Assessment of the effect of supervised exercise through telerehabilitation on the quality of life and walking of multiple sclerosis patients
Design
Single-blind controlled clinical trial with two parallel arms
38 multiple sclerosis patients with walking disorder (without using an assistive device and if using a one-sided assistive device such as a cane)
and are assigned to two parallel groups using the random sequence generated by the software
Settings and conduct
The intervention group received individualized exercise under the supervision The control group performs exercises with the same exercise protocol in person at the rehabilitation clinic. Exercises are performed 2 days a week for 40 minutes based for 6 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria
Diagnosis of multiple sclerosis based on Mc Donalds criteria
Expanded Disability Status Scale <6
No recurrence of the disease in the last 30 days
Exclusion criteria
Patients with severe disease who are unable to walk
Active phase of the disease
Associated underlying disease
Pregnant women
Intervention groups
The intervention group received individualized exercise, including stretching, aerobics, strength exercises) through video calls during 12 sessions (1 month and a half) and under the supervision of a physical medicine and rehabilitation physicians, and all necessary evaluations and tests before and after the intervention are also done remotely and with the cooperation of the telepartner.
Main outcome variables
Timed Up and Go Test; 2 Minute Walk Test; Multiple Sclerosis Impact Scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180804040685N5
Registration date:2023-04-23, 1402/02/03
Registration timing:registered_while_recruiting
Last update:2023-04-23, 1402/02/03
Update count:0
Registration date
2023-04-23, 1402/02/03
Registrant information
Name
Hamid Reza Fateh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2110
Email address
hr-fateh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-15, 1402/01/26
Expected recruitment end date
2023-06-15, 1402/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of supervised exercise program via telerehabilitation on gait and quality of life in patients with multiple sclerosis
Public title
Effects of telerehabilitation in multiple sclerosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of multiple sclerosis based on Mc Donalds criteria
Expanded Disability Status Scale <6
No recurrence of the disease in the last 30 days
Exclusion criteria:
Patients with severe disease who are unable to walk
Active phase of the disease
Associated underlying disease
Pregnant women
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
The participants are randomly allocated to two parallel groups using the block randomization technique. The block size is six and randomize the allocation of intervention or control within each block can be done by using a random number generator. Once the randomization within each block is completed, assign the participants to their respective intervention or control group based on randomization results to make balance within each block. Then, continue the process for subsequent blocks until all of them are assigned. The blinding and concealment of the randomization process also will be done.
Blinding (investigator's opinion)
Single blinded
Blinding description
Those who evaluate the outcome and those responsible for data collection do not know about the allocation of groups and the information of individuals is given in terms of numbers.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Karger St., Jalal Al Ahmad Street, Shariati hospital
City
Tehran
Province
Tehran
Postal code
14117 13135
Approval date
2023-04-09, 1402/01/20
Ethics committee reference number
IR.TUMS.SHARIATI.REC.1402.006
Health conditions studied
1
Description of health condition studied
Multiple sclerosis rehabilitation, telerehabilitation, walking disabilities, quality of life
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Timed up and go test (TUG), 2-minute walk test (2MWT), multiple sclerosis impact scale-29 (MSIS-29)
Timepoint
Before and immediately after the end of the intervention and after 2 months
Method of measurement
TUG is the time measured with the stopwatch from the time the patient gets up from the chair and walks 3 meters and returns and sits on the chair, and 2MWT is measured with the meter. The distance with maximum amount of walking power in 2 minutes, and the quality of life is measured by MSIS-29 questionnaire.
Before and immediately after the end of the intervention and after 2 months
Method of measurement
Fatigue severity is measured by a questionnaire, static and dynamic balance is measured by a Berg balance questionnaire, and muscle strength is measured by a manual muscle strength test.
Intervention groups
1
Description
Intervention group: The intervention group underwent remote rehabilitation during 12 sessions of 1 month and a half through a designed exercise protocol (including stretching, aerobic, strength exercises) and under the supervision of a physical medicine and rehabilitation doctor via video calls. and all the necessary evaluations and tests before and after the sports intervention are done offline and with the cooperation of the telepartner.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Hamid Reza Fateh
Street address
Shariati Hospital, Jalal Al Ahmad Street, Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
14117 13135
Phone
+98 21 8490 2110
Email
hr-fateh@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamid Reza Fateh
Street address
Shariati Hospital, Department of Physical Medicine and Rehabilitation, Jalal Al Ahmad St., North Kargar St., Tehran
City
Tehran
Province
Tehran
Postal code
14117 13135
Phone
+98 21 8490 2110
Email
hr-fateh@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran University of medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamid Reza Fateh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Shariati Hospital, Jalal Al Ahmad Street, Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 2110
Email
hr-fateh@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamid Reza fateh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Tehran, North Kargar St, Jalal Al Ahmad Street, Shariati Hospital, Physical medicine and rehabilitation department
City
Tehran
Province
Tehran
Postal code
14117 13135
Phone
+98 21 8490 2110
Email
hr-fateh@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamid Reza Fateh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Shariati Hospital, Jalal Al Ahmad Street, Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 2110
Email
hr-fateh@tums.ac.ir
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available