- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07428824
Effects Of Functional Action Observation With Auditory Cueing In Stroke Patients
Effects of Functional Action Observation Therapy With Rhythmic Auditory Cueing on Balance and Gait in Patients With Stroke
This study aims to determine the effects of functional action observation therapy with and without rhythmic auditory cueing on balance and gait in patients with stroke.
A randomized clinical trial will be conducted at Ittefaq Hospital Trust, Lahore and Alara Healthcare Clinic. The sample size will be 40. The non-probability convenience sampling methodology will be used to select participants who match the inclusion criteria and the online randomization will be used to further randomize them.Participants will be divided into 2 groups, 20 patients in clinical group and 20 patients in experimental group. While the clinical group will receive traditional therapy, the experimental group will receive Funtional Action Observation Therapy with auditory cueing. For four weeks, the subjects underwent 30 minutes of FAO or general action observation (GAO) instruction five times a week. The outcome measures will include assessments of balance and gait using Berg Balance Scale and Functional Gait Assessment. Assessments will be conducted on patients both before and after the intervention to identify any notable variations in their gait and balance
Study Overview
Status
Conditions
Detailed Description
Stroke is acute, focal neurological impairment caused by vascular injury (infarction, hemorrhage) of the central nervous system. In the 1970s, the World Health Organization defined a stroke as a sudden neurological deficit resulting from cerebrovascular dysfunction that lasts more than twenty-four hours or terminated by death within twenty-four hours. The two primary types of stroke are 90% ischemic stroke and 10% haemorrhagic stroke. The three main causes of stroke are high blood pressure, small heart disease, and diabetes. Patients with high blood pressure (above 160/95 mm Hg) have a 4-6 times higher risk of stroke, and cardiovascular risk is increased by high total blood cholesterol and low-density lipoprotein cardiac diseases like rheumatic heart vascular disease, endocarditis, and heart surgery. According to disability-adjusted life-years, stroke was the third most common cause of death and disability worldwide and the second most common cause of death overall. Over 60% of stroke survivors suffer from motor impairments that significantly lower their quality of life . Previous study reveals that the prevalence of stroke in Pakistan is 4.8%, with a comparable ratio for men and women. Additionally, 30% of all strokes were reported to have happened in people under the age of 45, indicating a high burden of strokes in Pakistan among young people .
Mirror neurons are brain neurons that fire when a person performs an action and when they witness someone else perform the same action. Action observation treatment aims to activate these mirror neurons in stroke patients' brains to facilitate functional reorganization and the recovery of motor function. AOT promotes the restructuring of cortical alterations and the restoration of cognitive references by focusing attention on the primary mechanisms influencing movement quality and facilitating motor system engagement. Therefore, motor learning and the development or restoration of a motor memory through the MNS can result from AOT. Action observation (AO), which involves motor brain regions comparable to those that typically fire during movement, can be understood as a type of "motor simulation" that evokes an internal representation of the witnessed movement, also known as "motor resonance." AO can help with movement performance in addition to sharing a brain pattern with motor execution. AOT is thought to be especially helpful for reactivating the motor system in situations when severe motor function impairment or the presence of pain, inflammation, or muscle exhaustion make intense motor training impractical. The same set of motor neurons that produce the observed action in the observer can be directly and subliminally activated by AO. Action observation's ability to excite the motor system via the network of mirror neurons offers a way to encourage neuroplasticity and restore motor function following stroke hemiparesis that would not be possible with use-dependent therapies alone. Cortical remapping, substitution (in which healthy tissues take over the tasks of injured areas), reorganization within damaged areas, and the formation of new receptive fields have all been implicated in the recovery of function after a stroke, which is purportedly facilitated by the mirror neuron system. Action observation training increases the primary motor cortex's excitability, and the combination of action observation and physical training significantly fosters the growth of motor memory. Regular balance training can be enhanced by neurorehabilitation, which involves directly stimulating the brain to produce structural and functional changes. Neurologic music treatment uses a technique called rhythmic auditory stimulation, which is based on repetitive and rhythmic auditory stimuli. It facilitates internally generated rhythmic actions, like walking, by using an external rhythm (music). Furthermore, from a neurophysiological perspective, RAS may help post-stroke patients with internal neuronal timing and can be utilized as auditory signals for walking. RAS has a major impact on enhancing symmetry, gait coordination, and balance. The regulation of corticostriatal activity and auditory-motor connection is thought to be the cause of RAS's action. Since asymmetry is quickly improved when foot contact timing is synchronized with a metronome tempo while walking, RAC suggests that temporal symmetry could be controlled as a conditional setting. The neuronal activity of the auditory and premotor cortex during rhythm processing has been discovered to be closely related, confirming that interactions between the auditory and motor systems underlie rhythm perception. An intervention employing rhythmic auditory stimulation can benefit individuals in both the acute and chronic stages after a stroke by increasing gait speed, improving static balance, and lengthening the affected side's steps and cadence. The concepts of auditory-motor entrainment are applied in a particular way when rhythmic music is used to improve movement speed and consistency. The availability of auditory cues, which are increased sensory information, may help the learner concentrate on the most important information to enhance their motor performance. The therapeutic effects of RAS include reducing variability through rhythmic cues and regulating spatiotemporal and force parameters while specifying a movement's dynamics. Consequently, using frequent exercise to achieve the ideal movement pattern. In addition to facilitating movement anticipation and preparation and maybe avoiding injured areas by activating alternate pathways, rhythmic auditory cues may aid in motor priming. Acoustic cues that synchronize motor response through rhythmic cueing are what define RAS. Neuronal substrates that affect movements create the synchronous link. Consequently, an internal timing process is used to synchronize the subject's motions with outside auditory stimuli. Balance control and gait performance are not rhythmic. However, by enhancing focus and task priority, the addition of rhythmic auditory cueing may increase the benefits of balance training. Sound can raise the excitability of motor neurons in the reticulo-spinal tract's auditory-motor circuitry, decreasing the time it takes for a muscle to initiate a motor command by supporting anticipatory motor control patterns in the brain stem and spinal cord. According to research on brain imaging, the auditory-motor network is altered by music and rhythm perception, which makes movements easier. Rhythmic auditory cueing's cyclic nature seems to efficiently regulate musculoskeletal activation pattern variability, leading to more effective motor unit recruitment, joint movement facilitation, and movement time grading. RAS improves a patient's performance by making them more focused during an exercise session. Users are usually told to time their steps to the beat of the music or metronome while RAS. Improvements in gait are thought to be based on synchronizing and, as a result, entraining movement with the stimuli.
The significance of the study is the need for effective therapies to enhance the gait and balance of stroke victims, since these areas often decline following a stroke, decreasing their independence and increasing their risk of falling. Functional Action Observation Therapy (FAOT), which involves having patients observe specific behaviours, stimulates the brain's mirror neuron system, which may aid in rehabilitation by activating neuronal pathways linked to motor control. Adding auditory cueing into FAOT may enhance motor rehabilitation since timing and rhythm are known to be enhanced by auditory cues, which are necessary for balanced and coordinated motions. In order to help develop more effective stroke rehabilitation procedures, this study attempts to determine whether FAOT and auditory cueing combination have a greater influence on balance and gait than traditional rehabilitation techniques.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shirin Kamran, MSPT-NM
- Phone Number: 03114759567
- Email: shirinkamran786@gmail.com
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan
- Recruiting
- Alara healthcare clinic
-
Contact:
- Shirin, MSPT-NM
- Phone Number: 03114759567
- Email: shirinkamram786@gmail.com
-
Lahore, Punjab Province, Pakistan
- Recruiting
- Ittefaq Hospital Trust, Lahore
-
Contact:
- Shirin, MSPT-NM
- Phone Number: 03114759567
- Email: shirinkamram786@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 40 to 60 years
- Both male and female patients are included in the study
- 6 months to 2 years since the onset of stroke
- Ability to sit and stand up independently
- Ability to walk more than 10 m, with or without an assistant device
- No orthopedic impairments on both lower
Exclusion Criteria:
- Subjects with MMSE score less than 25
- a positive history of neoplasms, cardiovascular disease, respiratory disease clinically significant muscular-skeletal disease
- uncorrected visual or auditory disturbances
- hospitalization in the previous three months
- Patients with aggressive behavioral alterations or emotional lability
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Eperimental Group A
Functional Action Observation Therapy
|
Group A will receive a session of Functional Action Observation Therapy.
Treatment session will be given 30 mins starting with 5 mins warm up and ending with 5 mins cool down.
During 30 mins exercise participant will watch videos of functional activities for 15 min and then perform those activities for 15 mins with 30 secs rest after every activity
|
|
Experimental: Eperimental Group B
Functional Action Observation Therapy with rhythmic auditory stimulation
|
Group B will receive a session of Functional Action Observation Therapy with rhythmic auditory cueing.
