Clinical trial NCT05462028: Effectiveness of Vibration Training on Functional Recovery and Mood State Among Patients With Acute Stroke
Official title: Effectiveness of Vibration Training on Muscle Strength of Lower Limbs, Functional Recovery, and Mood State Among Patients With Acute Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vibration; Exposure
Rehabilitation
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2022-07-18
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: neurologic disability
timeFrame: Baseline
measure: neurologic disability
timeFrame: 5 days after intervention
measure: neurologic disability
timeFrame: through hospitalization, an average of 14 days
measure: muscle strength
timeFrame: Baseline
measure: muscle strength
timeFrame: 5 days after intervention
measure: muscle strength
timeFrame: through hospitalization, an average of 14 days
measure: Functional status: Postural Assessment Scale for Stroke
timeFrame: Baseline
measure: Functional status: Postural Assessment Scale for Stroke
timeFrame: 5 days after intervention
measure: Functional status: Postural Assessment Scale for Stroke
timeFrame: through hospitalization, an average of 14 days
measure: Functional status: Barthel Scale
timeFrame: Baseline
measure: Functional status: Barthel Scale
timeFrame: 5 days after intervention
measure: Functional status: Barthel Scale
timeFrame: through hospitalization, an average of 14 days
measure: Mood state
timeFrame: Baseline
measure: Mood state
timeFrame: 5 days after intervention
measure: Mood state
timeFrame: through hospitalization, an average of 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Chia-Huei Lin
state: Hawaii
Study officials:
References: