StrokeNCT07333456
The Effects of Vibration on Lower Limb Muscle Strength, Functional Status, and Psychological Health in Stroke Patients
A study testing wearable vibration, vertical vibration and early rehabilitation in people with Stroke, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to the effect of vibration training on lower limb muscle strength, functional status and psychological health of stroke patients. The main questions it aims to answer are: Lower limb muscle strength was measured using the Medical Research Council Manual Strength Test. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- wearable vibration, vertical vibration and early rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Jan 2022to 26 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized with a diagnosis of acute ischemic stroke (cerebral infarction).
- Stroke onset occurred within three days of admission.
- Age between 20 and 80 years old.
- Ability to communicate verbally or non-verbally and understand Mandarin or Taiwanese.
- Normal cognitive function (MMSE ≥ 21).
- Disability level assessed as 1-4 on the modified Rankin Scale (mRS)
- Willingness to participate in the study and agree to random group allocation.
Who cannot join
- Diagnosed with transient ischemic attack (TIA) accompanied by vision or hearing impairments.
- Disability level of mRS ≥ 5 (severe disability requiring bedridden care).
- Acute or chronic neurological or musculoskeletal injuries in the lower limbs or history of joint surgery within the past six months.
- Presence of a pacemaker.
- Unstable or significant cardiovascular or cardiac disease, cancer history, end-stage renal disease requiring hemodialysis, or diagnosed psychiatric disorders, especially depression.
- Patients transferred from other hospital wards or intensive care units.
- Hospitalization exceeding 21 days due to other medical or surgical conditions (e.g., infections) or hospitalization shortened to fewer than seven days due to hospital transfers or seeking alternative therapies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Vibration on Lower Limb Muscle Strength, Functional Status, and Psychological Health in Stroke Patients.
The goal of this clinical trial is to the effect of vibration training on lower limb muscle strength, functional status and psychological health of stroke patients. The main questions it aims to answer are:
- Lower limb muscle strength was measured using the Medical Research Council Manual Strength Test.
- Functional status was measured using Postural Assessment Scale for Stroke, and the Barthel scale.
- Psychological health was measured using the Hospital Anxiety and Depression Scale.
Read more
Participants will be randomly assigned to four groups:
- Control group: Receives only rehabilitation training and standard treatment.
- Comparison group: Receives rehabilitation training, standard treatment, and a 30-minute stationary cycling intervention during hospitalization for 5 days.
- Experimental group 1: Receives rehabilitation training, standard treatment, and a 30-minute wearable lower-limb high-frequency, low-amplitude vibration therapy during hospitalization for 5 days, followed by 30 minutes of stationary cycling.
- Experimental group 2: Receives rehabilitation training, standard treatment, and a 30-minute vertical lower-limb low-frequency, high-amplitude vibration therapy during hospitalization for 5 days, followed by 30 minutes of stationary cycling.
All participants will undergo an initial measurement within 4 hours of admission, followed by the second and third measurements after the 5-day intervention and on the day of discharge, respectively.
Read the detailed description
Standard care for all study participants includes conventional rehabilitation therapy for stroke. This therapy involves physical therapy (e.g., posture training, endurance training, muscle strength training) and occupational therapy provided at the rehabilitation center. Such rehabilitation typically begins 3-6 days after admission and is administered by a physical or occupational therapist.
- Control group: Receives only standard stroke treatment and rehabilitation therapy.
- Comparison group: Additionally, using stationary lower leg pedal bike (WP-698) with moderate intensity.
- Experimental group 1: In addition to standard rehabilitation, participants receive 5 days of stationary cycling training combined with localized vibration therapy with a wearable vibration device (Myovolt).
- Experimental group 2: In addition to standard rehabilitation, participants receive 5 days of stationary cycling training combined with vertical vibration therapy for the lower limbs with COZY FIT vertical vibration machine (HY-806-BK)
- Conditions
- Stroke
- Being tested
- wearable vibration, vertical vibration, early rehabilitation, regular treatment
- Keywords
- stroke, early rehabilitation, vibration, Lower limb muscle strength, Functional status, Psychological health
- Medical subject headings
- Stroke, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wearable vibrationBehavioural
Also called early rehabilitation
In addition to standard rehabilitation, participants receive 5 days of stationary cycling training combined with localized vibration therapy administered using a wearable vibration device. Vibration parameters are set at a frequency of 30 Hz and amplitude of 1 mm, targeting the lower-leg muscle groups. Each session lasts 30 minutes and begins within 1-2 days of admission.
vertical vibrationBehavioural
Also called early rehabilitation
In addition to standard rehabilitation, participants receive 5 days of stationary cycling training combined with vertical vibration therapy for the lower limbs. Vibration parameters are set at a frequency of 20 Hz and amplitude of 3 mm. Each session also lasts 30 minutes and begins within 1-2 days of admission.
