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

Sponsor
Riphah International University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06059742
Collaborator
(none)
45
1
2
5
9.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Action Observation Therapy with Rhythmic acoustic stimulation
  • Other: Action Observation Therapy without Rhythmic acoustic stimulation
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effects of Action Observation Therapy With and Without Acoustic Stimulation on Balance and Gait Among Stroke Survivors
Actual Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Jan 30, 2024
Anticipated Study Completion Date :
Jan 30, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

  1. Berg Balance Scale [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

  2. Wisconsin Gait Scale [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.

  3. Time Up and Go Test [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.

  4. 6 Min Walk Test [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

Secondary Outcome Measures

  1. Functional Reach Test [week 8]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 60 Years
Sexes Eligible for Study:
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:
  • Patients diagnosed with other neurological diseases

  • Tumors or neoplasms

  • Cardiopulmonary diseases

  • Patient with impaired cognition

  • Visual and auditory impairments

Contacts and Locations

Locations

Site City State Country Postal Code
1 HBS hospital Lehtrar Road Alipur Islamabad Pakistan 45600

Sponsors and Collaborators

  • Riphah International University

Investigators

  • Principal Investigator: Ayesha Afridi, PhD*, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT06059742
Other Study ID Numbers:
  • Riphah/RCRAHS-ISB/REC/01642
First Posted:
Sep 29, 2023
Last Update Posted:
Sep 29, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 29, 2023