StrokeNCT06818188
Effect of Rhythmic Auditory Stimulation(RAS) on Turning in Post-stroke Patients
A study testing Turning based specific training with rhythmic auditory stimulation (RAS) and Turning based specific training without rhythmic auditory stimulation (RAS) in people with Stroke, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
As, stroke is the second leading cause of death and disability globally, leads to postural changes, disturbance in balance, increase fall risks, \& gait dysfunctions, affecting daily activities and walking ability.As, turning is the major component of ambulation. Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Stroke
- What is being tested?
- Turning based specific training with rhythmic auditory stimulation (RAS) and Turning based specific training without rhythmic auditory stimulation (RAS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 18 Apr 2024to 30 Dec 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 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 45-60 years
- Male \& Females both
- Sub-acute \& chronic ischemic stroke patient (MCA >6months)
- Mini Mental State Examination score of 25 or higher
- Functional Ambulation Category score 2-3
- Berg Balance scale score of 40-50
Who cannot join
- Hemorrhagic stroke
- Case or history of epilepsy
- Patients, having other neurological conditions, Alzheimer, Parkinson \& Dementias
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Foundation University College of Physical Therapy
Islamabad, 44000
About this study
As, stroke is the second leading cause of death and disability globally, leads to postural changes, disturbance in balance, increase fall risks, \& gait dysfunctions, affecting daily activities and walking ability.As, turning is the major component of ambulation. But this difficulty in post stroke results in increased fall risk.Stroke survivors encounter multiple gait abnormalities, which increases difficulty in changing direction.Multiple studies have reported that, RAS with beats of metronome is an effective intervention on balance \& gait patterns i-e stride length, gait speed, \& symmetry in post-stroke patients .With little evidence available targeting comparative effectiveness with \& without RAS on turning in post-stroke patients. This study will fill this gap, to determine the effect on changing direction, with \& without RAS and will be helpful in providing evidence to literature, will provide treatment protocol for turning in gait.
Read the detailed description
CHAPTER III OBJECTIVES OF STUDY
- To determine the effect on turning in post-stroke patients with and without rhythmic auditory stimulation (RAS)
- To determine the effect on balance in post-stroke patients with and without rhythmic auditory stimulation (RAS)
- To determine the effect on cadence in post-stroke patients with and without rhythmic auditory stimulation (RAS)
- To determine the effect on gait speed in post-stroke patients with and without rhythmic auditory stimulation (RAS)
HYPOTHESIS OF STUDY
ALTERNATE HYPOTHESIS:
- HA: There is a statistically significant difference on turning in post-stroke patients with and without RAS i-e P<0.5
- HA: There is a statistically significant difference on balance in post-stroke patients with and without RAS i-e P<0.5
- HA: There is a statistically significant difference on cadence in post-stroke patients with and without RAS i-e P<0.5 4:HA: There is a statistically significant difference on gait speed in post-stroke patients with and without RAS i-e P<0.5
NULL HYPOTHESIS:
- HO: There is no statistically significant difference on turning in post-stroke patients with and without RAS i-e P>0.5
- HO: There is no statistically significant difference on balance in post-stroke patients with and without RAS i-e P>0.5
- HO: There is no statistically significant difference on cadence in post-stroke patients with and without RAS i-e P>0.5
- HO: There is no statistically significant difference on gait speed in post-stroke patients with and without RAS i-e P>0.5
Sample Selection Criteria:
Recruitment was based on the inclusion and exclusion criteria, as below:
Inclusion Criteria:
Age 45-60 years Male and Females both Sub-acute and chronic ischemic stroke patient (MCA >6months) Mini Mental State Examination score of 25 or higher Functional Ambulation Category (2-3) Berg Balance scale, score of 40-50
Exclusion Criteria:
Hemorrhagic stroke Case or history of epilepsy Patients, having other neurological conditions, Alzheimer, Parkinson \& Dementias
RANDOMIZATION \& ALLOCATION:
Recruited participants were allocated to the experimental and the control group through simple random sampling technique using coin toss method.
Experimental group has received Turning based specific training with Rhythmic Auditory Stimulation (TBST-RAS).
Control group has received Turning based specific training without Rhythmic Auditory Stimulation (TBST).
BLINDING:
This study was non-blinded.
DATA COLLECTION PROCEDURE:
Before commencing data collection, we obtained ethical approval from ERC Foundation University Islamabad, following which approval from the higher authorities of Fauji Foundation Hospital Rawalpindi was taken. Participants were approached during their free time and referred by medical OPD who were willing to volunteer for the study. Informed consent in written form was taken after explaining the research purpose along with the associated participation benefits and risks to the individuals. Participants were included in the study after considering inclusion and exclusion criteria. Baseline data was obtained, by performing 180 degree test, Figure of eight, Berg balance scale, Time up and Go (TUG), and 10 meter walk (10MWT) for Turning, Balance, Cadence, and Gait Speed respectively, then participants underwent an intervention phase of 6 weeks (3 days per week on alternate days). After completion of sessions, post-assessment was done for evaluation of turning, balance and gait.