early rehabilitationBehavioural
In addition to standard stroke treatment, participants receive 5 days of stationary cycling training in the acute stroke unit beginning 1-2 days after admission (at least 24 hours after the stroke onset). The cycling session lasts approximately 30 minutes, including a 5-minute warm-up, 20-minute training session, and 5-minute cool-down.
regular treatmentBehavioural
Receives only standard stroke treatment and rehabilitation therapy.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Receives only standard stroke treatment and rehabilitation therapy. Receives: Behavioral: regular treatment |
| Stationary cycling training | Experimental | In addition to standard stroke treatment, participants receive 5 days of stationary cycling training in the acute stroke unit beginning 1-2 days after admission (at least 24 hours after the stroke onset). The cycling session lasts approximately 30 minutes, including a 5-minute warm-up, 20-minute training session, and 5-minute cool-down. Receives: Behavioral: early rehabilitation; Behavioral: regular treatment |
| Stationary cycling training combined with localized vibration therapy | Experimental | In addition to standard rehabilitation, participants receive 5 days of stationary cycling training combined with localized vibration therapy administered using a wearable vibration device. Vibration parameters are set at a frequency of 30 Hz and amplitude of 1 mm, targeting the lower-leg muscle groups. Each session lasts 30 minutes and begins within 1-2 days of admission. Receives: Behavioral: wearable vibration; Behavioral: early rehabilitation; Behavioral: regular treatment |
| Stationary cycling training combined with vertical vibration therapy | Experimental | In addition to standard rehabilitation, participants receive 5 days of stationary cycling training combined with vertical vibration therapy for the lower limbs. Vibration parameters are set at a frequency of 20 Hz and amplitude of 3 mm. Each session also lasts 30 minutes and begins within 1-2 days of admission. Receives: Behavioral: vertical vibration; Behavioral: early rehabilitation; Behavioral: regular treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower-limb muscle strength
Using the Medical Research Council Manual Strength Test. Muscle strength was assessed by evaluating the ability of the limbs to move against gravity or applied resistance, using a grading scale ranging from 0 to 5. Higher scores indicate better muscle strength. A score of 0 indicates no visible or palpable muscle contraction; 1 indicates only visible or palpable muscle contraction; 2 indicates joint movement with gravity eliminated; 3 indicates observable joint movement against gravity but not against resistance; 4 indicates joint movement against gravity with some resistance; and 5 indicates joint movement with full resistance against both gravity and applied resistance.
Measured: All participants will undergo an initial measurement within 4 hours of admission, followed by the second and third measurements after the 5-day intervention and on the day of discharge, an average of 11 days , respectively.
Functional status
Using Postural Assessment Scale for Stroke, and the Barthel scale. The scale consists of 12 items and is scored using a four-point scale (0-1-2-3), with a total score ranging from 0 to 36. Higher scores indicate better postural control and balance function. It primarily assesses two domains: (1) stability of body posture, including static and dynamic balance, and (2) the ability to change body positions, encompa Barthel scale: The scale primarily assesses activities of daily living, including feeding, grooming, toileting, bathing, dressing, bowel and bladder control, transfers between a wheelchair and bed, walking on a level surface or wheelchair propulsion, and stair climbing. The total score ranges from 0 to 100. Scores of 0-20 indicate complete dependence, 21-60 indicate severe dependence, 61-90 indicate moderate dependence, 91-99 indicate slight dependence, and a score of 100 indicates independence. Higher scores reflect better self-care ability and a higher level of independence.
Measured: All participants will undergo an initial measurement within 4 hours of admission, followed by the second and third measurements after the 5-day intervention and on the day of discharge, an average of 11 days, respectively.
Psychological health
Using the Hospital Anxiety and Depression Scale. This scale focuses on the assessment of emotional symptoms and consists of 14 items, including 7 items for anxiety and 7 items for depression. It uses a four-point Likert-type scoring system, with some items reverse scored. The total score ranges from 0 to 42, with the anxiety subscale ranging from 0 to 21 and the depression subscale ranging from 0 to 21. Higher scores indicate more pronounced anxiety or depressive symptoms. Subscale scores of ≤7 indicate no anxiety or depression, scores of 8-10 indicate possible anxiety or depression, and scores of ≥11 indicate the presence of anxiety or depression.
