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

Tri-Service General Hospital

Status: Enrolling

Conditions: Rehabilitation; Vibration; Exposure

Treatments: Device: Vibration training; Behavioral: ergometer exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05462028

C202105050

Details and patient eligibility

About

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.

Full description

There remains challenging for improving functional recovery of stroke patients in the acute post-stroke period among patients with acute stroke. Particularly the effectiveness of early rehabilitation combining with vibration training for patients with acute stroke is unknown.

Therefore, 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.

A randomized controlled trial will be conducted. Patients with acute ischemic stroke will be selected and randomly assigned to either control group (CG), exercise group (EG), wearable leg vibration training group (WG), or lower extremity vibration training group (LG). All groups will receive conventional treatment and regular rehabilitation. Neurologic disability (Modified Rankin Scale), muscle strength, functional status (Postural Assessment Scale and Barthel Scale), and mood state (Hospital Anxiety and Depression Scale) will be collected to compare between groups and pre- and post-differences.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• (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

Exclusion criteria

• (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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 4 patient groups, including a placebo group

control group

No Intervention group

Description:

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 group

Description:

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

Treatment:

Behavioral: ergometer exercise

wearable leg vibration training group

Sham Comparator group

Description:

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.

Treatment:

Behavioral: ergometer exercise

Device: Vibration training

lower-extremity weight bearing vibration training group

Experimental group

Description:

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.

Treatment:

Behavioral: ergometer exercise

Device: Vibration training