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Effect of RAS on Balance and Gait After Stroke

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ClinicalTrials.gov Identifier: NCT03974490
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Samira Gonzalez Hoelling, Hospital Sociosanitari Mutuam Girona

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stroke Gait, Hemiplegic Gait Disorders, Neurologic Other: Rhythmic auditory stimulation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Rhythmic Auditory Stimulation on Balance and Gait Parameters in Stroke Patients
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : September 2020

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.



Primary Outcome Measures :
  1. Balance [ Time Frame: At baseline, 20 days after baseline and 40 days after baseline ]
    Change in balance using the Mini Best Test

  2. Balance [ Time Frame: At baseline, 20 days and 40 days after baseline ]
    Change in balance using the Tinetti Test

  3. Gait [ Time Frame: At baseline, 20 days after baseline and 40 days after baseline ]
    Change in gait using the Tinetti Test

  4. Gait [ Time Frame: At baseline, 20 days and 40 days after baseline ]
    Change in gait using the Timed Up&Go Test

  5. Gait parameters [ Time Frame: At baseline, 20 days after baseline and 40 days after baseline ]
    Change in step length using a measure tape

  6. Gait parameters [ Time Frame: At baseline, 20 days and 40 days after baseline ]
    Change in stride length using a measure tape

  7. Gait parameters [ Time Frame: At baseline, 20 days after baseline and 40 days after baseline ]
    Change in cadence using a stopwatch

  8. Gait Functionality [ Time Frame: At baseline and 40 days after baseline ]
    Change in gait functionality using the Functional Ambulatory Category



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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): NCT03974490


Contacts
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Contact: Samira Gonzalez 0034687660822 samira.gonzalez@mutuam.com

Locations
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Spain
Hospital Sociosanitari Mutuam Girona Recruiting
Girona, Spain, 17007
Contact: Samira Gonzalez    0034972171819 ext 2778    samira.gonzalez@mutuam.com   
Contact: Mireia Bosch    0034972171819 ext 2702    mbosch@mutuam.com   
Sponsors and Collaborators
Hospital Sociosanitari Mutuam Girona
Investigators
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Principal Investigator: Samira Gonzalez Hospital Sociosanitari Mutuam Girona

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Responsible Party: Samira Gonzalez Hoelling, Principal Investigator, Physiotherapist, Hospital Sociosanitari Mutuam Girona
ClinicalTrials.gov Identifier: NCT03974490     History of Changes
Other Study ID Numbers: Mutuam_Girona_04_19
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019

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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 Samira Gonzalez Hoelling, Hospital Sociosanitari Mutuam Girona:
rhythm
musicotherapy
balance
gait
stroke
physiotherapy

Additional relevant MeSH terms:
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Stroke
Gait Disorders, Neurologic
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms