Protocol summary

Study aim
Evaluation of the effect of Action Observation on Balance and kinematic parameters of gait using a gait analysis system in patients with Multiple Sclerosis (MS)
Design
A clinical trial with parallel groups including an action observation group and a control group, single-blind, randomized on 24 patients with MS.
Settings and conduct
MS patients will be included in the study if they qualify and will be randomly assigned to an intervention or control group. This study will be conducted under single-blind conditions. The assessor and therapist that assess and provide routine rehabilitation, evaluate and treat patients in separate rooms based on the assumption that each patient has undergone action observation therapy.
Participants/Inclusion and exclusion criteria
MS patients who have an EDSS score between 3 and 6, an MMSE score of more than 24, age between 18 to 45 years will be included in the study. recurrence of the disease 3 months before the intervention, pregnancy, and breastfeeding, inability to sit without support, inability to stand for at least 10 seconds with support, Other orthopedic and neurologic diseases will be excluded.
Intervention groups
The intervention group watched a 15-minute video from different angles containing exercises commonly used to improve walking in people with MS and then performed the same exercises with the help of an experienced therapist. The control group will watch a 15-minute video containing a video depicting landscapes and then perform the same exercises as the intervention group under the same conditions. The interventions will last three sessions a week for 6 weeks.
Main outcome variables
The velocity of the center of pressure; Length, width, and time of step; Stride length and time; stance time; swing time; walking speed; cadence; Kinematics of the pelvis, hip, knee, and ankle joints

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220613055155N1
Registration date: 2022-11-12, 1401/08/21
Registration timing: prospective

Last update: 2022-11-12, 1401/08/21
Update count: 0
Registration date
2022-11-12, 1401/08/21
Registrant information
Name
Misagh Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 1551
Email address
misaghrahimi1995@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-07-23, 1402/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Action Observation therapy (AOT) on balance and kinematic parameters of gait in patients with multiple sclerosis.
Public title
The effect of Action Observation on gait of persons with multiple sclerosis (MS)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of spastic primary progressive, secondary progressive, relapsing-remitting MS Extensive Disability Status Scale (EDSS) Score between 3 and 6 Mini–mental state examination (MMSE) test score more than 24
Exclusion criteria:
Recurrence of MS during 3 months before intervention Pregnancy and lactation Having a psychiatric disorder or drug / alcohol abuse 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
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization method will be used to assign people into two groups, which will be done by selecting numbered papers (1-24) that are inside sealed envelopes, and patients will be assigned to intervention and control groups. The patient will choose one of the envelopes, even numbers are assigned to the intervention group and odd numbers to the control group. Then the selected envelope will be removed and this procedure will be repeated for the next patient.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study was designed as a single-blinded study. In this intervention, the health care personnel or the clinical caregiver and the person who is in charge of the evaluation are kept blind. Before the trial started, participants were randomly divided into two groups, and other researchers were unaware of the distribution of patients. The clinical caregiver provides routine rehabilitation in the therapeutic exercise room, separate from the place where the activity observation intervention is offered, assuming that all participants will be subjected to the new intervention. Participants are asked not to discuss the movie they saw with the clinical caregiver. In addition, the evaluator evaluates the participants in a separate laboratory presuming all patients will undergo observation. We ask patients not to discuss the film they have seen with the evaluator. The evaluator and clinical supervisor are unaware of what is happening in the new intervention room as the leading researcher presents videos in a separate room.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz Rehabilitation School
Street address
School of Rehabilitation, Abiverdi 1 St., Chamran Blvd., Shiraz, Fars, Iran
City
Shiraz
Province
Fars
Postal code
7194733669
Approval date
2022-07-20, 1401/04/29
Ethics committee reference number
IR.SUMS.REHAB.REC.1401.021

Health conditions studied

1

Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis

Primary outcomes

1

Description
The center of pressure velocity (COPV)
Timepoint
at the beginning of the study (before the start of the intervention), after the end of the intervention (6 weeks after the start of the intervention) and one month after the end of the intervention
Method of measurement
Force plate

2

Description
step length
Timepoint
At the beginning of the study (before the start of the intervention), after the end of the intervention (6 weeks after the start of the intervention), and one month after the end of the intervention
Method of measurement
3D Motion capture cameras and gait analyzing system

3

Description
step width
Timepoint
At the beginning of the study (before the start of the intervention), after the end of the intervention (6 weeks after the start of the intervention), and one month after the end of the intervention
Method of measurement
3D Motion capture cameras and gait analyzing system

4

Description
step time
Timepoint
At the beginning of the study (before the start of the intervention), after the end of the intervention (6 weeks after the start of the intervention) and one month after the end of the intervention
Method of measurement
3D Motion capture cameras and gait analyzing system

5

Description
Gait velocity (meters per second)
Timepoint
At the beginning of the study (before the start of the intervention), after the end of the intervention (6 weeks after the start of the intervention) and one month after the end of the intervention
Method of measurement
3D Motion capture cameras and gait analyzing system

6

Description
stride length
Timepoint
At the beginning of the study (before the start of the intervention), after the end of the intervention (6 weeks after the start of the intervention) and one month after the end of the intervention
Method of measurement
3D Motion capture cameras and gait analyzing system

7

Description
Stride time
Timepoint
At the beginning of the study (before the start of the intervention), after the end of the intervention (6 weeks after the start of the intervention) and one month after the end of the intervention
Method of measurement
3D Motion capture cameras and gait analyzing system