- Conditions
- Stroke
- Being tested
- Turning based specific training with rhythmic auditory stimulation (RAS), Turning based specific training without rhythmic auditory stimulation (RAS)
- Keywords
- post stroke, rhythmic auditory stimulation, turning based specific training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turning based specific training with rhythmic auditory stimulation (RAS)Other
The study involved an experimental group that underwent a 6-week turning-based training with rhythmic auditory stimulation (TBST-RAS), performed three times a week on alternate days. The purpose was to improve motor control and walking abilities through rhythmic auditory cues, specifically adjusting the metronome's beat to the patient's cadence.
Week 1: Patients performed turning exercises around a cone and walking with visual cues at 5% rhythmic auditory cue intensity, with rest periods.
Weeks 2-3: The intensity of rhythmic auditory cues increased to 10%, and patients engaged in cone turning, figure-of-eight walking, and walking with visual cues, with rest breaks in between.
Weeks 4-5: Rhythmic auditory cue intensity increased to 15%. Exercises included cone turning, figure-of-eight walking, walking with visual cues, multidirectional stepping, and rest periods.
Week 6: The final week involved exercises with a further increase in rhythmic auditory cue intensity to 20%. The exercise
Turning based specific training without rhythmic auditory stimulation (RAS)Other
The control group underwent 6 weeks of turning-based specific training without rhythmic auditory stimulation (TBST), performed three times a week on alternate days. The training followed this pattern:
Week 1: Patients began with cone turning for 5 minutes, followed by 2 minutes of rest. Then, they walked with visual cues for 5 minutes, also without rhythmic auditory stimulation.
Weeks 2-3: The exercises continued with cone turning and figure-of-eight walking for 5 minutes each, with 2-minute rest periods in between. Patients also walked with visual cues for 5 minutes without RAS.
Weeks 4-5: The exercises included cone turning, figure-of-eight walking, walking with visual cues, and multidirectional stepping (forward, backward, laterally), all for 5 minutes each, with rest periods between exercises.
Week 6: In the final week, the duration of cone turning and figure-of-eight walking was reduced to 3 minutes, but the exercises still had 2-minute rest periods in between. Patients also p
| Study group | Role | What they receive |
|---|---|---|
| Turning based training without RAS | Active comparator | The participants will receive turning based training without RAS, 3 days per week on alternate days for turning, balance and gait improvement. Receives: Other: Turning based specific training without rhythmic auditory stimulation (RAS) |
| Turning based training with RAS | Experimental | The participants will receive turning based training with RAS, 3 days per week on alternate days for turning, balance and gait improvement. Receives: Other: Turning based specific training with rhythmic auditory stimulation (RAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Turning assessment
180 degree turn test will be used. piece of colored tape placed on floor to mark starting point, participant will be asked to turn 180° on spot from standing start position \& within a designated marked area on floor.
The starting point is marked with a piece of colorful tape on the floor, and the participant is then told to stand with their feet pointed in that direction. After that, they are then instructed to immediately turn 180 degrees from the starting position while standing in a certain, indicated area on the floor. The number of steps required to turn 180 degrees will be counted after the subject is instructed to turn "as fast as he/she can." There will be three rotations in each direction, with a one-minute of break in between. The chance of falling increases with more than five steps. About three seconds is the meantime
Measured: 6 weeks
Turning assessment
Through figure of 8. participant will walk in figure of 8 shape around 2 cones (Clockwise \& anti-clockwise)
Measured: 6 weeks
Balance
The Berg Balance Scale is 14 item scale, assesses the balance of patients with neurological disorders. Performance is assessed on different tasks and each task is graded with a 5- point ordinal scale ranging from 0 to 4, Maximum score à 56 points à adequate postural balance \& no risk of falls. Score equal to or less than 45 points indicates risk of fall. Between 56 \& 41 points, indicate a low risk of falling, between 40 \& 21 points a medium risk of falling, \& between 20 and 0 points a high risk of falling.
