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

The Effects of Action Observation Therapy With and Without Acoustic Stimulation on Balance and Gait Among Stroke Survivors

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: Action Observation Therapy with Rhythmic acoustic stimulation; Other: Action Observation Therapy without Rhythmic acoustic stimulation

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 Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tania Saeed, MS NMPT*; Phone Number: 0315 6996746; Email: taniasaeed1995@gmail.com
• Study Contact Backup: Name: Ayesha Afridi, PhD*; Phone Number: 0315 5268896; Email: ayesha.afridi@riphah.edu.pk

Study Locations

• Pakistan
  • Islamabad, Pakistan, 45600
    • Recruiting
    • HBS hospital Lehtrar Road Alipur
    • Principal Investigator: Tania Saeed, MS NMPT*

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	week 8
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.	week 8
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.	week 8
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	week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	week 8

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): January 30, 2024
• Study Completion (Estimated): January 30, 2024

Study Registration Dates

• First Submitted: September 22, 2023
• First Submitted That Met QC Criteria: September 22, 2023
• First Posted (Actual): September 29, 2023

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: Riphah/RCRAHS-ISB/REC/01642

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No