免费获得国外相关药品，最快 1 个工作日回馈药物信息
Effect of RAS on Balance and Gait After Stroke
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Stroke Gait, Hemiplegic Gait Disorders, Neurologic | Other: Rhythmic auditory stimulation | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 55 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Effect of Rhythmic Auditory Stimulation on Balance and Gait Parameters in Stroke Patients |
| Actual Study Start Date : | April 1, 2019 |
| Actual Primary Completion Date : | January 31, 2020 |
| Actual Study Completion Date : | January 31, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Intervention Group
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
Rhythmic auditory stimulation 3 times in a week, and 2 hours of physiotherapy 6 days in a week.
|
|
No Intervention: Historical control group
2 hours from Monday to Saturday, conventional physiotherapy: strengthening, stretching, dual task training.
|
- 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
| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
| Spain | |
| Hospital Sociosanitari Mutuam Girona | |
| Girona, Spain, 17007 | |
| Principal Investigator: | Samira Gonzalez | Hospital Sociosanitari Mutuam Girona |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 11, 2019 | ||||
| First Posted Date ICMJE | June 5, 2019 | ||||
| Last Update Posted Date | April 24, 2020 | ||||
| Actual Study Start Date ICMJE | April 1, 2019 | ||||
| Actual Primary Completion Date | January 31, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
|
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of RAS on Balance and Gait After Stroke | ||||
| Official Title ICMJE | Effect of Rhythmic Auditory Stimulation on Balance and Gait Parameters in Stroke Patients | ||||
| 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. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Other: Rhythmic auditory stimulation
Rhythmic auditory stimulation 3 times in a week, and 2 hours of physiotherapy 6 days in a week.
|
||||
| Study Arms ICMJE |
|
||||
| Publications * | Gonzalez-Hoelling S, Bertran-Noguer C, Reig-Garcia G, Suñer-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). pii: 2032. doi: 10.3390/ijerph18042032. | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
55 | ||||
| Original Estimated Enrollment ICMJE |
74 | ||||
| Actual Study Completion Date ICMJE | January 31, 2020 | ||||
| Actual Primary Completion Date | January 31, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender ICMJE |
|
||||
| Ages ICMJE | 18 Years to 90 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Spain | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03974490 | ||||
| Other Study ID Numbers ICMJE | Mutuam_Girona_04_19 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Samira Gonzalez Hoelling, Hospital Sociosanitari Mutuam Girona | ||||
| Study Sponsor ICMJE | Hospital Sociosanitari Mutuam Girona | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| PRS Account | Hospital Sociosanitari Mutuam Girona | ||||
| Verification Date | April 2020 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||