Measured: 6 weeks
Balance
Timed up and go test. It measures the time taken for an individual to rise from a chair, walk 3 meters, turn, walk back and sit down
Measured: 6 weeks
Cadence
10 meter walk test
Measured: 6 weeks
Gait speed
10 meter walk test. Mark off 10 m on floor with tape, time in sec how long it takes for patient to walk in 10 meter, having them start few feet before the line and keep going a few feet after the line. calculate in Meters/minute
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start18 Apr 2024
- Primary completion20 Dec 2024
- Study completion30 Dec 2024
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 Foundation University IslamabadThe 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
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818188
- Sponsor's protocol ID
- FUI/CTR/2024/62
- Status last verified
- Jan 2025
- First submitted
- 27 Jan 2025
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rhythmic Auditory Stimulation(RAS) on Turning in Post-stroke Patients
- ClinicalTrials.gov ID
- NCT06818188
- Acronym / sponsor ID
- FUI/CTR/2024/62
- Conditions
- Stroke
- Keywords
- post stroke, rhythmic auditory stimulation, turning based specific training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 10 Feb 2025 (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.
As, stroke is the second leading cause of death and disability globally, leads to postural changes, disturbance in balance, increase fall risks, \& gait dysfunctions, affecting daily activities and walking ability.As, turning is the major component of ambulation. But this difficulty in post stroke results in increased fall risk.Stroke survivors encounter multiple gait abnormalities, which increases difficulty in changing direction.Multiple studies have reported that, RAS with beats of metronome is an effective intervention on balance \& gait patterns i-e stride length, gait speed, \& symmetry in post-stroke patients .With little evidence available targeting comparative effectiveness with \& without RAS on turning in post-stroke patients. This study will fill this gap, to determine the effect on changing direction, with \& without RAS and will be helpful in providing evidence to literature, will provide treatment protocol for turning in gait.
Detailed description
CHAPTER III OBJECTIVES OF STUDY
- To determine the effect on turning in post-stroke patients with and without rhythmic auditory stimulation (RAS)
- To determine the effect on balance in post-stroke patients with and without rhythmic auditory stimulation (RAS)
- To determine the effect on cadence in post-stroke patients with and without rhythmic auditory stimulation (RAS)
- To determine the effect on gait speed in post-stroke patients with and without rhythmic auditory stimulation (RAS)
HYPOTHESIS OF STUDY
ALTERNATE HYPOTHESIS:
- HA: There is a statistically significant difference on turning in post-stroke patients with and without RAS i-e P<0.5
- HA: There is a statistically significant difference on balance in post-stroke patients with and without RAS i-e P<0.5
- HA: There is a statistically significant difference on cadence in post-stroke patients with and without RAS i-e P<0.5 4:HA: There is a statistically significant difference on gait speed in post-stroke patients with and without RAS i-e P<0.5
NULL HYPOTHESIS:
- HO: There is no statistically significant difference on turning in post-stroke patients with and without RAS i-e P>0.5
- HO: There is no statistically significant difference on balance in post-stroke patients with and without RAS i-e P>0.5
- HO: There is no statistically significant difference on cadence in post-stroke patients with and without RAS i-e P>0.5
- HO: There is no statistically significant difference on gait speed in post-stroke patients with and without RAS i-e P>0.5
Sample Selection Criteria:
Recruitment was based on the inclusion and exclusion criteria, as below:
Inclusion Criteria:
Age 45-60 years Male and Females both Sub-acute and chronic ischemic stroke patient (MCA >6months) Mini Mental State Examination score of 25 or higher Functional Ambulation Category (2-3) Berg Balance scale, score of 40-50
Exclusion Criteria:
Hemorrhagic stroke Case or history of epilepsy Patients, having other neurological conditions, Alzheimer, Parkinson \& Dementias
RANDOMIZATION \& ALLOCATION:
Recruited participants were allocated to the experimental and the control group through simple random sampling technique using coin toss method.
Experimental group has received Turning based specific training with Rhythmic Auditory Stimulation (TBST-RAS).
Control group has received Turning based specific training without Rhythmic Auditory Stimulation (TBST).
BLINDING:
This study was non-blinded.
