EFFECT of WHOLE BODY VIBRATION on FUNCTIONAL CAPACITY and RESPIRATORY FUNCTIONS IN STROKE INDIVIDUALS
Primary Purpose
Stroke, Respiratory Function Impaired
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, Bobath approach, whole body vibration, functional capacity, respiratory function
Eligibility Criteria
Inclusion Criteria:
- having first hemiplegic stroke history at least for 3 months, being clinically stable could stand for at least 1 minute, could walk independently with or without a walking aids.
Exclusion Criteria:
- having any neurological, psychiatric, orthopedic and unstable cardiovascular and pulmonary conditions other than stroke.
Sites / Locations
- Mehmet Duray
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Bobath approach
whole body vibration
Arm Description
Bobath approach
whole body vibration
Outcomes
Primary Outcome Measures
Six-minute walking test
functional capacity
microQuark® brand PC-based USB spirometer
respiratory capacity
Secondary Outcome Measures
Full Information
NCT ID
NCT04548388
First Posted
September 8, 2020
Last Updated
September 8, 2020
Sponsor
Suleyman Demirel University
1. Study Identification
Unique Protocol Identification Number
NCT04548388
Brief Title
EFFECT of WHOLE BODY VIBRATION on FUNCTIONAL CAPACITY and RESPIRATORY FUNCTIONS IN STROKE INDIVIDUALS
Official Title
EFFECT of WHOLE BODY VIBRATION on FUNCTIONAL CAPACITY and RESPIRATORY FUNCTIONS IN STROKE INDIVIDUALS: A RANDOMIZED CONTROLLED STUDY
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
November 20, 2017 (Actual)
Primary Completion Date
November 17, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Suleyman Demirel University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
While there is only one study examining the effect of WBV on oxygen consumption and cardiovascular responses in individuals with stroke, no study has been found on the effect of WBV on respiratory capacity and flow volumes and changes in functional capacity due to effort. In this study, it was aimed to investigate whether the WBV treatment protocol determined has an effect on functional capacity and respiratory functions in individuals with stroke.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Respiratory Function Impaired
Keywords
Stroke, Bobath approach, whole body vibration, functional capacity, respiratory function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bobath approach
Arm Type
Experimental
Arm Description
Bobath approach
Arm Title
whole body vibration
Arm Type
Experimental
Arm Description
whole body vibration
Intervention Type
Other
Intervention Name(s)
rehabilitation
Intervention Description
A specialist physiotherapist in neurological rehabilitation provided the Bobath approach individually to each patients in both groups. Bobath approach included 3 days a week over a total of 12 sessions for four weeks. The Bobath approach consisted of about individual one hour session.
In addition to the Bobath approach, the subjects in the study group received WBV for 20 minutes a day, 2 days a week. The frequency of the device was increased by 5 Hz every week, starting the treatment with 30 Hz. Whole body vibration application was performed on a platform (Power Plate Pro5®) that provides vertical vibration. Two different practice positions were chosen as standing and semi-squatting. In order to prevent muscle fatigue, the set consisting of 1 minute of application - 1 minute of rest in each position was applied for a total of 10 minutes with 5 repetitions
Primary Outcome Measure Information:
Title
Six-minute walking test
Description
functional capacity
Time Frame
12 months
Title
microQuark® brand PC-based USB spirometer
Description
respiratory capacity
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
having first hemiplegic stroke history at least for 3 months, being clinically stable could stand for at least 1 minute, could walk independently with or without a walking aids.
Exclusion Criteria:
having any neurological, psychiatric, orthopedic and unstable cardiovascular and pulmonary conditions other than stroke.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet Duray
Organizational Affiliation
Suleyman Demirel University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mehmet Duray
City
Isparta
ZIP/Postal Code
32200
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
EFFECT of WHOLE BODY VIBRATION on FUNCTIONAL CAPACITY and RESPIRATORY FUNCTIONS IN STROKE INDIVIDUALS
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