Clinical trial NCT05543213: 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
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Action Observation
gait
Balance
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Berg Balance Scale
timeFrame: 30 minutes
measure: Barthel Index
timeFrame: 25 minutes
measure: Functional Independence Measure (FIM)
timeFrame: 20 minutes
Secondary outcomes:
measure: Fatigue Assessment Scale (FAS)
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: School of Rehabilitation Sciences
state: Fars
Study officials:
affiliation: Full professor of orthotics and prosthetics
name: Mohammad Taghi Karimi, PhD in OP
role: STUDY_CHAIR
References: