Clinical trial NCT06818188: Effect of Rhythmic Auditory Stimulation(RAS) on Turning in Post-stroke Patients
Official title: Effect of Rhythmic Auditory Stimulation(RAS) on Turning in Post-stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: post stroke
rhythmic auditory stimulation
turning based specific training
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 32
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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

1. To determine the effect on turning in post-stroke patients with and without rhythmic auditory stimulation (RAS)
2. To determine the effect on balance in post-stroke patients with and without rhythmic auditory stimulation (RAS)
3. To determine the effect on cadence in post-stroke patients with and without rhythmic auditory stimulation (RAS)
4. To determine the effect on gait speed in post-stroke patients with and without rhythmic auditory stimulation (RAS)

HYPOTHESIS OF STUDY

ALTERNATE HYPOTHESIS:

1. HA: There is a statistically significant difference on turning in post-stroke patients with and without RAS i-e P\<0.5
2. HA: There is a statistically significant difference on balance in post-stroke patients with and without RAS i-e P\<0.5
3. 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:

1. HO: There is no statistically significant difference on turning in post-stroke patients with and without RAS i-e P\>0.5
2. HO: There is no statistically significant difference on balance in post-stroke patients with and without RAS i-e P\>0.5
3. HO: There is no statistically significant difference on cadence in post-stroke patients with and without RAS i-e P\>0.5
4. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Hemorrhagic stroke
* Case or history of epilepsy
* Patients, having other neurological conditions, Alzheimer, Parkinson \& Dementias

Primary outcomes:
measure: Turning assessment
timeFrame: 6 weeks
measure: Turning assessment
timeFrame: 6 weeks
measure: Balance
timeFrame: 6 weeks
measure: Balance
timeFrame: 6 weeks
measure: Cadence
timeFrame: 6 weeks
measure: Gait speed
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Foundation University College of Physical Therapy
Study officials:
References: