Effect of RAS on Balance and Gait After Stroke

April 22, 2020 updated by: Samira Gonzalez Hoelling, Hospital Sociosanitari Mutuam Girona

Effect of Rhythmic Auditory Stimulation on Balance and Gait Parameters in Stroke Patients

A rhythmic auditory stimulation intervention may be beneficial in order to improve movement parameters after stroke. Reviews argue that more randomized controlled trials with a control group are needed. Main objective: Evaluate the effect of a rhythmic auditory stimulation on the quality of balance and gait parameters in people with stroke. Methodology: quasi-experimental study. The study has been approved by the hospital ethics committee.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A rhythmic auditory stimulation (RAS) intervention may be beneficial in order to improve the parameters of the post-stroke movement: increase of the speed of the walk, improvement in the width of the step with the affected side, improvement of the walking index dynamics (Dynamic Gait Index), improvement in cadence and improvement in the static balance.

Current systematic reviews argue that more randomized controlled trials with a control group are needed.

Main objective: To evaluate the effect of a rhythmic auditory stimulation on the quality of progress and balance in people with stroke.

Methodology: experimental group will be done between 2019 and 2020 and historical control group of the years 2017 and 2018. Experimental group will do 3 sessions in a week of RAS, and daily 2 hours of physiotherapy except of Sundays. Control group received 2 hours daily of physiotherapy, except Sundays.

The study has been approved by the hospital ethics committee.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Girona, Spain, 17007
        • Hospital Sociosanitari Mutuam Girona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Had a stroke in the last 3 weeks
  • Rankin 3-4
  • Barthel before stroke: >85
  • Tinetti < 23

Exclusion Criteria:

  • Patient can walk independently (Functional Ambulation Category >3)
  • Global and/or mixed aphasia
  • Glasgow < 10
  • Mini-Mental State Examination < 24
  • Posterior cerebral artery stroke
  • Gait and/or balance disorders before stroke (parkinsons disease, neurodegenerative diseases)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group

2 hours from Monday to Saturday, conventional physiotherapy: strengthening, stretching, dual task training.

3 Times a week, intervention: Start with global body warming, 15 minutes, following the rhythm marked by the metronome. Central part of the session, 60 minutes, with rhythmic auditory stimulation exercises and music. Closure of the session, 15 minutes, round of impressions.
Other: Rhythmic auditory stimulation
Rhythmic auditory stimulation 3 times in a week, and 2 hours of physiotherapy 6 days in a week.
No Intervention: Historical control group
2 hours from Monday to Saturday, conventional physiotherapy: strengthening, stretching, dual task training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Balance
Time Frame: At baseline, 20 days after baseline and 40 days after baseline
Change in balance using the Mini Best Test
At baseline, 20 days after baseline and 40 days after baseline
Balance
Time Frame: At baseline, 20 days and 40 days after baseline
Change in balance using the Tinetti Test
At baseline, 20 days and 40 days after baseline
Gait
Time Frame: At baseline, 20 days after baseline and 40 days after baseline
Change in gait using the Tinetti Test
At baseline, 20 days after baseline and 40 days after baseline
Gait
Time Frame: At baseline, 20 days and 40 days after baseline
Change in gait using the Timed Up&Go Test
At baseline, 20 days and 40 days after baseline
Gait parameters
Time Frame: At baseline, 20 days after baseline and 40 days after baseline
Change in step length using a measure tape
At baseline, 20 days after baseline and 40 days after baseline
Gait parameters
Time Frame: At baseline, 20 days and 40 days after baseline
Change in stride length using a measure tape
At baseline, 20 days and 40 days after baseline
Gait parameters
Time Frame: At baseline, 20 days after baseline and 40 days after baseline
Change in cadence using a stopwatch
At baseline, 20 days after baseline and 40 days after baseline
Gait Functionality
Time Frame: At baseline and 40 days after baseline
Change in gait functionality using the Functional Ambulatory Category
At baseline and 40 days after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Sociosanitari Mutuam Girona

Investigators

  • Principal Investigator: Samira Gonzalez, Hospital Sociosanitari Mutuam Girona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

January 31, 2020

Study Completion (Actual)

January 31, 2020

Study Registration Dates

First Submitted

April 11, 2019

First Submitted That Met QC Criteria

June 3, 2019

First Posted (Actual)

June 5, 2019

Study Record Updates

Last Update Posted (Actual)

April 24, 2020

Last Update Submitted That Met QC Criteria

April 22, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mutuam_Girona_04_19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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