Effect of RAS on Balance and Gait After Stroke

Not Applicable

Completed

• Conditions: Gait Disorders, Neurologic; Stroke; Gait, Hemiplegic
• Interventions: Other: Rhythmic auditory stimulation

• Registration Number: NCT03974490
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2019-04-11
• Study First Submitted QC: 2019-06-03
• Study First Posted: 2019-06-05
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-22
• Last Update Posted: 2020-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Rhythmic auditory stimulation	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.

Primary Outcome Measures

Name	Time	Method
Gait	At baseline, 20 days and 40 days after baseline	Change in gait using the Timed Up\&Go Test
Gait parameters	At baseline, 20 days after baseline and 40 days after baseline	Change in cadence using a stopwatch
Balance	At baseline, 20 days and 40 days after baseline	Change in balance using the Tinetti Test
Gait Functionality	At baseline and 40 days after baseline	Change in gait functionality using the Functional Ambulatory Category

Trial Locations

Locations (1)

Hospital Sociosanitari Mutuam Girona; 🇪🇸 Girona, Spain