Effect of RAS on Balance and Gait After Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03974490
• Other study ID #: Mutuam_Girona_04_19
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: April 2020
• Source: Hospital Sociosanitari Mutuam Girona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Gait, Hemiplegic
• Nervous System Diseases
• Stroke

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Sociosanitari Mutuam Girona	Girona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Sociosanitari Mutuam Girona

Country where clinical trial is conducted

Spain, 

Outcome

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