Clinical trial NCT03974490: Effect of RAS on Balance and Gait After Stroke
Official title: Effect of Rhythmic Auditory Stimulation on Balance and Gait Parameters in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Gait, Hemiplegic
Gait Disorders, Neurologic
Keywords: rhythm
musicotherapy
balance
gait
stroke
physiotherapy
Lead sponsor: Hospital Sociosanitari Mutuam Girona
Sponsor class: OTHER
First posted: 2019-06-05
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Balance
timeFrame: At baseline, 20 days after baseline and 40 days after baseline
measure: Balance
timeFrame: At baseline, 20 days and 40 days after baseline
measure: Gait
timeFrame: At baseline, 20 days after baseline and 40 days after baseline
measure: Gait
timeFrame: At baseline, 20 days and 40 days after baseline
measure: Gait parameters
timeFrame: At baseline, 20 days after baseline and 40 days after baseline
measure: Gait parameters
timeFrame: At baseline, 20 days and 40 days after baseline
measure: Gait parameters
timeFrame: At baseline, 20 days after baseline and 40 days after baseline
measure: Gait Functionality
timeFrame: At baseline and 40 days after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Girona
country: Spain
facility: Hospital Sociosanitari Mutuam Girona
Study officials:
affiliation: Hospital Sociosanitari Mutuam Girona
name: Samira Gonzalez
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gonzalez-Hoelling S, Bertran-Noguer C, Reig-Garcia G, Suner-Soler R. Effects of a Music-Based Rhythmic Auditory Stimulation on Gait and Balance in Subacute Stroke. Int J Environ Res Public Health. 2021 Feb 19;18(4):2032. doi: 10.3390/ijerph18042032.