ClinicalTrials.gg
RecruitingNCT05543213Updated Dec 7, 2023

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

An interventional study of Action Observation Therapy in Multiple Sclerosis, sponsored by Shiraz University of Medical Sciences. Recruiting at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-12-07.

Sponsored by Shiraz University of Medical Sciences · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 4 months ago, but the record still lists the study as recruiting.
  • Started Jan 2023; still recruiting 3 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Multiple Sclerosis

Browse trials for

Keywords

  • Action Observation
  • gait
  • Balance
03

In context

Multiple Sclerosis

3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.

This study's planned enrollment of 28 is below the median of 50 across 2,201 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Shiraz University of Medical Sciences is the lead sponsor of 130 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
28 participants (estimated)

Study arms

  • 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

Interventions

  • BehavioralAction 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30 minutes

  2. 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.

    Time frame: 25 minutes

  3. 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.

    Time frame: 20 minutes

Secondary outcomes

  1. 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.

    Time frame: 10 minutes

07

Study locations

1 of 1 sites recruiting
  • School of Rehabilitation Sciences
    Shiraz, Fars 7194733669, Iran, Islamic Republic of
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — All data will be published in tables in the final article.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05543213
Responsible party
Misagh Rahimi (Occupational Therapy expert, Shiraz University of Medical Sciences) — Principal investigator
First posted
Sep 16, 2022
Start date
Jan 1, 2023
Primary completion
Jul 1, 2024 (estimated)
Completion
Oct 1, 2024 (estimated)
Last update
Dec 7, 2023

Study contacts

Misagh Rahimi, B.Sc.in OT
Contact
misaghrahimi1995@gmail.com
9175574547 ext. +98
Abolghasem Fallahzadeh, PhD in OT
Contact
A_Fallahzadeh@Sums.ac.ir
36271551 ext. +9871
Mohammad Taghi Karimi, PhD in OP
study chair · Full professor of orthotics and prosthetics

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion