The Effects of Vibration on Lower Limb Muscle Strength, Functional Status, and Psychological Health in Stroke Patients

NCT07333456 | Completed DMC

• 4 other identifiers: YJTsengNSTC 112-2314-B-016-069C202305047C202105050
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief 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.
• 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.

Conditions

Stroke

Keywords

stroke; early rehabilitation; vibration; Lower limb muscle strength; Functional status; Psychological health

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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.

Study Arms (4)

Control group

ACTIVE COMPARATOR

Receives only standard stroke treatment and rehabilitation therapy.

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.

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.

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.

Behavioral: vertical vibration; Behavioral: early rehabilitation; Behavioral: regular treatment

Interventions

early rehabilitation BEHAVIORAL

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.

Stationary cycling training; Stationary cycling training combined with localized vibration therapy; Stationary cycling training combined with vertical vibration therapy

regular treatment BEHAVIORAL

Receives only standard stroke treatment and rehabilitation therapy.

Control group; Stationary cycling training; Stationary cycling training combined with localized vibration therapy; Stationary cycling training combined with vertical vibration therapy

wearable vibration BEHAVIORAL

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.

Also known as: early rehabilitation

Stationary cycling training combined with localized vibration therapy

vertical vibration BEHAVIORAL

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.

Also known as: early rehabilitation

Stationary cycling training combined with vertical vibration therapy

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tri-Service General Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

TriServiceGH

Taipei, Neihu Dist, 114202, Taiwan

Location

MeSH Terms

Conditions

Stroke; Psychological Well-Being

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: January 12, 2026
• Study Start: January 14, 2022
• Primary Completion: April 26, 2025
• Study Completion: April 26, 2025
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TW (1)