DATA COLLECTION PROCEDURE:
Before commencing data collection, we obtained ethical approval from ERC Foundation University Islamabad, following which approval from the higher authorities of Fauji Foundation Hospital Rawalpindi was taken. Participants were approached during their free time and referred by medical OPD who were willing to volunteer for the study. Informed consent in written form was taken after explaining the research purpose along with the associated participation benefits and risks to the individuals. Participants were included in the study after considering inclusion and exclusion criteria. Baseline data was obtained, by performing 180 degree test, Figure of eight, Berg balance scale, Time up and Go (TUG), and 10 meter walk (10MWT) for Turning, Balance, Cadence, and Gait Speed respectively, then participants underwent an intervention phase of 6 weeks (3 days per week on alternate days). After completion of sessions, post-assessment was done for evaluation of turning, balance and gait.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Turning based training without RAS | Active comparator | Other: Turning based specific training without rhythmic auditory stimulation (RAS)The participants will receive turning based training without RAS, 3 days per week on alternate days for turning, balance and gait improvement. |
| Turning based training with RAS | Experimental | Other: Turning based specific training with rhythmic auditory stimulation (RAS)The participants will receive turning based training with RAS, 3 days per week on alternate days for turning, balance and gait improvement. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 45-60 years
- Male \& Females both
- Sub-acute \& chronic ischemic stroke patient (MCA >6months)
- Mini Mental State Examination score of 25 or higher
- Functional Ambulation Category score 2-3
Key exclusion criteria (3 listed)
- Hemorrhagic stroke
- Case or history of epilepsy
- Patients, having other neurological conditions, Alzheimer, Parkinson \& Dementias
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 |
|---|---|---|
| Turning based specific training with rhythmic auditory stimulation (RAS)The study involved an experimental group that underwent a 6-week turning-based training with rhythmic auditory stimulation (TBST-RAS), performed three times a week on alternate days. The purpose was to improve motor control and walking abilities through rhythmic auditory cues, specifically adjusting the metronome's beat to the patient's cadence. Week 1: Patients performed turning exercises around a cone and walking with visual cues at 5% rhythmic auditory cue intensity, with rest periods. Weeks 2-3: The intensity of rhythmic auditory cues increased to 10%, and patients engaged in cone turning, figure-of-eight walking, and walking with visual cues, with rest breaks in between. Weeks 4-5: Rhythmic auditory cue intensity increased to 15%. Exercises included cone turning, figure-of-eight walking, walking with visual cues, multidirectional stepping, and rest periods. Week 6: The final week involved exercises with a further increase in rhythmic auditory cue intensity to 20%. The exercise | Other | Turning based training with RAS |
| Turning based specific training without rhythmic auditory stimulation (RAS)The control group underwent 6 weeks of turning-based specific training without rhythmic auditory stimulation (TBST), performed three times a week on alternate days. The training followed this pattern: Week 1: Patients began with cone turning for 5 minutes, followed by 2 minutes of rest. Then, they walked with visual cues for 5 minutes, also without rhythmic auditory stimulation. Weeks 2-3: The exercises continued with cone turning and figure-of-eight walking for 5 minutes each, with 2-minute rest periods in between. Patients also walked with visual cues for 5 minutes without RAS. Weeks 4-5: The exercises included cone turning, figure-of-eight walking, walking with visual cues, and multidirectional stepping (forward, backward, laterally), all for 5 minutes each, with rest periods between exercises. Week 6: In the final week, the duration of cone turning and figure-of-eight walking was reduced to 3 minutes, but the exercises still had 2-minute rest periods in between. Patients also p | Other | Turning based training without RAS |
Primary outcome
Turning assessment
Time frame: 6 weeks
180 degree turn test will be used. piece of colored tape placed on floor to mark starting point, participant will be asked to turn 180° on spot from standing start position \& within a designated marked area on floor. The starting point is marked with a piece of colorful tape on the floor, and the participant is then told to stand with their feet pointed in that direction. After that, they are then instructed to immediately turn 180 degrees from the starting position while standing in a certain, indicated area on the floor. The number of steps required to turn 180 degrees will be counted after the subject is instructed to turn "as fast as he/she can." There will be three rotations in each direction, with a one-minute of break in between. The chance of falling increases with more than five steps. About three seconds is the meantime
Turning assessment
Time frame: 6 weeks
Through figure of 8. participant will walk in figure of 8 shape around 2 cones (Clockwise \& anti-clockwise)
Balance
Time frame: 6 weeks
The Berg Balance Scale is 14 item scale, assesses the balance of patients with neurological disorders. Performance is assessed on different tasks and each task is graded with a 5- point ordinal scale ranging from 0 to 4, Maximum score à 56 points à adequate postural balance \& no risk of falls. Score equal to or less than 45 points indicates risk of fall. Between 56 \& 41 points, indicate a low risk of falling, between 40 \& 21 points a medium risk of falling, \& between 20 and 0 points a high risk of falling.
Balance
Time frame: 6 weeks
Timed up and go test. It measures the time taken for an individual to rise from a chair, walk 3 meters, turn, walk back and sit down
Cadence
Time frame: 6 weeks
10 meter walk test
Gait speed
Time frame: 6 weeks
10 meter walk test. Mark off 10 m on floor with tape, time in sec how long it takes for patient to walk in 10 meter, having them start few feet before the line and keep going a few feet after the line. calculate in Meters/minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Turning based specific training with rhythmic auditory stimulation (RAS) and Turning based specific training without rhythmic auditory stimulation (RAS) in people with Stroke, run by Foundation University Islamabad 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 3 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: finished, as of the sponsor's last update on 10 Feb 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Turning assessment (time frame: 6 weeks). The study lists 6 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 10 Feb 2025; AzTrials last refreshed its copy on 3 Nov 2026.