Back to resultsEffectiveness of Vibration Training on Functional Recovery and Mood State Among Patients With Acute Stroke
Primary Purpose
Vibration; Exposure, Rehabilitation
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Vibration training
ergometer exercise
Sponsored by
About this trial
This is an interventional treatment trial for Vibration; Exposure
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.
Sites / Locations
- Chia-Huei LinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Placebo Comparator
Sham Comparator
Experimental
Arm Label
control group
exercise group
wearable leg vibration training group
lower-extremity weight bearing vibration training group
Arm 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.
The exercise group will receive extra 5 days of 30-minute lower-limb ergometer exercise training in addition to the conventional therapy.
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.
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.
Outcomes
Primary Outcome Measures
neurologic disability
neurologic disability will be assessed by Modified Rankin Scale, which scores are ranged from mRS: 0 (no symptoms) to 6 (death) and score 5 indicates a severe disability: requires constant nursing care and attention, bedridden, and incontinent.
neurologic disability
neurologic disability will be assessed by Modified Rankin Scale, which scores are ranged from mRS: 0 (no symptoms) to 6 (death) and score 5 indicates a severe disability: requires constant nursing care and attention, bedridden, and incontinent.
neurologic disability
neurologic disability will be assessed by Modified Rankin Scale, which scores are ranged from mRS: 0 (no symptoms) to 6 (death) and score 5 indicates a severe disability: requires constant nursing care and attention, bedridden, and incontinent.
muscle strength
The reliable and well-validated Medical Research Council Manual Muscle Testing scale, the most commonly accepted method of evaluating muscle strength and easy to perform, will be adopt to evaluate muscle strength. The scale assesses the lower-limb muscle strength of both affected and unaffected side by measuring the resisting gravity load and against the examiner's resistance. The test is scored on a scale of 0 - 5, with 0 indicating the worst muscle strength where no muscle contraction is observed, 1 indicating slight muscle contraction but no limb movement, 2 indicating parallel limb movement but no gravity resistance or lifting, 3 indicating limb movement against gravity, 4 indicating limb movement against slight resistance, and 5 indicating limb movement against moderate resistance.
muscle strength
The reliable and well-validated Medical Research Council Manual Muscle Testing scale, the most commonly accepted method of evaluating muscle strength and easy to perform, will be adopt to evaluate muscle strength. The scale assesses the lower-limb muscle strength of both affected and unaffected side by measuring the resisting gravity load and against the examiner's resistance. The test is scored on a scale of 0 - 5, with 0 indicating the worst muscle strength where no muscle contraction is observed, 1 indicating slight muscle contraction but no limb movement, 2 indicating parallel limb movement but no gravity resistance or lifting, 3 indicating limb movement against gravity, 4 indicating limb movement against slight resistance, and 5 indicating limb movement against moderate resistance.
muscle strength
The reliable and well-validated Medical Research Council Manual Muscle Testing scale, the most commonly accepted method of evaluating muscle strength and easy to perform, will be adopt to evaluate muscle strength. The scale assesses the lower-limb muscle strength of both affected and unaffected side by measuring the resisting gravity load and against the examiner's resistance. The test is scored on a scale of 0 - 5, with 0 indicating the worst muscle strength where no muscle contraction is observed, 1 indicating slight muscle contraction but no limb movement, 2 indicating parallel limb movement but no gravity resistance or lifting, 3 indicating limb movement against gravity, 4 indicating limb movement against slight resistance, and 5 indicating limb movement against moderate resistance.
Functional status: Postural Assessment Scale for Stroke
The Postural Assessment Scale for Stroke, consisting of two parts with a 4-point scale and a total score ranging from 0-36, is a well-validated assessment tool for postural control in patients with stroke during the first 3 months after stroke. The PASS will be used to evaluate patient's ability to either maintain posture (including static and dynamic balance) or change posture (switching between lying, sitting, and standing) and participants with higher scores represent a better functional status.
Functional status: Postural Assessment Scale for Stroke
The Postural Assessment Scale for Stroke, consisting of two parts with a 4-point scale and a total score ranging from 0-36, is a well-validated assessment tool for postural control in patients with stroke during the first 3 months after stroke. The PASS will be used to evaluate patient's ability to either maintain posture (including static and dynamic balance) or change posture (switching between lying, sitting, and standing) and participants with higher scores represent a better functional status.
Functional status: Postural Assessment Scale for Stroke
The Postural Assessment Scale for Stroke, consisting of two parts with a 4-point scale and a total score ranging from 0-36, is a well-validated assessment tool for postural control in patients with stroke during the first 3 months after stroke. The PASS will be used to evaluate patient's ability to either maintain posture (including static and dynamic balance) or change posture (switching between lying, sitting, and standing) and participants with higher scores represent a better functional status.
Functional status: Barthel Scale
The Barthel Scale, a reliable and well-validated daily life function scale and the most commonly used in long-term care to assess patients' physical functioning, which are highly correlated with the degree of individual disability, will be employed to evaluate the independent daily life function of participants. The scores of the scale with 10 items and several aspects, including eating, movement, personal hygiene, toileting, etc., ranged from 0-100. The higher the score, the better functioning and the more independent in their daily activities the patients have.
Functional status: Barthel Scale
The Barthel Scale, a reliable and well-validated daily life function scale and the most commonly used in long-term care to assess patients' physical functioning, which are highly correlated with the degree of individual disability, will be employed to evaluate the independent daily life function of participants. The scores of the scale with 10 items and several aspects, including eating, movement, personal hygiene, toileting, etc., ranged from 0-100. The higher the score, the better functioning and the more independent in their daily activities the patients have.
Functional status: Barthel Scale
The Barthel Scale, a reliable and well-validated daily life function scale and the most commonly used in long-term care to assess patients' physical functioning, which are highly correlated with the degree of individual disability, will be employed to evaluate the independent daily life function of participants. The scores of the scale with 10 items and several aspects, including eating, movement, personal hygiene, toileting, etc., ranged from 0-100. The higher the score, the better functioning and the more independent in their daily activities the patients have.
Mood state
This study will use the Hospital Anxiety and Depression Scale (HADS) to assess the participants' mood state. The reliable and well-validated tool has a total of 14 questions, with seven items related to anxiety (HSDS-A) and seven items related to depression (HADS-D). Each item of the HADS is scored from 0-3, and the total score of both subscales ranged from 0-21. The higher the score, the higher the degree of anxiety or depression of the participants had. A score above 8 indicates the presence of anxiety or depression.
Mood state
This study will use the Hospital Anxiety and Depression Scale (HADS) to assess the participants' mood state. The reliable and well-validated tool has a total of 14 questions, with seven items related to anxiety (HSDS-A) and seven items related to depression (HADS-D). Each item of the HADS is scored from 0-3, and the total score of both subscales ranged from 0-21. The higher the score, the higher the degree of anxiety or depression of the participants had. A score above 8 indicates the presence of anxiety or depression.
Mood state
This study will use the Hospital Anxiety and Depression Scale (HADS) to assess the participants' mood state. The reliable and well-validated tool has a total of 14 questions, with seven items related to anxiety (HSDS-A) and seven items related to depression (HADS-D). Each item of the HADS is scored from 0-3, and the total score of both subscales ranged from 0-21. The higher the score, the higher the degree of anxiety or depression of the participants had. A score above 8 indicates the presence of anxiety or depression.
Secondary Outcome Measures
Full Information
NCT ID
NCT05462028
First Posted
July 8, 2022
Last Updated
October 18, 2022
Sponsor
Tri-Service General Hospital
Collaborators
Ministry of Science and Technology, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT05462028
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tri-Service General Hospital
Collaborators
Ministry of Science and Technology, Taiwan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vibration; Exposure, Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The outcome data will be collected by a research assistant who was blinded in group assignment.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm 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.
Arm Title
exercise group
Arm Type
Placebo Comparator
Arm Description
The exercise group will receive extra 5 days of 30-minute lower-limb ergometer exercise training in addition to the conventional therapy.
Arm Title
wearable leg vibration training group
Arm Type
Sham Comparator
Arm 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.
Arm Title
lower-extremity weight bearing vibration training group
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Vibration training
Intervention Description
The vibration sessions were performed and supervised by a stroke care experienced registered nurses/researchers who had both nurse and physiotherapist license. The wearable leg vibration training with vibration frequency = 30 Hz, vibration amplitude = 1 mm in the WG was applied by the wearable leg vibration device (Myovolt, New Zealand) which fits comfortably around the knee and hamstring or calf and delivers focal vibration treatment. While the lower-extremity weight bearing vibration training with vibration frequency = 20 Hz, vibration amplitude = 3 mm in the LG was applied the Cozy Fit (HY-806, China) vibration device with vertical direction, which participants stand with both feet upright on the vibrator in a seated position.
