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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06059742
• Other study ID #: Riphah/RCRAHS-ISB/REC/01642
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: September 2023
• Source: Riphah International University
• Contact: Tania Saeed, MS NMPT*
• Phone: 0315 6996746
• Email: taniasaeed1995[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: January 30, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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
• 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

Locations

Country	Name	City	State
Pakistan	HBS hospital Lehtrar Road Alipur	Islamabad

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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