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EFFECT of WHOLE BODY VIBRATION on FUNCTIONAL CAPACITY and RESPIRATORY FUNCTIONS IN STROKE INDIVIDUALS

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ClinicalTrials.gov Identifier: NCT04548388
Recruitment Status : Completed
First Posted : September 14, 2020
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
Mehmet Duray, Suleyman Demirel University

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.

Condition or disease Intervention/treatment Phase
Stroke Respiratory Function Impaired Other: rehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: EFFECT of WHOLE BODY VIBRATION on FUNCTIONAL CAPACITY and RESPIRATORY FUNCTIONS IN STROKE INDIVIDUALS: A RANDOMIZED CONTROLLED STUDY
Actual Study Start Date : November 20, 2017
Actual Primary Completion Date : November 17, 2018
Actual Study Completion Date : November 30, 2018

Arm Intervention/treatment
Experimental: Bobath approach
Bobath approach
Other: rehabilitation

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


Experimental: whole body vibration
whole body vibration
Other: rehabilitation

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 Measures :
  1. Six-minute walking test [ Time Frame: 12 months ]
    functional capacity

  2. microQuark® brand PC-based USB spirometer [ Time Frame: 12 months ]
    respiratory capacity



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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04548388


Locations
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Turkey
Mehmet Duray
Isparta, Turkey, 32200
Sponsors and Collaborators
Suleyman Demirel University
Investigators
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Principal Investigator: Mehmet Duray Suleyman Demirel University
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Responsible Party: Mehmet Duray, Principal Investigator, Suleyman Demirel University
ClinicalTrials.gov Identifier: NCT04548388    
Other Study ID Numbers: 60116787-020/45178
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mehmet Duray, Suleyman Demirel University:
Stroke
Bobath approach
whole body vibration
functional capacity
respiratory function
Additional relevant MeSH terms:
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Respiratory Insufficiency
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases