Protocol summary

Study aim
Examine the impact of the optimized condition on motor learning in MS patients
Design
According to baseline assessments (e.g., walking speed, balance, and, cognitive assessments), patients were randomized into either the optimized or control groups. Following this, all patients participated in the acquisition phase, comprising three blocks of four trials. The instructions for these three blocks were contingent upon the assigned patient group. For the optimal group, patients practiced under EE, AS, or EF conditions in a counterbalanced order
Settings and conduct
The sample of this research included 30 MS patients (male and female) with an age range of 30 to 50 years and a physical disability scale (EDSS) between 2 and 5, who were selected from the patients referred to the MS center in Isfahan. First, in a briefing session, the steps of the exercise program and the duration of its implementation were explained to the participants. Then, in an interview using the sports medicine information questionnaire, the researcher examined the medical records including the attending physician, the drugs used by the patient, and in general their clinical, health and physical activity conditions. The patients were aware that they were participating in a research project, but due to one-way blinding, none of them know about the goals of the researcher and the specific protocol.
Participants/Inclusion and exclusion criteria
1) clinically definitive diagnosis of MS, 2) age > 18, 3) Expanded Disability Status Scale: 2.0–5.0, 4) ability to walk without aid (e.g., cane), 5) Timed Twenty-Five-Foot Walk Test (T25-FW) > 5 seconds, 6) normal cognitive status or absence of dementia was determined through the Mini-Mental State Exam
Intervention groups
optimal group Control group
Main outcome variables
Motor learning, Intrinsic Motivation, Mental effort, Movement-Specific Reinvestment, Positive Affect

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240709062370N2
Registration date: 2024-08-10, 1403/05/20
Registration timing: registered_while_recruiting

Last update: 2024-08-10, 1403/05/20
Update count: 0
Registration date
2024-08-10, 1403/05/20
Registrant information
Name
Hamid Salehi
Name of organization / entity
The university of Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 3793 2577
Email address
salehi@spr.ui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-03, 1403/05/13
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Optimizing motor learning in people with Multiple Sclerosis
Public title
Optimizing motor learning in people with Multiple Sclerosis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
: 1) clinically definitive diagnosis of MS 2) age > 30 3) Expanded Disability Status Scale (EDSS): 2.0–5.0, 4) ability to walk without aid (e.g., cane), 5) Timed Twenty-Five-Foot Walk Test (T25-FW) > 5 seconds 6) normal cognitive status or absence of dementia was determined through the Mini-Mental State Exam (MMSE)
Exclusion criteria:
No modification has been made to disease-modifying medications or medications influencing walk performance and spasticity in the preceding 4 weeks.
Age
From 30 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Data and Safety Monitoring Board
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization method. For this purpose, the participants were listed alphabetically and each participant was assigned numbers one and two from this list. The unit of randomization was individual, and randomization was produced and applied using Excel software and the combination of two commands, SORTBY and ARRAYRAND. By applying this method, each participant will be randomly replaced in the control or optimal group, and the role of all related/unrelated variables in selecting participants in the two groups will be randomly neutralized.
Blinding (investigator's opinion)
Single blinded
Blinding description
Written informed consent document was obtained before participating in the experiment. They had not informed about the purpose of the study.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research ethics committees of University of Isfahan
Street address
The university of Isfahan, Hezar Jarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673444
Approval date
2023-11-12, 1402/08/21
Ethics committee reference number
IR.UI.REC.1402.122

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
Motor learning
Timepoint
Pretest (before intervention)
Method of measurement
Stopwatch

Secondary outcomes

1

Description
intrinsic motivation, Positive affect, mental effort
Timepoint
End of the practice
Method of measurement
Intrinsic Motivation Inventory (IMI), The Movement-Specific Reinvestment Scale (MSRS), The Rating Scale for Mental Effort (RSME), Positive Affect and Negative Affect Scales

Intervention groups

1

Description
Intervention group: one training session including 30 minutes of stepping training under optimal conditions (by providing motivational and attentional variables of optimal theory)
Category
Behavior

2

Description
Control group: one training session including 30 minutes of stepping training under natural (non-optimal) conditions.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
The MS Comprehensive Center in Isfahan
Full name of responsible person
Mr. Torabi
Street address
M.S Isfahan Center, Bahonar St, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
۸۱۳۸۷۵۳۸۷۴
Phone
+98 31 3345 8886
Email
isfms.pr@gmail.com
Web page address
https://esfahanms.ir/fa/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The university of Isfahan
Full name of responsible person
Dr. Hadi Amiri
Street address
The University of Isfahan, Azadi square, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 2003
Email
info@ui.ac.ir
Web page address
https://www.ui.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The university of Isfahan
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
The University of Isfahan
Full name of responsible person
Hamid Salehi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Motor behavior
Street address
The University of Isfahan, Azadi square, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673444
Phone
+98 31 3793 2577
Email
salehi.hamid@gmail.com
Web page address
https://sprold.ui.ac.ir/~salehi/

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Isfahan
Full name of responsible person
Hamid Salehi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Motor behavior
Street address
The University of Isfahan, Azadi square, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3793 2003
Email
salehi.hamid@gmail.com
Web page address
https://sprold.ui.ac.ir/~salehi/

Person responsible for updating data

Contact
Name of organization / entity
The University of Isfahan
Full name of responsible person
Hamid Salehi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Motor behavior
Street address
The University of Isfahan, Azadi square, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673444
Phone
+98 31 3793 2577
Email
salehi.hamid@gmail.com
Web page address
https://sprold.ui.ac.ir/~salehi/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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