Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 10:28 PM
Study NCT ID:
NCT07333456
Status:
COMPLETED
Last Update Posted:
2026-02-10
First Post:
2025-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Vibration on Lower Limb Muscle Strength, Functional Status, and Psychological Health in Stroke Patients
Sponsor:
Tri-Service General Hospital
Organization:
Study Overview
Official Title:
The Effects of Vibration on Lower Limb Muscle Strength, Functional Status, and Psychological Health in Stroke Patients.
Status:
COMPLETED
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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)
* 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)
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NSTC 112-2314-B-016-069 | OTHER_GRANT | Ministry of Science and Technology | View | |
| C202305047 | OTHER | Institutional Review Board of Tri-Service General Hospital, National Defense Medical Center | View | |
| C202105050 | OTHER | Institutional Review Board of Tri-Service General Hospital, National Defense Medical Center | View |