Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NSTC 112-2314-B-016-069 | Other Grant/Funding Number | Ministry of Science and Technology | |
| C202305047 | Other Identifier | Institutional Review Board of Tri-Service General Hospital, National Defense Medical Center | |
| C202105050 | Other Identifier | Institutional Review Board of Tri-Service General Hospital, National Defense Medical Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Science and Technology Council, Taiwan | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
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:
Participants will be randomly assigned to four groups:
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Receives only standard stroke treatment and rehabilitation therapy. |
|
| Stationary cycling training | Experimental | 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. |
|
| Stationary cycling training combined with localized vibration therapy | Experimental | 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. |
|
| Stationary cycling training combined with vertical vibration therapy | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| wearable vibration | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Lower-limb muscle strength | Using the Medical Research Council Manual Strength Test. Muscle strength was assessed by evaluating the ability of the limbs to move against gravity or applied resistance, using a grading scale ranging from 0 to 5. Higher scores indicate better muscle strength. A score of 0 indicates no visible or palpable muscle contraction; 1 indicates only visible or palpable muscle contraction; 2 indicates joint movement with gravity eliminated; 3 indicates observable joint movement against gravity but not against resistance; 4 indicates joint movement against gravity with some resistance; and 5 indicates joint movement with full resistance against both gravity and applied resistance. | 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, an average of 11 days , respectively. |
| Functional status | Using Postural Assessment Scale for Stroke, and the Barthel scale. The scale consists of 12 items and is scored using a four-point scale (0-1-2-3), with a total score ranging from 0 to 36. Higher scores indicate better postural control and balance function. It primarily assesses two domains: (1) stability of body posture, including static and dynamic balance, and (2) the ability to change body positions, encompa Barthel scale: The scale primarily assesses activities of daily living, including feeding, grooming, toileting, bathing, dressing, bowel and bladder control, transfers between a wheelchair and bed, walking on a level surface or wheelchair propulsion, and stair climbing. The total score ranges from 0 to 100. Scores of 0-20 indicate complete dependence, 21-60 indicate severe dependence, 61-90 indicate moderate dependence, 91-99 indicate slight dependence, and a score of 100 indicates independence. Higher scores reflect better self-care ability and a higher level of independence. | 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, an average of 11 days, respectively. |
| Psychological health | Using the Hospital Anxiety and Depression Scale. This scale focuses on the assessment of emotional symptoms and consists of 14 items, including 7 items for anxiety and 7 items for depression. It uses a four-point Likert-type scoring system, with some items reverse scored. The total score ranges from 0 to 42, with the anxiety subscale ranging from 0 to 21 and the depression subscale ranging from 0 to 21. Higher scores indicate more pronounced anxiety or depressive symptoms. Subscale scores of ≤7 indicate no anxiety or depression, scores of 8-10 indicate possible anxiety or depression, and scores of ≥11 indicate the presence of anxiety or depression. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TriServiceGH | Taipei | Neihu Dist | 114202 | Taiwan |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
|
| vertical vibration | 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. |
|
|
| early rehabilitation | 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 | Behavioral | Receives only standard stroke treatment and rehabilitation therapy. |
|
| 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, an average of 11 days, respectively. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |