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

NCT ID: NCT05543213

Last Updated: 2023-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-10-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Multiple Sclerosis

Keywords

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Action Observation gait Balance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Control group

Videos of nature will be shown to them, and exercises similar to those in the intervention group will be practiced with them.

Group Type NO_INTERVENTION

No interventions assigned to this group

Action Observation group

In the intervention group, the same exercises related to balance and walking are practiced after watching videos of the exercises

Group Type ACTIVE_COMPARATOR

Action Observation Therapy

Intervention Type BEHAVIORAL

A video clip of a series of exercises is shown to the patients, then they practice them according to mirror neurons and observational learning.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shiraz University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Misagh Rahimi

Occupational Therapy expert

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohammad Taghi Karimi, PhD in OP

Role: STUDY_CHAIR

Full professor of orthotics and prosthetics

Locations

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School of Rehabilitation Sciences

Shiraz, Fars, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Misagh Rahimi, B.Sc.in OT

Role: CONTACT

Phone: 9175574547

Email: [email protected]

Abolghasem Fallahzadeh, PhD in OT

Role: CONTACT

Phone: 36271551

Email: [email protected]

Facility Contacts

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Misagh Rahimi, B.Sc. in OT

Role: primary

Abolghasem Fallahzadeh, Phd

Role: backup

Other Identifiers

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26181

Identifier Type: -

Identifier Source: org_study_id