8

Description
Gait cadence (steps per minute)
Timepoint
At the beginning of the study (before the start of the intervention), after the end of the intervention (6 weeks after the start of the intervention) and one month after the end of the intervention
Method of measurement
3D Motion capture cameras and gait analyzing system

9

Description
ankle kinematics
Timepoint
At the beginning of the study (before the start of the intervention), after the end of the intervention (6 weeks after the start of the intervention) and one month after the end of the intervention
Method of measurement
3D Motion capture cameras and gait analyzing system

10

Description
knee kinematics
Timepoint
At the beginning of the study (before the start of the intervention), after the end of the intervention (6 weeks after the start of the intervention) and one month after the end of the intervention
Method of measurement
3D Motion capture cameras and gait analyzing system

11

Description
hip kinematics
Timepoint
At the beginning of the study (before the start of the intervention), after the end of the intervention (6 weeks after the start of the intervention) and one month after the end of the intervention
Method of measurement
3D Motion capture cameras and gait analyzing system

12

Description
Pelvis kinematics
Timepoint
At the beginning of the study (before the start of the intervention), after the end of the intervention (6 weeks after the start of the intervention) and one month after the end of the intervention
Method of measurement
3D Motion capture cameras and gait analyzing system

13

Description
stance time
Timepoint
At the beginning of the study (before the start of the intervention), after the end of the intervention (6 weeks after the start of the intervention) and one month after the end of the intervention
Method of measurement
3D Motion capture cameras and gait analyzing system

14

Description
swing time
Timepoint
At the beginning of the study (before the start of the intervention), after the end of the intervention (6 weeks after the start of the intervention) and one month after the end of the intervention
Method of measurement
3D Motion capture cameras and gait analyzing system

Secondary outcomes

empty

Intervention groups

1

Description
Action observation intervention group: This group includes 12 patients with MS who are included in the study based on the inclusion criteria. In the first stage, the subjects of this group undergo a 30-minute routine rehabilitation, which will be performed by a blind occupational therapist familiar with the MS rehabilitation program. The physical training programs will focus on stretching exercises, balance, walking, and muscle strengthening. Then, in the second stage, the main researcher shows the video clips to the patients for 15 minutes. Then all the displayed exercises will be practiced by the patient and the main researcher for 15 minutes. To watch videos, a person sits on a comfortable chair in front of a 19-inch monitor 100 cm away from them. While watching the video, people are asked to watch carefully and do nothing. The videos in the intervention group include exercises related to walking, crossing an obstacle, going up and down stairs, and standing up and sitting on a chair, which was performed by a healthy adult man and was taken from the front, back, and side angles. Each exercise is shown for three minutes and the person is given one-minute rest between each series of videos. Both groups will receive three treatment sessions per week for six consecutive weeks.
Category
Rehabilitation

2

Description
control group: This group includes 12 patients with MS who are included in the study based on the inclusion criteria after receiving a 30-minute routine rehabilitation that includes stretching, strengthening, and balance exercises, in the second stage, videos include images of landscapes. They will observe nature videos, without any movement content for 15 minutes, and then they will receive the same exercise activities as the action observation intervention group. In fact, patients in the control group will receive the same rehabilitation protocol as the intervention group. During the sessions, they will simultaneously watch a video containing images of natural landscapes without moving content. In order to comply with ethical issues, a few Action observation treatment sessions will be conducted after the project's completion. Both groups will receive three treatment sessions per week for six consecutive weeks.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz Rehabilitation School
Full name of responsible person
Misagh Rahimi
Street address
School of Rehabilitation, Abiverdi 1 St., Chamran Blvd., Shiraz, Fars, Iran
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3627 1551
Email
Misaghrahimi1995@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mahtab Memarpour
Street address
7th Floor, Administration Building of Shiraz University of Medical Sciences Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Fax
Email
memarpour@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Misagh Rahimi
Position
Clinical expert
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
School of Rehabilitation, Abiverdi 1 St., Chamran Blvd., Shiraz, Fars, Iran
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3627 1551
Fax
Email
Misaghrahimi1995@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abolghasem Fallahzadeh Abarghuei
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
School of Rehabilitation, Abiverdi 1 St., Chamran Blvd., Shiraz, Fars, Iran
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3627 1551
Fax
Email
A_Fallahzadeh@Sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Misagh Rahimi
Position
Clinical expert
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
School of Rehabilitation, Abiverdi 1 St., Chamran Blvd., Shiraz, Fars, Iran
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3627 1551
Fax
Email
Misaghrahimi1995@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All the data of this study can be shared after de-identifying the participants.
When the data will become available and for how long
The data of this study will be accessible three months after the results are published.
To whom data/document is available
Researchers from academic and scientific institutions will have access to this study's data
Under which criteria data/document could be used
Using this study does not require any special conditions.
From where data/document is obtainable
To receive data and documents, please refer to Dr. Abolqasem Fallahzadeh, Professor of Shiraz Rehabilitation Faculty. Phone: 07136271551 E-mail: A_Fallahzadeh@Sums.ac.ir Address: Shiraz Faculty of Rehabilitation Sciences, 1 Abivardi Street, Chamran Blvd.
What processes are involved for a request to access data/document
A letter of request is enough to receive data.
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