NCT04548388

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2018

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
Last Updated

September 14, 2020

Status Verified

September 1, 2020

Enrollment Period

12 months

First QC Date

September 8, 2020

Last Update Submit

September 8, 2020

Conditions

Keywords

StrokeBobath approachwhole body vibrationfunctional capacityrespiratory function

Outcome Measures

Primary Outcomes (2)

  • Six-minute walking test

    functional capacity

    12 months

  • microQuark® brand PC-based USB spirometer

    respiratory capacity

    12 months

Study Arms (2)

Bobath approach

EXPERIMENTAL

Bobath approach

Other: rehabilitation

whole body vibration

EXPERIMENTAL

whole body vibration

Other: rehabilitation

Interventions

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

Bobath approachwhole body vibration

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • having any neurological, psychiatric, orthopedic and unstable cardiovascular and pulmonary conditions other than stroke.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mehmet Duray

Isparta, 32200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

StrokeRespiratory InsufficiencyRespiratory Aspiration

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Mehmet Duray

    Suleyman Demirel University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 8, 2020

First Posted

September 14, 2020

Study Start

November 20, 2017

Primary Completion

November 17, 2018

Study Completion

November 30, 2018

Last Updated

September 14, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations