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Trial details
Trial details
The Effect of Rhythmic Auditory Stimulation on Gait in Chronic Stroke Patients
Current status:
Approved
|
Date registered:
14/02/2021
|
Date last updated:
14/02/2021
Trial version(s)
Current: 07/02/2021
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Main Information
Primary registry identifying number
LBCTR2021024744
Protocol number
CEUA 056
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
20/01/2021
Primary sponsor
Farah Ayoubi
Primary sponsor: Country of origin
Lebanon
Public title
The Effect of Rhythmic Auditory Stimulation on Gait in Chronic Stroke Patients
Acronym
Scientific title
The Effect of Rhythmic Auditory Stimulation Tempo Shifts Application on Gait Parameters in Chronic Stroke Patients: A Pilot Study
Acronym
Brief summary of the study: English
To examine the effect of rhythmic auditory stimulation tempo shifts on gait in stroke patients. Ten to twenty chronic stroke patients with an onset of six months and above will be recruited based on the proposed criteria and after a thorough assessment and obtaining their consent. Participants will be instructed to walk under a self selected tempo based on their average walking cadence followed by three randomly applied conditions (-10%, +10%, and +20%) calculated based on the self-selected tempo, then finally each participant will walk without stimulation to monitor immediate effect. Kinovea (motion analysis software) and 10 meter walk test will be used to evaluate gait parameters at session 1 and session 12 respectively through all applied walking conditions to monitor short term effect.
Brief summary of the study: Arabic
لفحص تأثير التحفيز الايقاعي على المشي لدى مرضى السكتة الدماغية. سيتم توظيف عشرة إلى عشرين مريضا بالسكتة المزمنة (ستة أشهر وما فوق). بناء على المعايير المقترحة وبعد تقييم دقيق والحصول على موافقة المرضى سيتم توجيه المشاركين للسير وفقا للايقاع المحدد ذاتيا متبوعا بثلاثة شروط وظيفية عشوائية ٪١٠-, ٪١٠+ , ٪٢٠+ محددة استنادا إلى متوسط معدل سرعة المشي. ثم أخيرا سيمشي كل مشارك دون تحفيز لمراقبة تأثير العلاج الفوري. سيستخدم إختبار المشي على مسافة ١٠ أمتار و برنامج Kinovea لرصد اثر العلاج على معلمات المشي في الجلسة رقم ١ و الجلسة رقم ١٢ على التوالي.
Health conditions/problem studied: Specify
Health Condition: Chronic Stroke Patients (Hemiplegia) Problems Studied: Gait (spatio-temporal parameters)/ Walking Issues/ Motor Issues/ Impairment/ Function
Interventions: Specify
Each participant will walk along a wide unobstructed 10-m walkway at preferred speed with the possibility to use a uniform walking aid when needed, based on this each participant’s cadence will be calculated using a pedometer and then averaged over 3 trials to obtain the mean cadence. The acceleration and deceleration periods will be neglected, and this step is to be repeated each session. The self selected tempo will be set each session according to the mean cadence (number of steps/min= number of beats/min). Each participant will then walked under three randomly applied conditions which will be administered based on block randomization (-10%, +10%, and +20%) calculated from self-selected tempo (0%). Each participant will walk 3 times under baseline tempo (0%), followed by 3 times under each condition. Finally, each participant will be asked to walk for a distance of 10m without any stimulation to monitor short term effects. The obtained data will be analyzed using Kinovea software and 10-m walk test. Conventional approach (ethical considerations): The conventional treatment will consist of customized functional tasks targeting transfers such as; weight shifting while in sitting and standing, transfers from sitting to standing, and from one chair to another (with and without arm support) as well as enhancing static balance; while sitting and standing in addition to management of the upper extremity; through stretching, range of motion exercises of high repetition, and functional reaching exercises.
Key inclusion and exclusion criteria: Inclusion criteria
The inclusion criteria were as follows: 1) able to walk for a 10-m distance. 2) Able to follow instructions. 3) Doesn’t suffer from cognitive impairment with a Modified Mini Mental State Examination (3MS) score of 79 or higher. 4) Brunnstrom recovery scale of stages (4-6).
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
35
Key inclusion and exclusion criteria: Age maximum
65
Key inclusion and exclusion criteria: Exclusion criteria
Individuals were excluded if any demonstrated one or more of the following conditions: 1) Auditory or visual problems. 2) Chronic pain and/or an orthopedic condition which affects gait. 3) Symptomatic cardiac failure. 4) Neurologic condition other than initial stroke. 5) Major depression or psychological issues.
Type of Study
Type
Interventional
Type of intervention
Rehabilitation strategies
Trial scope
Therapy
Trial scope: Specify scope
Study design: Allocation
Single Arm Study
Study design: Masking
Blinded (masking used)
Study design: Control
Active
Study phase
N/A
Study design: Purpose
Treatment
Study design: Assignment
Single
Pharmaceutical class
N/A
Therapeutic indication
Such approaches are essential and crucial for stroke individuals which are hemiplegic or have a functional impairment in their lower extremities or have a motor control issues in addition to hemiparesis. Additionally such an approach is very beneficial for other neurologic populations as a primary treatment method.
Therapeutic benefit
- Optimizing Gait and Gait parameters (deviations, symmetry, cadence, velocity, step length,etc...) - Improving Balance (Static+Dynamic) - Decreasing postural issues and optimizing postural control - Motor Relearning - Inducing and Optimizing Brain plasticity - Optimizing quality of life - Optimizing independence - Optimizing functional capacities - Decreasing morbidity rates - Decreasing mortality rates - Prevention of recurrence of health issues - Improving Mental state and cognition
Biospecimen retention
None retained
Biospecimen description
N/A
Target sample size
30
Actual enrollment target size
10
Date of first enrollment: Type
Actual
Date of first enrollment: Date
04/01/2021
Date of study closure: Type
Actual
Date of study closure: Date
04/03/2021
Recruitment status
Recruiting
Date of completion
14/02/2021
IPD sharing statement plan
No
IPD sharing statement description
At this current point we would prefer to keep our data disclosed, as soon as we are done with the study as eligible we will be submitting the trial to a journal for a prospect publication.
Additional data URL
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Ethics Committee at the Antonine University (CEUA)
CEUA 056
Sources of Monetary or Material Support
Name
Secondary Sponsors
Name
NA
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Farah
AYOUBI
Tripoli
Lebanon
71765367
farah.ayoubi@ua .edu.lb
Research Advisor/ Supervisor / Research Instructor/ MPT/ PhD/ PT at Antonine University
Scientific
Marie Catherine
Baradhii
Baabda
Lebanon
70686738
mariecatherine2@hot mail.com
Researche r/ Research Supervisor / Clinical Instructor/ DPT/ MPT/ PT
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Arc en ciel (Jesr l Wate)
Dr. Jeanine Matar (yet, researcher conducted trial)
DPT
Approved
Mousawat Foundation
N/A (researcher conducted trial)
PT
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Other
Ethics committe of the Antonine University (CEUA)
26/11/2020
Nidaa Abou Mrad
nidaa.aboumrad@ua.edu.lb
05927000
Countries of Recruitment
Name
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
Stroke/ Hemiplegia
Hemiplegia (G81)
stroke/ hemi/ gait/ function/ RAS
Interventions
Intervention
Description
Keyword
Gait Re-education under Rhythmic Auditory Stimulation
Rhythmic Auditory Stimulation is a neurologic technique used to facilitate the rehabilitation of movements that are intrinsically biologically rhythmical, most importantly gait. RAS uses the physiological effects of auditory rhythm on the motor system to improve the control of movement in rehabilitation of functional, stable, and adaptive gait patterns in patients with significant gait deficits due to neurologic impairment.
RAS
Primary Outcomes
Name
Time points
Measure
Angle measurements
At session 1 and session 12
Angles in degrees via Kinovea software
Angle symmetry
At session 1 and session 12
SI (symmetry index)
Velocity
At session 1 and session 12
10m walk test
Cadence
At session 1 and session 12
Number of steps/min using pedometer
Step Length
At session 1 and session 12
Steps in cm using kinovea software
Key Secondary Outcomes
Name
Time points
Measure
Cognition (pre-requisite to enrollment)
At session 1 (pre-experiment)
3MS (Modified Mini Mental State examination)
Muscular strength/ Motor ability (global)
At session 1 (pre-experiment)
Brunnstrom scale
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Download as PDF
Save a PDF copy of the summary of the trial