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The Effects of Action Observation Therapy (AOT) on Balance and Gait in Patients With Multiple Sclerosis.

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ClinicalTrials.gov Identifier: NCT05543213
Recruitment Status : Not yet recruiting
First Posted : September 16, 2022
Last Update Posted : September 16, 2022
Sponsor:
Information provided by (Responsible Party):
Misagh Rahimi, Shiraz University of Medical Sciences

Brief Summary:
Action observation therapy is a new method in rehabilitation that causes motor retraining by activating mirror neurons while watching the activity on the screen and then practicing them. We will use action observation therapy to improve balance and walking in MS patients.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Action Observation Therapy Not Applicable

Detailed Description:

Multiple sclerosis (MS) is an inflammatory disease of the brain and spinal cord caused by damage to myelin.

While the underlying cause of this disease is unknown, a significant relationship has been reported between a series of (CNS) neurons of the central nervous system, immune factors, genetics, and viruses. The primary complaint of MS patients is movement problems, particularly walking disorders, which greatly affect their quality of life, and its improvement is one of the main goals of rehabilitation. Action observation therapy is a new approach. It is used to treat neurological disorders such as cerebral palsy, Parkinson's disease, strokes, and multiple sclerosis.

In this method, a video of some purposeful movements and activities recorded by healthy people doing them is shown to the patient, then the person must try to imitate and perform those actions, which causes movement retraining and memory recall. Based on the studies conducted on the effectiveness of neurological treatment methods and proving the effectiveness of this method on other conditions, also considering the involvement of the nervous system in MS and the lack of related studies, we conducted this study with regard to To design a low cost, availability, and ease of use therapeutic method on balance and walking in patients with multiple sclerosis.

This study will be conducted on two groups of MS patients. after passing 30 minutes of usual rehabilitation by the blind therapist. One group will watch videos related to action observation exercises and then practice, and for the second group, a video of natural scenery will be shown for the same length of time, then they will practice exercises similar to the first group.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Action Observation Therapy (AOT) on Balance and Gait in Patients With Multiple Sclerosis.
Estimated Study Start Date : January 1, 2023
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : July 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control group
Videos of nature will be shown to them, and exercises similar to those in the intervention group will be practiced with them.
Active Comparator: Action Observation group
In the intervention group, the same exercises related to balance and walking are practiced after watching videos of the exercises
Behavioral: Action Observation Therapy
A video clip of a series of exercises is shown to the patients, then they practice them according to mirror neurons and observational learning.




Primary Outcome Measures :
  1. Berg Balance Scale [ Time Frame: 30 min ]
    The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.

  2. Barthel Index [ Time Frame: 25 min ]
    The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL). Ten variables describing ADL and mobility are scored, a higher number being a reflection of greater ability to function independently following hospital discharge.Time taken and physical assistance required to perform each item are used in determining the assigned value of each item. The Barthel Index measures the degree of assistance required by an individual on 10 items of mobility and self care ADL.

  3. Functional Independence Measure (FIM) [ Time Frame: 20 min ]

    The Functional Independence Measure (FIM) is an instrument that was developed as a measure of disability for a variety of populations and is not specific to any diagnosis. The FIM instrument

    Includes measures of independence for self-care, including sphincter control, transfers, locomotion, communication, and social cognition.

    Is an 18-item, seven-level, ordinal scale intended to be sensitive to changes over the course of a comprehensive inpatient medical rehabilitation program.

    Uses the level of assistance an individual needs to grade functional status from total independence to total assistance).

    The tool is used to assess a patient's level of disability as well as a change in patient status in response to rehabilitation or medical intervention.



Secondary Outcome Measures :
  1. Fatigue Assessment Scale (FAS) [ Time Frame: 10 min ]
    The Fatigue Assessment Scale (FAS) is a 10-item self-report scale evaluating symptoms of chronic fatigue. The FAS treats fatigue as a unidimensional construct and does not separate its measurement into different factors. However, in order to ensure that the scale evaluates all aspects of fatigue, it measures both physical and mental symptoms.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of spastic primary progressive, secondary progressive, relapsing-remitting MS
  • EDSS (Extensive Disability Status Scale) Score between 3 and 6
  • MMSE (Mini-mental state examination) test score> 24

Exclusion Criteria:

  • Recurrence of MS during 3 months before intervention
  • Pregnancy and lactation
  • Having a psychiatric disorder or drug/alcohol abuse
  • Changes in the symptoms of MS during the study period
  • Inability to sit without torso support
  • Inability to stand for at least 10 seconds with support
  • Other neurological or orthopedic diseases of the lower extremities (musculoskeletal diseases, severe osteoarthritis, peripheral neuropathy, joint replacement)
  • Cardiovascular diseases (recent myocardial infarction, heart failure, uncontrolled hypertension, orthostatic hypotension)
  • participation in other clinical studies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05543213


Contacts
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Contact: Misagh Rahimi, B.Sc.in OT 9175574547 ext +98 misaghrahimi1995@gmail.com
Contact: Abolghasem Fallahzadeh, PhD in OT 36271551 ext +9871 A_Fallahzadeh@Sums.ac.ir

Locations
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Iran, Islamic Republic of
School of Rehabilitation Sciences
Shiraz, Fars, Iran, Islamic Republic of, 7194733669
Contact: Misagh Rahimi, B.Sc. in OT    9175574547 ext +98    misaghrahimi1995@gmail.com   
Contact: Abolghasem Fallahzadeh, Phd    36271551 ext +9871    A_Fallahzadeh@Sums.ac.ir   
Sponsors and Collaborators
Shiraz University of Medical Sciences
Investigators
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Study Chair: Mohammad Taghi Karimi, PhD in OP Full professor of orthotics and prosthetics
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Responsible Party: Misagh Rahimi, Occupational Therapy expert, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT05543213    
Other Study ID Numbers: 26181
First Posted: September 16, 2022    Key Record Dates
Last Update Posted: September 16, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All data will be published in tables in the final article.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Misagh Rahimi, Shiraz University of Medical Sciences:
Action Observation
gait
Balance
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases