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StrokeNCT07428824

Effects Of Functional Action Observation With Auditory Cueing In Stroke Patients

A study testing Functional Action Observation Therapy and Functional Action Observation Therapy with rhythmic auditory stimulation group in people with Stroke, run by Riphah International University at 2 sites in Pakistan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 40 to 60 years
Conditions the study is for
Stroke
What is being tested?
Functional Action Observation Therapy and Functional Action Observation Therapy with rhythmic auditory stimulation group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesPakistan
Study dates
5 Nov 2025to 30 Apr 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 40 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Shirin Kamran, MSPT-NM contact

03114759567

shirinkamran786@gmail.com

Pakistan2 sites, 2 recruiting
  • Alara Healthcare Clinic

    Lahore, Punjab Province

    Shirin, MSPT-NM, 03114759567, shirinkamram786@gmail.com

    Recruiting
  • Ittefaq Hospital Trust, Lahore

    Lahore, Punjab Province

    Shirin, MSPT-NM, 03114759567, shirinkamram786@gmail.com

    Recruiting

Other trials in Pakistan

About this study

Official title: 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

Read the 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.

Conditions
Stroke
Being tested
Functional Action Observation Therapy, Functional Action Observation Therapy with rhythmic auditory stimulation group
Keywords
Balance, Neuroplasticity, Rehabilitation, Stroke
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Functional Action Observation TherapyOther

    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

  • Functional Action Observation Therapy with rhythmic auditory stimulation groupOther

    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.

Study groups in NCT07428824
Study groupRoleWhat they receive
Eperimental Group AExperimentalFunctional Action Observation Therapy
Receives: Other: Functional Action Observation Therapy
Eperimental Group BExperimentalFunctional Action Observation Therapy with rhythmic auditory stimulation
Receives: Other: Functional Action Observation Therapy with rhythmic auditory stimulation group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Berg Balance Scale

    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

    Measured: Baseline

  2. Berg Balance Scale

    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

    Measured: 4 weeks

Secondary outcomes (2)
  1. Functional Gait Assessment

    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

    Measured: Baseline

  2. Functional Gait Assessment

    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

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2026
  2. Study start5 Nov 2025
  3. Primary completion12 Apr 2026 (estimated)
  4. Study completion30 Apr 2026 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07428824
Sponsor's protocol ID
REC/0286 Shirin
Status last verified
Feb 2026
First submitted
8 Dec 2025
Last updated
24 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 35317736
  • 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.

    PubMed 30271375
  • 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.

    PubMed 38245704
  • 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.

    PubMed 37447782
  • 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.

    PubMed 37877724

Questions about this trial

What is this clinical trial studying?

A study testing Functional Action Observation Therapy and Functional Action Observation Therapy with rhythmic auditory stimulation group in people with Stroke, run by Riphah International University at 2 sites in Pakistan.

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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Pakistan. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shirin Kamran, MSPT-NM (03114759567, shirinkamran786@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Berg Balance Scale (time frame: Baseline). The study lists 2 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 NCT07428824, which also lists 5 linked publications.

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 Feb 2026.

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