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

EFFECT of WHOLE BODY VIBRATION on FUNCTIONAL CAPACITY and RESPIRATORY FUNCTIONS IN STROKE INDIVIDUALS: A RANDOMIZED CONTROLLED STUDY

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Respiratory Function Impaired
• Intervention / Treatment: Other: rehabilitation

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Isparta, Turkey, 32200
    • Mehmet Duray

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six-minute walking test	functional capacity	12 months
microQuark® brand PC-based USB spirometer	respiratory capacity	12 months

Collaborators and Investigators

• Sponsor: Suleyman Demirel University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 20, 2017
• Primary Completion (ACTUAL): November 17, 2018
• Study Completion (ACTUAL): November 30, 2018

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: September 8, 2020
• First Posted (ACTUAL): September 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 14, 2020
• Last Update Submitted That Met QC Criteria: September 8, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Stroke; functional capacity; whole body vibration; respiratory function; Bobath approach
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Stroke; Respiratory Insufficiency
• Other Study ID Numbers: 60116787-020/45178

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No