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

Tri-Service General Hospital

Status: Completed

Conditions: Stroke

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07333456

NSTC 112-2314-B-016-069 (Other Grant/Funding Number)

YJTseng

C202305047 (Other Identifier)

C202105050

Details and patient eligibility

About

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.

Full 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)

Enrollment: 115 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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115 participants in 4 patient groups

Control group

Experimental group

Description:

Receives only standard stroke treatment and rehabilitation therapy.

Treatment:

Behavioral: regular treatment

Comparison group

Experimental group

Description:

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.

Treatment:

Behavioral: regular treatment

Behavioral: early rehabilitation

Experimental group 1

Experimental group

Description:

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.

Treatment:

Behavioral: regular treatment

Behavioral: wearable vibration

Experimental group 2

Experimental group

Description:

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.

Treatment:

Behavioral: vertical vibration

Behavioral: regular treatment