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Completed

NCT Number: NCT03974490

Effect of RAS on Balance and Gait After Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Gait Disorders, Neurologic Gait, Hemiplegic Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Sociosanitari Mutuam Girona

Girona, 17007, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Rhythmic Auditory Stimulation

Other

Rhythmic auditory stimulation 3 times in a week, and 2 hours of physiotherapy 6 days in a week.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospital Sociosanitari Mutuam Girona

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 5, 2019
Registry last updated
Apr 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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