Back to resultsShort-Term Effects of Whole-Body Vibration on Upper Extremity Function in Subjects With Poststroke Hemiplegia
Primary Purpose
Rehabilitation, Stroke, Hemiplegia
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
whole-body vibration training
conventional upper limb training
Sponsored by
About this trial
This is an interventional treatment trial for Rehabilitation focused on measuring Whole-Body vibration, Stroke, Hemiplegia, upper extremity, Rehabilitation training, Muscular surface EMG, Vibration training
Eligibility Criteria
Inclusion Criteria:
- After unilateral stroke 1 to 6 months
- An ischemic or hemorrhagic poststroke hemiplegia
- No cognitive impairment
- Able to reach Brunnstrom stage II or above in the proximal and distal parts of the arms
- No excessive pain in the more affected upper extremity
- All subjects agreed to participate in the study after receiving explanations regarding the purpose and procedures of the experiment, and they signed an informed consent statement before participation
Exclusion Criteria:
- Unsteadiness
- Accompanied by important organs (such as heart, liver, lung, kidney) dysfunction or malignant tumors
- Contraindications to general vibration training exist
- Combined with other diseases causing upper limb dysfunction
Sites / Locations
- Peking Univercity Third HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
control group
whole-body vibration group
Arm Description
Over a 3-week period, the subjects in the control group received 1 hour daily of conventional upper limb training 5 times a week,including compensatory techniques for activities of daily living, UE strength, therapist-guided techniques for facilitating normal UE movement patterns,and range of motion and traditional positioning
Subjects in the whole-body vibration group received half an hour of daily conventional upper limb training, followed by whole-body vibration training for an additional half hour per day,5 days per week during a 3-week period
Outcomes
Primary Outcome Measures
upper-extremity Fugl-Meyer Scale
the assessment is scored by summing item ratings and reporting the aggregate score out of 66 points,with higher scores representing a greater UE motor ability summing item ratings and reporting the aggregate score out of 66 points, with higher scores representing a greater UE motor ability
Wolf Motor Function Test
participants were timed as they completed 15 activities that progressively involved more difficult arm movements and interactions with objects such as lifting a soda can, stacking checkers, and folding a towel. We reported the average time to perform the 15 items and the evaluator rated the normalcy of these items with a 6-point ordinal scale (range,0-5) using the functional ability scale.
Surface electromyography
Surface electromyography was used to measure the integrated EMG（IEMG）of the biceps and triceps during maximum isometric voluntary contraction（MIVC）of the affected elbow flexion and extension and then the co-contraction rate（CR）was calculated
Secondary Outcome Measures
Full Information
NCT ID
NCT03963258
First Posted
December 4, 2018
Last Updated
July 1, 2019
Sponsor
Peking University Third Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03963258
Brief Title
Short-Term Effects of Whole-Body Vibration on Upper Extremity Function in Subjects With Poststroke Hemiplegia
Official Title
Short-Term Effects of Whole-Body Vibration on Upper Extremity Function in Subjects With Poststroke Hemiplegia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2019 (Actual)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
May 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Third Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To investigate the effect of whole body vibration on upper limb motor function in hemiplegic patients with subacute stroke
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rehabilitation, Stroke, Hemiplegia, Physical Therapy Modalities, Electromyography, Upper Extremity, Recovery of Function, Vibration
Keywords
Whole-Body vibration, Stroke, Hemiplegia, upper extremity, Rehabilitation training, Muscular surface EMG, Vibration training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Over a 3-week period, the subjects in the control group received 1 hour daily of conventional upper limb training 5 times a week,including compensatory techniques for activities of daily living, UE strength, therapist-guided techniques for facilitating normal UE movement patterns,and range of motion and traditional positioning
Arm Title
whole-body vibration group
Arm Type
Experimental
Arm Description
Subjects in the whole-body vibration group received half an hour of daily conventional upper limb training, followed by whole-body vibration training for an additional half hour per day,5 days per week during a 3-week period
Intervention Type
Device
Intervention Name(s)
whole-body vibration training
Other Intervention Name(s)
vibration training
Intervention Description
The subjects were exposed to alternating vertical sinusoidal vibration using a Galileo tilting table system.The frequency of WBV ranged from 5 to 20 Hz, and the amplitude ranged from 1 to 6 mm.The subjects were kneeled on the ground, both shoulders flexed at 90 degrees, elbows slightly flexed, their trunk bent in this position and contacted on the platform board with their palms equidistant from the midpoint of the board
Intervention Type
Other
Intervention Name(s)
conventional upper limb training
Intervention Description
compensatory techniques for activities of daily living, UE strength, therapist-guided techniques for facilitating normal UE movement patterns,and range of motion and traditional positioning
Primary Outcome Measure Information:
Title
upper-extremity Fugl-Meyer Scale
Description
the assessment is scored by summing item ratings and reporting the aggregate score out of 66 points,with higher scores representing a greater UE motor ability summing item ratings and reporting the aggregate score out of 66 points, with higher scores representing a greater UE motor ability
Time Frame
After the 3-week intervention period
Title
Wolf Motor Function Test
Description
participants were timed as they completed 15 activities that progressively involved more difficult arm movements and interactions with objects such as lifting a soda can, stacking checkers, and folding a towel. We reported the average time to perform the 15 items and the evaluator rated the normalcy of these items with a 6-point ordinal scale (range,0-5) using the functional ability scale.
Time Frame
After the 3-week intervention period
Title
Surface electromyography
Description
Surface electromyography was used to measure the integrated EMG（IEMG）of the biceps and triceps during maximum isometric voluntary contraction（MIVC）of the affected elbow flexion and extension and then the co-contraction rate（CR）was calculated
Time Frame
After the 3-week intervention period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
After unilateral stroke 1 to 6 months
An ischemic or hemorrhagic poststroke hemiplegia
No cognitive impairment
Able to reach Brunnstrom stage II or above in the proximal and distal parts of the arms
No excessive pain in the more affected upper extremity
All subjects agreed to participate in the study after receiving explanations regarding the purpose and procedures of the experiment, and they signed an informed consent statement before participation
Exclusion Criteria:
Unsteadiness
Accompanied by important organs (such as heart, liver, lung, kidney) dysfunction or malignant tumors
Contraindications to general vibration training exist
Combined with other diseases causing upper limb dysfunction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mouwang zhou, master
Phone
13910092892
Email
zhoumouwang@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
hongbo Li, bachelor
Phone
17778025997
Email
1184455890@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mouwang zhou, master
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Univercity Third Hospital
City
Beijing
State/Province
No State Or Province
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongbo Li, bachelor
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Short-Term Effects of Whole-Body Vibration on Upper Extremity Function in Subjects With Poststroke Hemiplegia
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