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Effect of RAS on Balance and Gait After Stroke

Primary Purpose

Stroke, Gait, Hemiplegic, Gait Disorders, Neurologic

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Rhythmic auditory stimulation
Sponsored by
Hospital Sociosanitari Mutuam Girona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring rhythm, musicotherapy, balance, gait, stroke, physiotherapy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hospital Sociosanitari Mutuam Girona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Historical control group

Arm Description

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.

2 hours from Monday to Saturday, conventional physiotherapy: strengthening, stretching, dual task training.

Outcomes

Primary Outcome Measures

Balance
Change in balance using the Mini Best Test
Balance
Change in balance using the Tinetti Test
Gait
Change in gait using the Tinetti Test
Gait
Change in gait using the Timed Up&Go Test
Gait parameters
Change in step length using a measure tape
Gait parameters
Change in stride length using a measure tape
Gait parameters
Change in cadence using a stopwatch
Gait Functionality
Change in gait functionality using the Functional Ambulatory Category

Secondary Outcome Measures

Full Information

First Posted
April 11, 2019
Last Updated
April 22, 2020
Sponsor
Hospital Sociosanitari Mutuam Girona
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1. Study Identification

Unique Protocol Identification Number
NCT03974490
Brief Title
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

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
January 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Sociosanitari Mutuam Girona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Gait, Hemiplegic, Gait Disorders, Neurologic
Keywords
rhythm, musicotherapy, balance, gait, stroke, physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Historical control group
Arm Type
No Intervention
Arm Description
2 hours from Monday to Saturday, conventional physiotherapy: strengthening, stretching, dual task training.
Intervention Type
Other
Intervention Name(s)
Rhythmic auditory stimulation
Intervention Description
Rhythmic auditory stimulation 3 times in a week, and 2 hours of physiotherapy 6 days in a week.
Primary Outcome Measure Information:
Title
Balance
Description
Change in balance using the Mini Best Test
Time Frame
At baseline, 20 days after baseline and 40 days after baseline
Title
Balance
Description
Change in balance using the Tinetti Test
Time Frame
At baseline, 20 days and 40 days after baseline
Title
Gait
Description
Change in gait using the Tinetti Test
Time Frame
At baseline, 20 days after baseline and 40 days after baseline
Title
Gait
Description
Change in gait using the Timed Up&Go Test
Time Frame
At baseline, 20 days and 40 days after baseline
Title
Gait parameters
Description
Change in step length using a measure tape
Time Frame
At baseline, 20 days after baseline and 40 days after baseline
Title
Gait parameters
Description
Change in stride length using a measure tape
Time Frame
At baseline, 20 days and 40 days after baseline
Title
Gait parameters
Description
Change in cadence using a stopwatch
Time Frame
At baseline, 20 days after baseline and 40 days after baseline
Title
Gait Functionality
Description
Change in gait functionality using the Functional Ambulatory Category
Time Frame
At baseline and 40 days after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samira Gonzalez
Organizational Affiliation
Hospital Sociosanitari Mutuam Girona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Sociosanitari Mutuam Girona
City
Girona
ZIP/Postal Code
17007
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
33669715
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.
Results Reference
derived

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Effect of RAS on Balance and Gait After Stroke

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