Effect of Rhythmic Auditory Stimulation(RAS) on Turning in Post-stroke Patients

NCT06818188 | Completed

• 1 other identifier: FUI/CTR/2024/62
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

post stroke; rhythmic auditory stimulation; turning based specific training

Outcome Measures

Primary Outcomes (6)

• 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

  6 weeks

• Turning assessment

  Through figure of 8. participant will walk in figure of 8 shape around 2 cones (Clockwise \& anti-clockwise)

  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.

  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

  6 weeks

• Cadence

  10 meter walk test

  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

  6 weeks

Study Arms (2)

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.

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.

Other: Turning based specific training with rhythmic auditory stimulation (RAS)

Interventions

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 training with RAS

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

Turning based training without RAS

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Foundation University Islamabad: lead

Study Sites (1)

Foundation University College of Physical Therapy

Islamabad, 44000, Pakistan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 10, 2025
• Study Start: April 18, 2024
• Primary Completion: December 20, 2024
• Study Completion: December 30, 2024
• Last Updated: February 10, 2025

Record last verified: 2025-01

Locations

PA (1)