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

NCT05543213 | Unknown DMC

• 1 other identifier: 26181
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Action Observation; gait; Balance

Outcome Measures

Primary Outcomes (3)

• Berg Balance Scale

  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.

  30 minutes

• Barthel Index

  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.

  25 minutes

• Functional Independence Measure (FIM)

  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.

  20 minutes

Secondary Outcomes (1)

• Fatigue Assessment Scale (FAS)

  10 minutes

Study Arms (2)

Control group

NO INTERVENTION

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

Action Observation group

ACTIVE COMPARATOR

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

Behavioral: Action Observation Therapy

Interventions

Action Observation Therapy 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.

Action Observation group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

Study Sites (1)

School of Rehabilitation Sciences

Shiraz, Fars, 7194733669, Iran

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Mohammad Taghi Karimi, PhD in OP

  Full professor of orthotics and prosthetics

  STUDY CHAIR

Central Study Contacts

Misagh Rahimi, B.Sc.in OT

CONTACT

9175574547; misaghrahimi1995@gmail.com

Abolghasem Fallahzadeh, PhD in OT

CONTACT

36271551; A_Fallahzadeh@Sums.ac.ir

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Occupational Therapy expert

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 16, 2022
• Study Start: January 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: October 1, 2024
• Last Updated: December 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)