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

NCT06059742 | Unknown

• 1 other identifier: Riphah/RCRAHS-ISB/REC/01642
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Functional Reach Test

  week 8

Study Arms (2)

Action Observation Therapy with Acoustic Stimulation

EXPERIMENTAL

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 Without Acoustic Stimulation

ACTIVE COMPARATOR

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

Action Observation Therapy with Rhythmic acoustic stimulation OTHER

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

Action Observation Therapy with Acoustic Stimulation

Action Observation Therapy without Rhythmic acoustic stimulation OTHER

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

Action Observation Therapy Without Acoustic Stimulation

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

HBS hospital Lehtrar Road Alipur

Islamabad, 45600, Pakistan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Ayesha Afridi, PhD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tania Saeed, MS NMPT*

CONTACT

0315 6996746; taniasaeed1995@gmail.com

Ayesha Afridi, PhD*

CONTACT

0315 5268896; ayesha.afridi@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: September 29, 2023
• Study Start: September 1, 2023
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)