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

Primary Purpose

Multiple Sclerosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Action Observation Therapy
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Action Observation, gait, Balance

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • School of Rehabilitation Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control group

Action Observation group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Fatigue Assessment Scale (FAS)
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.

Full Information

First Posted
September 14, 2022
Last Updated
September 14, 2022
Sponsor
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05543213
Brief Title
The Effects of Action Observation Therapy (AOT) on Balance and Gait in Patients With Multiple Sclerosis.
Official Title
The Effects of Action Observation Therapy (AOT) on Balance and Gait in Patients With Multiple Sclerosis.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shiraz University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Action Observation, gait, Balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Videos of nature will be shown to them, and exercises similar to those in the intervention group will be practiced with them.
Arm Title
Action Observation group
Arm Type
Active Comparator
Arm Description
In the intervention group, the same exercises related to balance and walking are practiced after watching videos of the exercises
Intervention Type
Behavioral
Intervention Name(s)
Action Observation Therapy
Intervention Description
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 Measure Information:
Title
Berg Balance Scale
Description
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.
Time Frame
30 min
Title
Barthel Index
Description
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.
Time Frame
25 min
Title
Functional Independence Measure (FIM)
Description
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.
Time Frame
20 min
Secondary Outcome Measure Information:
Title
Fatigue Assessment Scale (FAS)
Description
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.
Time Frame
10 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Misagh Rahimi, B.Sc.in OT
Phone
9175574547
Ext
+98
Email
misaghrahimi1995@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Abolghasem Fallahzadeh, PhD in OT
Phone
36271551
Ext
+9871
Email
A_Fallahzadeh@Sums.ac.ir
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Taghi Karimi, PhD in OP
Organizational Affiliation
Full professor of orthotics and prosthetics
Official's Role
Study Chair
Facility Information:
Facility Name
School of Rehabilitation Sciences
City
Shiraz
State/Province
Fars
ZIP/Postal Code
7194733669
Country
Iran, Islamic Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Misagh Rahimi, B.Sc. in OT
Phone
9175574547
Ext
+98
Email
misaghrahimi1995@gmail.com
First Name & Middle Initial & Last Name & Degree
Abolghasem Fallahzadeh, Phd
Phone
36271551
Ext
+9871
Email
A_Fallahzadeh@Sums.ac.ir

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All data will be published in tables in the final article.

Learn more about this trial

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

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