Multiple SclerosisNCT05543213
The Effects of Action Observation Therapy (AOT) on Balance and Gait in Patients With Multiple Sclerosis.
A study testing Action Observation Therapy in people with Multiple Sclerosis, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Action Observation Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteIran
- Study dates
- 1 Jan 2023to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
School of Rehabilitation Sciences
Shiraz, Fars, 7194733669
Misagh Rahimi, B.Sc. in OT, 9175574547 ext. +98, misaghrahimi1995@gmail.com
Abolghasem Fallahzadeh, Phd, 36271551 ext. +9871, A_Fallahzadeh@Sums.ac.ir
About this study
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Action Observation Therapy
- Keywords
- Action Observation, gait, Balance
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action Observation TherapyBehavioural
A video clip of a series of exercises is shown to the patients, then they practice them according to mirror neurons and observational learning.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Action Observation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start1 Jan 2023
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Misagh Rahimi, Shiraz University of Medical Sciences
- Investigators
- Mohammad Taghi Karimi, PhD in OP, Study chair, Full professor of orthotics and prosthetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543213
- Sponsor's protocol ID
- 26181
- Status last verified
- Nov 2023
- First submitted
- 14 Sep 2022
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be published in tables in the final article.
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Action Observation Therapy (AOT) on Balance and Gait in Patients With Multiple Sclerosis.
- ClinicalTrials.gov ID
- NCT05543213
- Acronym / sponsor ID
- 26181
- Conditions
- Multiple Sclerosis
- Keywords
- Action Observation, gait, Balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Action Observation TherapyIn the intervention group, the same exercises related to balance and walking are practiced after watching videos of the exercises |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Action Observation TherapyA video clip of a series of exercises is shown to the patients, then they practice them according to mirror neurons and observational learning. | Behavioural | Action Observation group |
Primary outcome
Berg Balance Scale
Time frame: 30 minutes
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
Time frame: 25 minutes
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)
Time frame: 20 minutes
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.
1 secondary outcome
Fatigue Assessment Scale (FAS)
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Individual participant dataSharing planned: No. All data will be published in tables in the final article.
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Taghi Karimi, PhD in OP study chair
Full professor of orthotics and prosthetics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action Observation Therapy in people with Multiple Sclerosis, run by Shiraz University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Misagh Rahimi, B.Sc.in OT (9175574547 ext. +98, misaghrahimi1995@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (time frame: 30 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.