StrokeNCT03974490
Effect of RAS on Balance and Gait After Stroke
A study testing Rhythmic auditory stimulation in people with Stroke and Gait, Hemiplegic, run by Hospital Sociosanitari Mutuam Girona at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke, Gait, Hemiplegic, Gait Disorders, Neurologic
- What is being tested?
- Rhythmic auditory stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2019to 31 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Had a stroke in the last 3 weeks
- Rankin 3-4
- Barthel before stroke: >85
- Tinetti < 23
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Rhythmic Auditory Stimulation on Balance and Gait Parameters in Stroke Patients
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.
Read the 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.
- Conditions
- Stroke, Gait, Hemiplegic, Gait Disorders, Neurologic
- Being tested
- Rhythmic auditory stimulation
- Keywords
- rhythm, musicotherapy, balance, gait, stroke, physiotherapy
- Medical subject headings
- Stroke, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhythmic auditory stimulationOther
Rhythmic auditory stimulation 3 times in a week, and 2 hours of physiotherapy 6 days in a week.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Rhythmic auditory stimulation |
| Historical control group | No intervention | 2 hours from Monday to Saturday, conventional physiotherapy: strengthening, stretching, dual task training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
Change in balance using the Mini Best Test
Measured: At baseline, 20 days after baseline and 40 days after baseline
Balance
Change in balance using the Tinetti Test
Measured: At baseline, 20 days and 40 days after baseline
Gait
Change in gait using the Tinetti Test
Measured: At baseline, 20 days after baseline and 40 days after baseline
Gait
Change in gait using the Timed Up\&Go Test
Measured: At baseline, 20 days and 40 days after baseline
Gait parameters
Change in step length using a measure tape
Measured: At baseline, 20 days after baseline and 40 days after baseline
Gait parameters
Change in stride length using a measure tape
Measured: At baseline, 20 days and 40 days after baseline
Gait parameters
Change in cadence using a stopwatch
Measured: At baseline, 20 days after baseline and 40 days after baseline
Gait Functionality
Change in gait functionality using the Functional Ambulatory Category
Measured: At baseline and 40 days after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start1 Apr 2019
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Sociosanitari Mutuam Girona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samira Gonzalez Hoelling, Hospital Sociosanitari Mutuam Girona
- Investigators
- Samira Gonzalez, Principal investigator, Hospital Sociosanitari Mutuam Girona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974490
- Sponsor's protocol ID
- Mutuam_Girona_04_19
- Status last verified
- Apr 2020
- First submitted
- 11 Apr 2019
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33669715
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rhythmic Auditory Stimulation on Balance and Gait Parameters in Stroke Patients
- ClinicalTrials.gov ID
- NCT03974490
- Acronym / sponsor ID
- Mutuam_Girona_04_19
- Conditions
- Stroke, Gait, Hemiplegic, Gait Disorders, Neurologic
- Keywords
- rhythm, musicotherapy, balance, gait, stroke, physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Hospital Sociosanitari Mutuam GironaUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 5 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Rhythmic auditory stimulation2 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. |
| Historical control group | No intervention | –2 hours from Monday to Saturday, conventional physiotherapy: strengthening, stretching, dual task training. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Had a stroke in the last 3 weeks
- Rankin 3-4
- Barthel before stroke: >85
- Tinetti < 23
Key exclusion criteria (6 listed)
- Patient can walk independently (Functional Ambulation Category >3)
- Global and/or mixed aphasia
- Glasgow < 10
- Mini-Mental State Examination < 24
- Posterior cerebral artery stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rhythmic auditory stimulationRhythmic auditory stimulation 3 times in a week, and 2 hours of physiotherapy 6 days in a week. | Other | Intervention Group |
Primary outcome
Balance
Time frame: At baseline, 20 days after baseline and 40 days after baseline
Change in balance using the Mini Best Test
Balance
Time frame: At baseline, 20 days and 40 days after baseline
Change in balance using the Tinetti Test
Gait
Time frame: At baseline, 20 days after baseline and 40 days after baseline
Change in gait using the Tinetti Test
Gait
Time frame: At baseline, 20 days and 40 days after baseline
Change in gait using the Timed Up\&Go Test
Gait parameters
Time frame: At baseline, 20 days after baseline and 40 days after baseline
Change in step length using a measure tape
Gait parameters
Time frame: At baseline, 20 days and 40 days after baseline
Change in stride length using a measure tape
Gait parameters
Time frame: At baseline, 20 days after baseline and 40 days after baseline
Change in cadence using a stopwatch
Gait Functionality
Time frame: At baseline and 40 days after baseline
Change in gait functionality using the Functional Ambulatory Category
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Derived from this study: PubMed 33669715Gonzalez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samira Gonzalez principal investigator
Hospital Sociosanitari Mutuam Girona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhythmic auditory stimulation in people with Stroke and Gait, Hemiplegic, run by Hospital Sociosanitari Mutuam Girona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: At baseline, 20 days after baseline and 40 days after baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03974490, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.