NCT03974490

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 5, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

10 months

First QC Date

April 11, 2019

Last Update Submit

April 22, 2020

Conditions

StrokeGait, HemiplegicGait Disorders, Neurologic

Keywords

rhythmmusicotherapybalancegaitstrokephysiotherapy

Outcome Measures

Primary Outcomes (8)

  • Balance

    Change in balance using the Mini Best Test

    At baseline, 20 days after baseline and 40 days after baseline

  • Balance

    Change in balance using the Tinetti Test

    At baseline, 20 days and 40 days after baseline

  • Gait

    Change in gait using the Tinetti Test

    At baseline, 20 days after baseline and 40 days after baseline

  • Gait

    Change in gait using the Timed Up\&Go Test

    At baseline, 20 days and 40 days after baseline

  • Gait parameters

    Change in step length using a measure tape

    At baseline, 20 days after baseline and 40 days after baseline

  • Gait parameters

    Change in stride length using a measure tape

    At baseline, 20 days and 40 days after baseline

  • Gait parameters

    Change in cadence using a stopwatch

    At baseline, 20 days after baseline and 40 days after baseline

  • Gait Functionality

    Change in gait functionality using the Functional Ambulatory Category

    At baseline and 40 days after baseline

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Other: Rhythmic auditory stimulation

Historical control group

NO INTERVENTION

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

Interventions

Rhythmic auditory stimulationOTHER

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

Intervention Group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Had a stroke in the last 3 weeks
  • Rankin 3-4
  • Barthel before stroke: \>85
  • Tinetti \< 23

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Sociosanitari Mutuam Girona

Girona, 17007, Spain

Location

Related Publications (1)

  • 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.

    PMID: 33669715DERIVED

MeSH Terms

Conditions

StrokeGait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Samira Gonzalez

    Hospital Sociosanitari Mutuam Girona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Physiotherapist

Study Record Dates

First Submitted

April 11, 2019

First Posted

June 5, 2019

Study Start

April 1, 2019

Primary Completion

January 31, 2020

Study Completion

January 31, 2020

Last Updated

April 24, 2020

Record last verified: 2020-04

Locations

ES(1)