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RecruitingNCT06059742Updated Sep 29, 2023

Action Observation Therapy With and Without Acoustic Stimulation in Post Stroke Gait and Balance

An interventional study of Action Observation Therapy with Rhythmic acoustic stimulation and Action Observation Therapy without Rhythmic acoustic stimulation in Stroke, sponsored by Riphah International University. Recruiting at 1 site in Pakistan. Open to participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-09-29.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2024, 2 years 8 months ago, but the record still lists the study as recruiting.
  • Started Sep 2023; still recruiting 3 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
40 Years to 60 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Stroke

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03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 45 is close to the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Patients diagnosed with other neurological diseases
  • Tumors or neoplasms
  • Cardiopulmonary diseases
  • Patient with impaired cognition
  • Visual and auditory impairments
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    Action Observation Therapy with Acoustic Stimulation

    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

    Other: Action Observation Therapy with Rhythmic acoustic stimulation

  • Active comparator
    Action Observation Therapy Without Acoustic Stimulation

    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

    Other: Action Observation Therapy without Rhythmic acoustic stimulation

Interventions

  • OtherAction Observation Therapy with Rhythmic acoustic stimulation

    Action observation therapy is observing some action and the performing Rhythmic acoustic stimulation is performing movement on the rhythm of beats

  • OtherAction Observation Therapy without Rhythmic acoustic stimulation

    Action observation therapy is observing some action and the performing Rhythmic acoustic stimulation is performing movement on the rhythm of beats

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: week 8

  2. 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.

    Time frame: week 8

  3. 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.

    Time frame: week 8

  4. 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

    Time frame: 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

    Time frame: week 8

07

Study locations

1 of 1 sites recruiting
  • HBS hospital Lehtrar Road Alipur
    Islamabad, 45600, Pakistan
    • Tania Saeed, MS NMPT* · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06059742
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
Sep 29, 2023
Start date
Sep 1, 2023
Primary completion
Jan 30, 2024 (estimated)
Completion
Jan 30, 2024 (estimated)
Last update
Sep 29, 2023

Study contacts

Tania Saeed, MS NMPT*
Contact
taniasaeed1995@gmail.com
0315 6996746
Ayesha Afridi, PhD*
Contact
ayesha.afridi@riphah.edu.pk
0315 5268896
Ayesha Afridi, PhD*
principal investigator · Riphah International University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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