Treatment session will be given 30 mins starting with 5 mins warm up and ending with 5 mins cool down.
During 30 mins exercise participant will watch videos of functional activities with rhythmic auditory cueing for 15 min and then perform those activities for 15 mins with 30 secs rest after every activity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Berg Balance Scale
Time Frame: Baseline
|
The 14 items in the BBS include both static and dynamic tasks with different levels of complexity.
The highest test score is 56, and each item is given a score between 0 and 4. Higher scores indicate greater balance ability.
The test is great for assessing falls and gait speed in chronic stroke patients, and it has excellent validity and reliability in stroke patients.
BBS's alpha coefficient is 0.79, which indicates strong internal consistency
|
Baseline
|
|
Berg Balance Scale
Time Frame: 4 weeks
|
The 14 items in the BBS include both static and dynamic tasks with different levels of complexity.
The highest test score is 56, and each item is given a score between 0 and 4. Higher scores indicate greater balance ability.
The test is great for assessing falls and gait speed in chronic stroke patients, and it has excellent validity and reliability in stroke patients.
BBS's alpha coefficient is 0.79, which indicates strong internal consistency
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Gait Assessment
Time Frame: Baseline
|
A clinical instrument called the Functional Gait Assessment (FGA) is used to assess balance and gait while doing different walking tasks.
Walking with head turns, walking while pivoting, and walking with eyes closed are among the ten activities that make up the FGA and are used to evaluate various facets of gait and balance.
A scale of 0 to 3 is used to score each task; higher scores correspond to better functional performance.
The FGA displays strong inter-rater reliability, with intraclass correlation coefficients (ICCs) reported between 0.86 and 0.93 across several investigations
|
Baseline
|
|
Functional Gait Assessment
Time Frame: 4 weeks
|
A clinical instrument called the Functional Gait Assessment (FGA) is used to assess balance and gait while doing different walking tasks.
Walking with head turns, walking while pivoting, and walking with eyes closed are among the ten activities that make up the FGA and are used to evaluate various facets of gait and balance.
A scale of 0 to 3 is used to score each task; higher scores correspond to better functional performance.
The FGA displays strong inter-rater reliability, with intraclass correlation coefficients (ICCs) reported between 0.86 and 0.93 across several investigations
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Binash Afzal, PHD, Riphah International University
Publications and helpful links
General Publications
- Errante A, Saviola D, Cantoni M, Iannuzzelli K, Ziccarelli S, Togni F, Simonini M, Malchiodi C, Bertoni D, Inzaghi MG, Bozzetti F, Menozzi R, Quarenghi A, Quarenghi P, Bosone D, Fogassi L, Salvi GP, De Tanti A. Effectiveness of action observation therapy based on virtual reality technology in the motor rehabilitation of paretic stroke patients: a randomized clinical trial. BMC Neurol. 2022 Mar 22;22(1):109. doi: 10.1186/s12883-022-02640-2.
- Mainka S, Wissel J, Voller H, Evers S. The Use of Rhythmic Auditory Stimulation to Optimize Treadmill Training for Stroke Patients: A Randomized Controlled Trial. Front Neurol. 2018 Sep 14;9:755. doi: 10.3389/fneur.2018.00755. eCollection 2018.
- Gonzalez-Hoelling S, Reig-Garcia G, Bertran-Noguer C, Suner-Soler R. The effects of rhythmic auditory stimulation on functional ambulation after stroke: a systematic review. BMC Complement Med Ther. 2024 Jan 20;24(1):45. doi: 10.1186/s12906-023-04310-3.
- Scataglini S, Van Dyck Z, Declercq V, Van Cleemput G, Struyf N, Truijen S. Effect of Music Based Therapy Rhythmic Auditory Stimulation (RAS) Using Wearable Device in Rehabilitation of Neurological Patients: A Systematic Review. Sensors (Basel). 2023 Jun 26;23(13):5933. doi: 10.3390/s23135933.
- Roelofs JMB, Zandvliet SB, Schut IM, Huisinga ACM, Schouten AC, Hendricks HT, de Kam D, Aerden LAM, Bussmann JBJ, Geurts ACH, Weerdesteyn V. Mild Stroke, Serious Problems: Limitations in Balance and Gait Capacity and the Impact on Fall Rate, and Physical Activity. Neurorehabil Neural Repair. 2023 Dec;37(11-12):786-798. doi: 10.1177/15459683231207360. Epub 2023 Oct 25.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/0286 Shirin
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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