Intervention Type
Behavioral
Intervention Name(s)
ergometer exercise
Intervention Description
ergometer exercise training
Primary Outcome Measure Information:
Title
neurologic disability
Description
neurologic disability will be assessed by Modified Rankin Scale, which scores are ranged from mRS: 0 (no symptoms) to 6 (death) and score 5 indicates a severe disability: requires constant nursing care and attention, bedridden, and incontinent.
Time Frame
Baseline
Title
neurologic disability
Description
neurologic disability will be assessed by Modified Rankin Scale, which scores are ranged from mRS: 0 (no symptoms) to 6 (death) and score 5 indicates a severe disability: requires constant nursing care and attention, bedridden, and incontinent.
Time Frame
5 days after intervention
Title
neurologic disability
Description
neurologic disability will be assessed by Modified Rankin Scale, which scores are ranged from mRS: 0 (no symptoms) to 6 (death) and score 5 indicates a severe disability: requires constant nursing care and attention, bedridden, and incontinent.
Time Frame
through hospitalization, an average of 14 days
Title
muscle strength
Description
The reliable and well-validated Medical Research Council Manual Muscle Testing scale, the most commonly accepted method of evaluating muscle strength and easy to perform, will be adopt to evaluate muscle strength. The scale assesses the lower-limb muscle strength of both affected and unaffected side by measuring the resisting gravity load and against the examiner's resistance. The test is scored on a scale of 0 - 5, with 0 indicating the worst muscle strength where no muscle contraction is observed, 1 indicating slight muscle contraction but no limb movement, 2 indicating parallel limb movement but no gravity resistance or lifting, 3 indicating limb movement against gravity, 4 indicating limb movement against slight resistance, and 5 indicating limb movement against moderate resistance.
Time Frame
Baseline
Title
muscle strength
Description
The reliable and well-validated Medical Research Council Manual Muscle Testing scale, the most commonly accepted method of evaluating muscle strength and easy to perform, will be adopt to evaluate muscle strength. The scale assesses the lower-limb muscle strength of both affected and unaffected side by measuring the resisting gravity load and against the examiner's resistance. The test is scored on a scale of 0 - 5, with 0 indicating the worst muscle strength where no muscle contraction is observed, 1 indicating slight muscle contraction but no limb movement, 2 indicating parallel limb movement but no gravity resistance or lifting, 3 indicating limb movement against gravity, 4 indicating limb movement against slight resistance, and 5 indicating limb movement against moderate resistance.
Time Frame
5 days after intervention
Title
muscle strength
Description
The reliable and well-validated Medical Research Council Manual Muscle Testing scale, the most commonly accepted method of evaluating muscle strength and easy to perform, will be adopt to evaluate muscle strength. The scale assesses the lower-limb muscle strength of both affected and unaffected side by measuring the resisting gravity load and against the examiner's resistance. The test is scored on a scale of 0 - 5, with 0 indicating the worst muscle strength where no muscle contraction is observed, 1 indicating slight muscle contraction but no limb movement, 2 indicating parallel limb movement but no gravity resistance or lifting, 3 indicating limb movement against gravity, 4 indicating limb movement against slight resistance, and 5 indicating limb movement against moderate resistance.
Time Frame
through hospitalization, an average of 14 days
Title
Functional status: Postural Assessment Scale for Stroke
Description
The Postural Assessment Scale for Stroke, consisting of two parts with a 4-point scale and a total score ranging from 0-36, is a well-validated assessment tool for postural control in patients with stroke during the first 3 months after stroke. The PASS will be used to evaluate patient's ability to either maintain posture (including static and dynamic balance) or change posture (switching between lying, sitting, and standing) and participants with higher scores represent a better functional status.
Time Frame
Baseline
Title
Functional status: Postural Assessment Scale for Stroke
Description
The Postural Assessment Scale for Stroke, consisting of two parts with a 4-point scale and a total score ranging from 0-36, is a well-validated assessment tool for postural control in patients with stroke during the first 3 months after stroke. The PASS will be used to evaluate patient's ability to either maintain posture (including static and dynamic balance) or change posture (switching between lying, sitting, and standing) and participants with higher scores represent a better functional status.
Time Frame
5 days after intervention
Title
Functional status: Postural Assessment Scale for Stroke
Description
The Postural Assessment Scale for Stroke, consisting of two parts with a 4-point scale and a total score ranging from 0-36, is a well-validated assessment tool for postural control in patients with stroke during the first 3 months after stroke. The PASS will be used to evaluate patient's ability to either maintain posture (including static and dynamic balance) or change posture (switching between lying, sitting, and standing) and participants with higher scores represent a better functional status.
Time Frame
through hospitalization, an average of 14 days
Title
Functional status: Barthel Scale
Description
The Barthel Scale, a reliable and well-validated daily life function scale and the most commonly used in long-term care to assess patients' physical functioning, which are highly correlated with the degree of individual disability, will be employed to evaluate the independent daily life function of participants. The scores of the scale with 10 items and several aspects, including eating, movement, personal hygiene, toileting, etc., ranged from 0-100. The higher the score, the better functioning and the more independent in their daily activities the patients have.
Time Frame
Baseline
Title
Functional status: Barthel Scale
Description
The Barthel Scale, a reliable and well-validated daily life function scale and the most commonly used in long-term care to assess patients' physical functioning, which are highly correlated with the degree of individual disability, will be employed to evaluate the independent daily life function of participants. The scores of the scale with 10 items and several aspects, including eating, movement, personal hygiene, toileting, etc., ranged from 0-100. The higher the score, the better functioning and the more independent in their daily activities the patients have.
Time Frame
5 days after intervention
Title
Functional status: Barthel Scale
Description
The Barthel Scale, a reliable and well-validated daily life function scale and the most commonly used in long-term care to assess patients' physical functioning, which are highly correlated with the degree of individual disability, will be employed to evaluate the independent daily life function of participants. The scores of the scale with 10 items and several aspects, including eating, movement, personal hygiene, toileting, etc., ranged from 0-100. The higher the score, the better functioning and the more independent in their daily activities the patients have.
Time Frame
through hospitalization, an average of 14 days
Title
Mood state
Description
This study will use the Hospital Anxiety and Depression Scale (HADS) to assess the participants' mood state. The reliable and well-validated tool has a total of 14 questions, with seven items related to anxiety (HSDS-A) and seven items related to depression (HADS-D). Each item of the HADS is scored from 0-3, and the total score of both subscales ranged from 0-21. The higher the score, the higher the degree of anxiety or depression of the participants had. A score above 8 indicates the presence of anxiety or depression.
Time Frame
Baseline
Title
Mood state
Description
This study will use the Hospital Anxiety and Depression Scale (HADS) to assess the participants' mood state. The reliable and well-validated tool has a total of 14 questions, with seven items related to anxiety (HSDS-A) and seven items related to depression (HADS-D). Each item of the HADS is scored from 0-3, and the total score of both subscales ranged from 0-21. The higher the score, the higher the degree of anxiety or depression of the participants had. A score above 8 indicates the presence of anxiety or depression.
Time Frame
5 days after intervention
Title
Mood state
Description
This study will use the Hospital Anxiety and Depression Scale (HADS) to assess the participants' mood state. The reliable and well-validated tool has a total of 14 questions, with seven items related to anxiety (HSDS-A) and seven items related to depression (HADS-D). Each item of the HADS is scored from 0-3, and the total score of both subscales ranged from 0-21. The higher the score, the higher the degree of anxiety or depression of the participants had. A score above 8 indicates the presence of anxiety or depression.
Time Frame
through hospitalization, an average of 14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chia-Huei Lin, PhD
Phone
+886920328195
Email
andyy520@mail.ndmctsgh.edu.tw
Facility Information:
Facility Name
Chia-Huei Lin
City
Taipei
State/Province
Hawaii
ZIP/Postal Code
11105
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chia-Huei Lin, PhD
Phone
+8862785116
Email
andyy520@yahoo.com.tw
First Name & Middle Initial & Last Name & Degree
Shang-Lin Chiang, PhD
Phone
+8862785116
Email
andyyy520@yahoo.com.tw
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of Vibration Training on Functional Recovery and Mood State Among Patients With Acute Stroke
We'll reach out to this number within 24 hrs