Effects of perturbation-based balance training versus traditional
balance training on balance and risk of fall in people with multiple
sclerosis
Design
Randomized clinical trial with two arm parallel group design of 30 participants, double blinded, and randomized by stratified permuted block method.
Settings and conduct
Thirty patients with Multiple Sclerosis will participate in this study that will be conducted in Musculoskeletal Rehabilitation Research Center, Ahvaz Jundishapur University of Medical Sciences, Iran. Participants will be randomized in perturbation training or traditional balance training (control), and will received intervention 3 times per week (20 minutes in each session) for 4 weeks. Pre and post intervention ssessments will be performed by a physical therapist who is blinded to allocation. Also, participants are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: History of falls in past 3 months; Ability to stand independently; Ability to walk independently at least for 100 meters; MMSE more than 24; EDSS below 5/5
Exclusion criteria: Exacerbation of symptoms in past 3 months; Any musculoskeletal or neurological conditions except MS limiting balance or gait; Receiving treatments to improve balance in past 3 months
Intervention groups
Intervention group: receive walking and balance exercises with perturbation;
Control group: receive walking and balance exercises without perturbation; Both group will receive 20-minute individualized (1 trainer to 1 participant) training sessions, 3 times a week for 4 weeks.
Main outcome variables
COP parameters using force plate; Adaptation test; Motor control test; Timed Up and Go; 10 meter walk test; Berg Balance Scale; Activities Specific Balance Confidence scale; Fall Efficacy Scale International; Fall rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140519017752N2
Registration date:2018-10-31, 1397/08/09
Registration timing:prospective
Last update:2018-10-31, 1397/08/09
Update count:0
Registration date
2018-10-31, 1397/08/09
Registrant information
Name
Saeideh Monjezi
Name of organization / entity
Musculoskeletal Rehabilitation Research Center, Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 3101
Email address
negahban-h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of perturbation-based balance training versus traditional balance training on balance and risk of falling in people with multiple sclerosis
Public title
Effects of exercises on balance and falls in patients with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: A definite diagnosis of MS, relapsing-remitting or secondary progressive types, as diagnosed by a neurologist; History of falls in past 3 months; Ability to stand independently; Ability to walk independently at least for 100 meters; Ages between 18-64 years; MMSE more than 24; EDSS below 5/5 Exclusion criteria: Experiencing an exacerbation of symptoms due to relapse within 3 months of the baseline measurement; Any musculoskeletal or neurological conditions except MS limiting balance or gait; Uncorrected Auditory or visual impairment; Pregnancy; Involving in the other planned treatment; Receiving treatments to improve balance in past 3 months
Exclusion criteria:
Age
From 18 years old to 64 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed using stratified permuted block method. The unit of randomization will be the individual, and participant will stratified by the age and gender. An statistical software will be used for generating random sequence, and then sealed envelopes will be used to determine the blocks. For allocation concealment, a person who is not a member of research team will perform the randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
A physiotherapist who has no information about patients' allocation and treatment will perform the assessments. The participants will receive information about their treatment program, but they will not informed if they are in intervention or control group.
A statistician who has no information about patients' allocation and treatment will perform the statistical analysis.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
Ground floor, Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Science
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2018-10-22, 1397/07/30
Ethics committee reference number
ethics.research.ac.ir
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
Static Balance
Timepoint
Before and after intervention (at the end of 4th week)
Method of measurement
Force plate
2
Description
Ability to adapt to unexpected changes in orientation of the support surface
Timepoint
Before and after intervention (at the end of 4th week)
Method of measurement
"Adaptation test" in Computerized Dynamic Posturography system (Neurocom)
3
Description
Effectiveness of the patient’s automatic motor responses to external perturbation
Timepoint
Before and after intervention (at the end of 4th week)
Method of measurement
"Motor Control test" in Computerized Dynamic Posturography system (Neurocom)
4
Description
Dynamic balance
Timepoint
Before and after intervention (at the end of 4th week)
Method of measurement
Time Up and Go Test, 10 meter walk test
5
Description
Functional balance
Timepoint
Before and after intervention (at the end of 4th week)
Method of measurement
Berg balance scale
6
Description
Balance confidence
Timepoint
Before and after intervention (at the end of 4th week)
Method of measurement
Activities Specific Balance Confidence scale
7
Description
Fear of fall
Timepoint
Before and after intervention (at the end of 4th week)
Method of measurement
Fall Efficacy Scale – International
8
Description
Fall rate
Timepoint
Before and after intervention (at the end of 4th week)
Method of measurement
Fall diary
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: receive walking and balance exercises with perturbation; Participants received 20-minute individualized (1 trainer to 1 participant) training sessions, 3 times a week for 4 weeks.
Category
Rehabilitation
2
Description
Control group: receive walking and balance exercises without perturbation; Participants received 20-minute individualized (1 trainer to 1 participant) training sessions, 3 times a week for 4 weeks.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Musculoskeletal Rehabilitation Research Center
Full name of responsible person
Zahra Najarzade
Street address
Musculoskeletal Rehabilitation Research Center, School of Rehabilitation Sciences, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135733133
Phone
+98 61 3374 3101
Email
zahra_najarzade@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Badavi
Street address
Ground floor, Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Science
City
Ahvaz
Province
Khouzestan
Postal code
6135733133
Phone
+98 61 3374 3101
Email
zahra_najarzade@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Saeideh Monjezi
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Musculoskeletal Rehabilitation Research Center, School of Rehabilitation Sciences, Ahvaz Jundishapur
City
Ahvaz
Province
Khouzestan
Postal code
6135733133
Phone
+98 61 1374 3101
Fax
+98 61 1374 3101
Email
saeideh.monjezi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Saeideh Monjezi
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Musculoskeletal Rehabilitation Research Center, School of Rehabilitation Sciences, Ahvaz Jundishapur
City
Ahvaz
Province
Khouzestan
Postal code
6135733133
Phone
+98 61 1374 3101
Fax
+98 61 1374 3101
Email
saeideh.monjezi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Saeideh Monjezi
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Musculoskeletal Rehabilitation Research Center, School of Rehabilitation Sciences, Ahvaz Jundishapur
City
Ahvaz
Province
Khouzestan
Postal code
6135733133
Phone
+98 61 1374 3101
Fax
+98 61 1374 3101
Email
saeideh.monjezi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No detail
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