StrokeNCT06059742
Action Observation Therapy With and Without Acoustic Stimulation in Post Stroke Gait and Balance
A study testing Action Observation Therapy with Rhythmic acoustic stimulation and Action Observation Therapy without Rhythmic acoustic stimulation in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
Stroke causes the interruption of blood flow towards the brain cells which results in cell death and lead to variety of disorders including deficits in balance and gait. It is well known that it is causing death and disability .The incidence of stroke is increasing in low-income countries because of not using… Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Stroke
- What is being tested?
- Action Observation Therapy with Rhythmic acoustic stimulation and Action Observation Therapy without Rhythmic acoustic stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2023to 30 Jan 2024
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 40-60 years
- Both male and female
- Any type of stroke
- Walking few steps [5 or more] .
- Berg balance score above 21
- Ability to follow the study instructions-Mini mental state examination (MMSE ) score >24
Who cannot join
- Patients diagnosed with other neurological diseases
- Tumors or neoplasms
- Cardiopulmonary diseases
- Patient with impaired cognition
- Visual and auditory impairments
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
HBS hospital Lehtrar Road Alipur
Islamabad, 45600
Tania Saeed, MS NMPT*
About this study
Official title: The Effects of Action Observation Therapy With and Without Acoustic Stimulation on Balance and Gait Among Stroke Survivors
Stroke causes the interruption of blood flow towards the brain cells which results in cell death and lead to variety of disorders including deficits in balance and gait. It is well known that it is causing death and disability .The incidence of stroke is increasing in low-income countries because of not using evidence-based practice in health-related conditions in these countries. Action observation training is one of the new developing rehabilitation technique that targets motor learning by the activation of mirror neurons and is the most important approach that targets the motor and functional recovery in stroke patients. A new treatment approach i .e action observation therapy, in which the movements are observed by the patient to provide visual stimulus, then patients are asked to perform those movements. A new approach acoustic stimulation is introduced for improving gait and balance in post stroke patients in which individual patient cadence is used to adjust the beats of sound so that auditory stimulation causes recovery.
Read the detailed description
Stroke is a medical condition which causes the cessation of blood flow to the brain cells and results in cell death. It is a leading cause of death and disability. Geographical variations play a huge role in the burden for stroke. A stroke survivor experiences a range of symptoms that make it harder for them to carry out regular tasks and raise their risk of falling while walking .The effects of Action Observation Therapy with acoustic stimulation on balance in stroke patients have not been explicitly covered in recent studies. The study intends to evaluate the effectiveness of treatments with evidence for post-stroke balance and gait.
- Conditions
- Stroke
- Being tested
- Action Observation Therapy with Rhythmic acoustic stimulation, Action Observation Therapy without Rhythmic acoustic stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action Observation Therapy with Rhythmic acoustic stimulationOther
Action observation therapy is observing some action and the performing Rhythmic acoustic stimulation is performing movement on the rhythm of beats
Action Observation Therapy without Rhythmic acoustic stimulationOther
Action observation therapy is observing some action and the performing Rhythmic acoustic stimulation is performing movement on the rhythm of beats
| Study group | Role | What they receive |
|---|---|---|
| Action Observation Therapy with Acoustic Stimulation | Experimental | The patients in the action observation therapy with acoustic stimulation group will be required to observe the lower limb movements or functional actions with sound of beats in video clips. (i.e., the observation phase) and to execute what they had observed to the best of their ability with sound of beats given through headphones (i.e., the execution phase). Three common categories of movements will be elected in the protocol for each week based on the related literature Receives: Other: Action Observation Therapy with Rhythmic acoustic stimulation |
| Action Observation Therapy Without Acoustic Stimulation | Active comparator | The patients in the action observation therapy without acoustic stimulation group will be required to observe the lower limb movements or functional actions without sound of beats in video clips. (i.e., the observation phase) and to execute what they had observed to the best of their ability without sound of beats (i.e., the execution phase). Three common categories of movements will be elected in the protocol for each week based on the related literature Receives: Other: Action Observation Therapy without Rhythmic acoustic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
It is often used to assess balance and mobility as well as identify people who are at risk of falling. 14 different balance-related tasks, including sitting, standing, and transferring, are included in the tool. Each factor is scored from 0 to 4, with 0 suggesting significant impairment and 4 denoting the patient's balance system operating normally
Measured: week 8
Wisconsin Gait Scale
Wisconsin Gait Scale is an observational tool for the evaluation of gait quality in individuals after stroke with hemiplegia. It is divided into four sub scales, which assess a total of fourteen spatiotemporal and kinematic parameters of gait observed during the consecutive gait phases.
Measured: week 8
Time Up and Go Test
The Timed Up and Go test, which integrates elements of gait and balance control, has primarily been used to predict the risk of falling in geriatric populations. Patients are instructed to stand up from a chair, move 3 meters at a safe and comfortable speed, turn around, and then return to the chair and sit down.
