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

NCT ID: NCT07333456

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-14
• Study Completion Date: 2025-04-26

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:

1. Control group: Receives only rehabilitation training and standard treatment.

2. Comparison group: Receives rehabilitation training, standard treatment, and a 30-minute stationary cycling intervention during hospitalization for 5 days.

3. 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.

4. 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)

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Control group

Receives only standard stroke treatment and rehabilitation therapy.

Group Type: EXPERIMENTAL

regular treatment

Intervention Type: BEHAVIORAL

Receives only standard stroke treatment and rehabilitation therapy.

Comparison group

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.

Group Type: EXPERIMENTAL

early rehabilitation

Intervention Type: 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.

regular treatment

Intervention Type: BEHAVIORAL

Receives only standard stroke treatment and rehabilitation therapy.

Experimental group 1

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.

Group Type: EXPERIMENTAL

wearable vibration

Intervention Type: 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.

regular treatment

Intervention Type: BEHAVIORAL

Receives only standard stroke treatment and rehabilitation therapy.

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. 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.

Group Type: EXPERIMENTAL

vertical vibration

Intervention Type: 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.

regular treatment

Intervention Type: BEHAVIORAL

Receives only standard stroke treatment and rehabilitation therapy.

Interventions

wearable vibration

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.

Intervention Type: BEHAVIORAL

vertical vibration

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.

Intervention Type: BEHAVIORAL

early rehabilitation

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.

Intervention Type: BEHAVIORAL

regular treatment

Receives only standard stroke treatment and rehabilitation therapy.

Intervention Type: BEHAVIORAL

Other Intervention Names

early rehabilitation; early rehabilitation

Eligibility Criteria

Inclusion Criteria

1. Hospitalized with a diagnosis of acute ischemic stroke (cerebral infarction).

2. Stroke onset occurred within three days of admission.

3. Age between 20 and 80 years old.

4. Ability to communicate verbally or non-verbally and understand Mandarin or Taiwanese.

5. Normal cognitive function (MMSE ≥ 21).

6. Disability level assessed as 1-4 on the modified Rankin Scale (mRS)

7. Willingness to participate in the study and agree to random group allocation.

Exclusion Criteria

1. Diagnosed with transient ischemic attack (TIA) accompanied by vision or hearing impairments.

2. Disability level of mRS ≥ 5 (severe disability requiring bedridden care).

3. Acute or chronic neurological or musculoskeletal injuries in the lower limbs or history of joint surgery within the past six months.

4. Presence of a pacemaker.

5. Unstable or significant cardiovascular or cardiac disease, cancer history, end-stage renal disease requiring hemodialysis, or diagnosed psychiatric disorders, especially depression.

6. Patients transferred from other hospital wards or intensive care units.

7. 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

Tri-Service General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yu-Jung Tseng

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

TriServiceGH

Taipei, Neihu Dist, Taiwan

Countries

Taiwan

Other Identifiers

NSTC 112-2314-B-016-069

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

C202305047

Identifier Type: OTHER

Identifier Source: secondary_id

C202105050

Identifier Type: OTHER

Identifier Source: secondary_id

YJTseng

Identifier Type: -

Identifier Source: org_study_id