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

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Action Observation Therapy with Rhythmic acoustic stimulation
Action Observation Therapy without Rhythmic acoustic stimulation
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • HBS hospital Lehtrar Road AlipurRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Action Observation Therapy with Acoustic Stimulation

Action Observation Therapy Without Acoustic Stimulation

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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 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.
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

Secondary Outcome Measures

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

Full Information

First Posted
September 22, 2023
Last Updated
September 22, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT06059742
Brief Title
Action Observation Therapy With and Without Acoustic Stimulation in Post Stroke Gait and Balance
Official Title
The Effects of Action Observation Therapy With and Without Acoustic Stimulation on Balance and Gait Among Stroke Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Action Observation Therapy with Acoustic Stimulation
Arm Type
Experimental
Arm Description
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
Arm Title
Action Observation Therapy Without Acoustic Stimulation
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Action Observation Therapy with Rhythmic acoustic stimulation
Intervention Description
Action observation therapy is observing some action and the performing Rhythmic acoustic stimulation is performing movement on the rhythm of beats
Intervention Type
Other
Intervention Name(s)
Action Observation Therapy without Rhythmic acoustic stimulation
Intervention Description
Action observation therapy is observing some action and the performing Rhythmic acoustic stimulation is performing movement on the rhythm of beats
Primary Outcome Measure Information:
Title
Berg Balance Scale
Description
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
Title
Wisconsin Gait Scale
Description
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
Title
Time Up and Go Test
Description
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
Title
6 Min Walk Test
Description
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 Outcome Measure Information:
Title
Functional Reach Test
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tania Saeed, MS NMPT*
Phone
0315 6996746
Email
taniasaeed1995@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ayesha Afridi, PhD*
Phone
0315 5268896
Email
ayesha.afridi@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayesha Afridi, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
HBS hospital Lehtrar Road Alipur
City
Islamabad
ZIP/Postal Code
45600
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tania Saeed, MS NMPT*

12. IPD Sharing Statement

Plan to Share IPD
No

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

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