability to either maintain posture (including static and dynamic balance) or change posture (switching between lying, sitting, and standing) and participants with higher scores represent a better functional status.

  through hospitalization, an average of 14 days

• Functional status: Barthel Scale

  The Barthel Scale, a reliable and well-validated daily life function scale and the most commonly used in long-term care to assess patients' physical functioning, which are highly correlated with the degree of individual disability, will be employed to evaluate the independent daily life function of participants. The scores of the scale with 10 items and several aspects, including eating, movement, personal hygiene, toileting, etc., ranged from 0-100. The higher the score, the better functioning and the more independent in their daily activities the patients have.

  Baseline

• Functional status: Barthel Scale

  The Barthel Scale, a reliable and well-validated daily life function scale and the most commonly used in long-term care to assess patients' physical functioning, which are highly correlated with the degree of individual disability, will be employed to evaluate the independent daily life function of participants. The scores of the scale with 10 items and several aspects, including eating, movement, personal hygiene, toileting, etc., ranged from 0-100. The higher the score, the better functioning and the more independent in their daily activities the patients have.

  5 days after intervention

• Functional status: Barthel Scale

  The Barthel Scale, a reliable and well-validated daily life function scale and the most commonly used in long-term care to assess patients' physical functioning, which are highly correlated with the degree of individual disability, will be employed to evaluate the independent daily life function of participants. The scores of the scale with 10 items and several aspects, including eating, movement, personal hygiene, toileting, etc., ranged from 0-100. The higher the score, the better functioning and the more independent in their daily activities the patients have.

  through hospitalization, an average of 14 days

• Mood state

  This study will use the Hospital Anxiety and Depression Scale (HADS) to assess the participants' mood state. The reliable and well-validated tool has a total of 14 questions, with seven items related to anxiety (HSDS-A) and seven items related to depression (HADS-D). Each item of the HADS is scored from 0-3, and the total score of both subscales ranged from 0-21. The higher the score, the higher the degree of anxiety or depression of the participants had. A score above 8 indicates the presence of anxiety or depression.

  Baseline

• Mood state

  This study will use the Hospital Anxiety and Depression Scale (HADS) to assess the participants' mood state. The reliable and well-validated tool has a total of 14 questions, with seven items related to anxiety (HSDS-A) and seven items related to depression (HADS-D). Each item of the HADS is scored from 0-3, and the total score of both subscales ranged from 0-21. The higher the score, the higher the degree of anxiety or depression of the participants had. A score above 8 indicates the presence of anxiety or depression.

  5 days after intervention

• Mood state

  This study will use the Hospital Anxiety and Depression Scale (HADS) to assess the participants' mood state. The reliable and well-validated tool has a total of 14 questions, with seven items related to anxiety (HSDS-A) and seven items related to depression (HADS-D). Each item of the HADS is scored from 0-3, and the total score of both subscales ranged from 0-21. The higher the score, the higher the degree of anxiety or depression of the participants had. A score above 8 indicates the presence of anxiety or depression.

  through hospitalization, an average of 14 days

Study Arms (4)

control group

NO INTERVENTION

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.

exercise group

PLACEBO COMPARATOR

The exercise group will receive extra 5 days of 30-minute lower-limb ergometer exercise training in addition to the conventional therapy.

Behavioral: ergometer exercise

wearable leg vibration training group

SHAM COMPARATOR

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.

Device: Vibration training; Behavioral: ergometer exercise

lower-extremity weight bearing vibration training group

EXPERIMENTAL

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.

Device: Vibration training; Behavioral: ergometer exercise

Interventions

Vibration training DEVICE

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.

lower-extremity weight bearing vibration training group; wearable leg vibration training group

ergometer exercise BEHAVIORAL

ergometer exercise training

exercise group; lower-extremity weight bearing vibration training group; wearable leg vibration training group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) inpatients diagnosed with acute infarct (ischemic, e.g., large artery atherosclerosis, cardioembolism, and small vessel occlusion) stroke;
• (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

You may not qualify if:

• (1) diagnosed with a transient ischemic attack combined with visual and hearing impairment;
• (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.

Sponsors & Collaborators

• Tri-Service General Hospital: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

Chia-Huei Lin

Taipei, Hawaii, 11105, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome data will be collected by a research assistant who was blinded in group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: July 18, 2022
• Study Start: January 17, 2022
• Primary Completion: April 13, 2025
• Study Completion: July 31, 2025
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)