Measured: week 8
6 Min Walk Test
it is a simple and effective test that requires the subject to walk as fast as they can for six minutes. Because of this, it relies on patient-determined, individually modified parameters, and patients are even permitted to quit walking if they so desire
Measured: week 8
Secondary outcomes (1)
Functional Reach Test
A static balance test called the functional reach test is frequently used to evaluate a subject's level of balance when they are standing.The reach distance during this has been used as a measurement for determining fall risk
Measured: week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Sep 2023
- Primary completion30 Jan 2024 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayesha Afridi, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059742
- Sponsor's protocol ID
- Riphah/RCRAHS-ISB/REC/01642
- Status last verified
- Sep 2023
- First submitted
- 22 Sep 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Action Observation Therapy With and Without Acoustic Stimulation on Balance and Gait Among Stroke Survivors
- ClinicalTrials.gov ID
- NCT06059742
- Acronym / sponsor ID
- Riphah/RCRAHS-ISB/REC/01642
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Jan 2024 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 29 Sep 2023 (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.
Stroke causes the interruption of blood flow towards the brain cells which results in cell death and lead to variety of disorders including deficits in balance and gait. It is well known that it is causing death and disability .The incidence of stroke is increasing in low-income countries because of not using evidence-based practice in health-related conditions in these countries. Action observation training is one of the new developing rehabilitation technique that targets motor learning by the activation of mirror neurons and is the most important approach that targets the motor and functional recovery in stroke patients. A new treatment approach i .e action observation therapy, in which the movements are observed by the patient to provide visual stimulus, then patients are asked to perform those movements. A new approach acoustic stimulation is introduced for improving gait and balance in post stroke patients in which individual patient cadence is used to adjust the beats of sound so that auditory stimulation causes recovery.
Detailed description
Stroke is a medical condition which causes the cessation of blood flow to the brain cells and results in cell death. It is a leading cause of death and disability. Geographical variations play a huge role in the burden for stroke. A stroke survivor experiences a range of symptoms that make it harder for them to carry out regular tasks and raise their risk of falling while walking .The effects of Action Observation Therapy with acoustic stimulation on balance in stroke patients have not been explicitly covered in recent studies. The study intends to evaluate the effectiveness of treatments with evidence for post-stroke balance and gait.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Action Observation Therapy with Acoustic Stimulation | Experimental | Other: Action Observation Therapy with Rhythmic acoustic stimulationThe patients in the action observation therapy with acoustic stimulation group will be required to observe the lower limb movements or functional actions with sound of beats in video clips. (i.e., the observation phase) and to execute what they had observed to the best of their ability with sound of beats given through headphones (i.e., the execution phase). Three common categories of movements will be elected in the protocol for each week based on the related literature |
| Action Observation Therapy Without Acoustic Stimulation | Active comparator | Other: Action Observation Therapy without Rhythmic acoustic stimulationThe patients in the action observation therapy without acoustic stimulation group will be required to observe the lower limb movements or functional actions without sound of beats in video clips. (i.e., the observation phase) and to execute what they had observed to the best of their ability without sound of beats (i.e., the execution phase). Three common categories of movements will be elected in the protocol for each week based on the related literature |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 40-60 years
- Both male and female
- Any type of stroke
- Walking few steps [5 or more] .
- Berg balance score above 21
Key exclusion criteria (5 listed)
- Patients diagnosed with other neurological diseases
- Tumors or neoplasms
- Cardiopulmonary diseases
- Patient with impaired cognition
- Visual and auditory impairments
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 |
|---|---|---|
| Action Observation Therapy with Rhythmic acoustic stimulationAction observation therapy is observing some action and the performing Rhythmic acoustic stimulation is performing movement on the rhythm of beats | Other | Action Observation Therapy with Acoustic Stimulation |
| Action Observation Therapy without Rhythmic acoustic stimulationAction observation therapy is observing some action and the performing Rhythmic acoustic stimulation is performing movement on the rhythm of beats | Other | Action Observation Therapy Without Acoustic Stimulation |
Primary outcome
Berg Balance Scale
Time frame: week 8
It is often used to assess balance and mobility as well as identify people who are at risk of falling. 14 different balance-related tasks, including sitting, standing, and transferring, are included in the tool. Each factor is scored from 0 to 4, with 0 suggesting significant impairment and 4 denoting the patient's balance system operating normally
Wisconsin Gait Scale
Time frame: week 8
Wisconsin Gait Scale is an observational tool for the evaluation of gait quality in individuals after stroke with hemiplegia. It is divided into four sub scales, which assess a total of fourteen spatiotemporal and kinematic parameters of gait observed during the consecutive gait phases.
Time Up and Go Test
Time frame: week 8
The Timed Up and Go test, which integrates elements of gait and balance control, has primarily been used to predict the risk of falling in geriatric populations. Patients are instructed to stand up from a chair, move 3 meters at a safe and comfortable speed, turn around, and then return to the chair and sit down.
6 Min Walk Test
Time frame: week 8
it is a simple and effective test that requires the subject to walk as fast as they can for six minutes. Because of this, it relies on patient-determined, individually modified parameters, and patients are even permitted to quit walking if they so desire
1 secondary outcome
Functional Reach Test
Time frame: week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Ayesha Afridi, PhD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action Observation Therapy with Rhythmic acoustic stimulation and Action Observation Therapy without Rhythmic acoustic stimulation in people with Stroke, run by Riphah International University at 1 site 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: status not confirmed, as of the sponsor's last update on 29 Sep 2023. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tania Saeed, MS NMPT* (0315 6996746, taniasaeed1995@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: week 8). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2023.