Measured: All participants will undergo an initial measurement within 4 hours of admission, followed by the second and third measurements after the 5-day intervention and on the day of discharge, an average of 11 days, respectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start14 Jan 2022
- Primary completion26 Apr 2025
- Study completion26 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Principal investigator, Yu-Jung Tseng, National Defense Medical Center, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333456
- Sponsor's protocol ID
- YJTseng
- Other IDs
- NSTC 112-2314-B-016-069, C202305047, C202105050
- Status last verified
- Feb 2026
- First submitted
- 29 Sep 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Vibration on Lower Limb Muscle Strength, Functional Status, and Psychological Health in Stroke Patients.
- ClinicalTrials.gov ID
- NCT07333456
- Acronym / sponsor ID
- YJTseng
- Conditions
- Stroke
- Keywords
- stroke, early rehabilitation, vibration, Lower limb muscle strength, Functional status, Psychological health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 26 Apr 2025 (actual)
- Study completion
- 26 Apr 2025 (actual)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to the effect of vibration training on lower limb muscle strength, functional status and psychological health of stroke patients. The main questions it aims to answer are:
- Lower limb muscle strength was measured using the Medical Research Council Manual Strength Test.
- Functional status was measured using Postural Assessment Scale for Stroke, and the Barthel scale.
- Psychological health was measured using the Hospital Anxiety and Depression Scale.
Participants will be randomly assigned to four groups:
- Control group: Receives only rehabilitation training and standard treatment.
- Comparison group: Receives rehabilitation training, standard treatment, and a 30-minute stationary cycling intervention during hospitalization for 5 days.
- Experimental group 1: Receives rehabilitation training, standard treatment, and a 30-minute wearable lower-limb high-frequency, low-amplitude vibration therapy during hospitalization for 5 days, followed by 30 minutes of stationary cycling.
- Experimental group 2: Receives rehabilitation training, standard treatment, and a 30-minute vertical lower-limb low-frequency, high-amplitude vibration therapy during hospitalization for 5 days, followed by 30 minutes of stationary cycling.
All participants will undergo an initial measurement within 4 hours of admission, followed by the second and third measurements after the 5-day intervention and on the day of discharge, respectively.
Detailed description
Standard care for all study participants includes conventional rehabilitation therapy for stroke. This therapy involves physical therapy (e.g., posture training, endurance training, muscle strength training) and occupational therapy provided at the rehabilitation center. Such rehabilitation typically begins 3-6 days after admission and is administered by a physical or occupational therapist.
- Control group: Receives only standard stroke treatment and rehabilitation therapy.
- Comparison group: Additionally, using stationary lower leg pedal bike (WP-698) with moderate intensity.
- Experimental group 1: In addition to standard rehabilitation, participants receive 5 days of stationary cycling training combined with localized vibration therapy with a wearable vibration device (Myovolt).
- Experimental group 2: In addition to standard rehabilitation, participants receive 5 days of stationary cycling training combined with vertical vibration therapy for the lower limbs with COZY FIT vertical vibration machine (HY-806-BK)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Behavioral: regular treatmentReceives only standard stroke treatment and rehabilitation therapy. |
| Stationary cycling training | Experimental | Behavioral: early rehabilitation, Behavioral: regular treatmentIn addition to standard stroke treatment, participants receive 5 days of stationary cycling training in the acute stroke unit beginning 1-2 days after admission (at least 24 hours after the stroke onset). The cycling session lasts approximately 30 minutes, including a 5-minute warm-up, 20-minute training session, and 5-minute cool-down. |
| Stationary cycling training combined with localized vibration therapy | Experimental | Behavioral: wearable vibration, Behavioral: early rehabilitation, Behavioral: regular treatmentIn addition to standard rehabilitation, participants receive 5 days of stationary cycling training combined with localized vibration therapy administered using a wearable vibration device. Vibration parameters are set at a frequency of 30 Hz and amplitude of 1 mm, targeting the lower-leg muscle groups. Each session lasts 30 minutes and begins within 1-2 days of admission. |
| Stationary cycling training combined with vertical vibration therapy | Experimental | Behavioral: vertical vibration, Behavioral: early rehabilitation, Behavioral: regular treatmentIn addition to standard rehabilitation, participants receive 5 days of stationary cycling training combined with vertical vibration therapy for the lower limbs. Vibration parameters are set at a frequency of 20 Hz and amplitude of 3 mm. Each session also lasts 30 minutes and begins within 1-2 days of admission. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Hospitalized with a diagnosis of acute ischemic stroke (cerebral infarction).
- Stroke onset occurred within three days of admission.
- Age between 20 and 80 years old.
- Ability to communicate verbally or non-verbally and understand Mandarin or Taiwanese.
- Normal cognitive function (MMSE ≥ 21).
Key exclusion criteria (7 listed)
- Diagnosed with transient ischemic attack (TIA) accompanied by vision or hearing impairments.
- Disability level of mRS ≥ 5 (severe disability requiring bedridden care).
- Acute or chronic neurological or musculoskeletal injuries in the lower limbs or history of joint surgery within the past six months.
- Presence of a pacemaker.
- Unstable or significant cardiovascular or cardiac disease, cancer history, end-stage renal disease requiring hemodialysis, or diagnosed psychiatric disorders, especially depression.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wearable vibrationAlso: early rehabilitationIn addition to standard rehabilitation, participants receive 5 days of stationary cycling training combined with localized vibration therapy administered using a wearable vibration device. Vibration parameters are set at a frequency of 30 Hz and amplitude of 1 mm, targeting the lower-leg muscle groups. Each session lasts 30 minutes and begins within 1-2 days of admission. | Behavioural | Stationary cycling training combined with localized vibration therapy |
| vertical vibrationAlso: early rehabilitationIn addition to standard rehabilitation, participants receive 5 days of stationary cycling training combined with vertical vibration therapy for the lower limbs. Vibration parameters are set at a frequency of 20 Hz and amplitude of 3 mm. Each session also lasts 30 minutes and begins within 1-2 days of admission. | Behavioural | Stationary cycling training combined with vertical vibration therapy |
| early rehabilitationIn addition to standard stroke treatment, participants receive 5 days of stationary cycling training in the acute stroke unit beginning 1-2 days after admission (at least 24 hours after the stroke onset). The cycling session lasts approximately 30 minutes, including a 5-minute warm-up, 20-minute training session, and 5-minute cool-down. | Behavioural | Stationary cycling training, Stationary cycling training combined with localized vibration therapy, Stationary cycling training combined with vertical vibration therapy |
| regular treatmentReceives only standard stroke treatment and rehabilitation therapy. | Behavioural | Control group, Stationary cycling training, Stationary cycling training combined with localized vibration therapy, Stationary cycling training combined with vertical vibration therapy |
Primary outcome
Lower-limb muscle strength
Time frame: All participants will undergo an initial measurement within 4 hours of admission, followed by the second and third measurements after the 5-day intervention and on the day of discharge, an average of 11 days , respectively.
Using the Medical Research Council Manual Strength Test. Muscle strength was assessed by evaluating the ability of the limbs to move against gravity or applied resistance, using a grading scale ranging from 0 to 5. Higher scores indicate better muscle strength. A score of 0 indicates no visible or palpable muscle contraction; 1 indicates only visible or palpable muscle contraction; 2 indicates joint movement with gravity eliminated; 3 indicates observable joint movement against gravity but not against resistance; 4 indicates joint movement against gravity with some resistance; and 5 indicates joint movement with full resistance against both gravity and applied resistance.
Functional status
Time frame: All participants will undergo an initial measurement within 4 hours of admission, followed by the second and third measurements after the 5-day intervention and on the day of discharge, an average of 11 days, respectively.
Using Postural Assessment Scale for Stroke, and the Barthel scale. The scale consists of 12 items and is scored using a four-point scale (0-1-2-3), with a total score ranging from 0 to 36. Higher scores indicate better postural control and balance function. It primarily assesses two domains: (1) stability of body posture, including static and dynamic balance, and (2) the ability to change body positions, encompa Barthel scale: The scale primarily assesses activities of daily living, including feeding, grooming, toileting, bathing, dressing, bowel and bladder control, transfers between a wheelchair and bed, walking on a level surface or wheelchair propulsion, and stair climbing. The total score ranges from 0 to 100. Scores of 0-20 indicate complete dependence, 21-60 indicate severe dependence, 61-90 indicate moderate dependence, 91-99 indicate slight dependence, and a score of 100 indicates independence. Higher scores reflect better self-care ability and a higher level of independence.
Psychological health
Time frame: All participants will undergo an initial measurement within 4 hours of admission, followed by the second and third measurements after the 5-day intervention and on the day of discharge, an average of 11 days, respectively.
Using the Hospital Anxiety and Depression Scale. This scale focuses on the assessment of emotional symptoms and consists of 14 items, including 7 items for anxiety and 7 items for depression. It uses a four-point Likert-type scoring system, with some items reverse scored. The total score ranges from 0 to 42, with the anxiety subscale ranging from 0 to 21 and the depression subscale ranging from 0 to 21. Higher scores indicate more pronounced anxiety or depressive symptoms. Subscale scores of ≤7 indicate no anxiety or depression, scores of 8-10 indicate possible anxiety or depression, and scores of ≥11 indicate the presence of anxiety or depression.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wearable vibration, vertical vibration and early rehabilitation in people with Stroke, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower-limb muscle strength (time frame: All participants will undergo an initial measurement within 4 hours of admission, followed by the second and third measurements after the 5-day intervention and on the day of discharge, an average of 11 days , respectively.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.