A comparison between the immediate effects of Hip Flexion Assist Orthosis and conventional Ankle Foot Orthosis on gait parameters in ambulatory multiple sclerosis patients
A comparison between the immediate effects of Hip Flexion Assist Orthosis (HFAO) and conventional Ankle Foot Orthosis (AFO) on gait parameters in ambulatory multiple sclerosis patients. Participants: Multiple sclerosis patients who were members of the Iran MS society and have met the inclusion: Acquiring 2 or 3 points in HA; Age between 20-45 years; Unilateral weakness in lower limb (flexor muscles); Ability of walking without any assistive devices for 2 minutes. Exclusion criteria: No pain; Any open wounds in waist area; Spasticity in the lower extremities; Any obvious deformity in the lower extremities. Sample size: 20. Intervention: AFO and HFAO. Duration of intervention: Almost 40 minutes for measuring the velocity and Symmetry variables. Dependent variables: Velocity, Symmetry, Satisfaction.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206295520N7
Registration date:2012-09-17, 1391/06/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-09-17, 1391/06/27
Registrant information
Name
Mojtaba Kamyab
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 0947
Email address
kamyab@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-01-20, 1391/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between the immediate effects of Hip Flexion Assist Orthosis and conventional Ankle Foot Orthosis on gait parameters in ambulatory multiple sclerosis patients
Public title
A comparison between the effects of Hip Flexion Assist Orthosis and conventional Ankle Foot Orthosis on walking in multiple sclerosis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Acquiring 2 or 3 points in HA; Age between 20-45 years; Unilateral weakness in lower limb (flexor muscles); Ability of walking without any assistive devices for 2 minutes. Exclusion criteria: No pain; Any open wounds in waist area; Spasticity in the lower extremities; Any obvious deformity in the lower extremities.
Age
From 20 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Rehabilitation, Tehran University of Medical Sciences
Street address
School of Rehabilitation, Shahnazari st, Mother Sq., Mirdamad Blvd.
City
Tehran
Postal code
Approval date
2012-01-30, 1390/11/10
Ethics committee reference number
1084/130/د/91
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
Velocity
Timepoint
Just before the intervention and after 5 minutes.
Method of measurement
2MWT
2
Description
Satisfaction
Timepoint
After the interventions
Method of measurement
using the satisfaction questionnaire
3
Description
Symmetry of walking
Timepoint
Just before the intervention and after 5 minutes.
Method of measurement
Using Symetry Index
Secondary outcomes
empty
Intervention groups
1
Description
Hip Flexion Assist Orthosis
Category
Rehabilitation
2
Description
Conventional Ankle Foot Orthosis
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
The Iranian Multiple Sclerosis Society
Full name of responsible person
Street address
Iran MS Society, Shams Alley, Vesal St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice chancellor for research, Dr. Akbar Fotuhi
Street address
Rehabilitation faculty, Shah nazari st, Mohseni sq, Mirdamad blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences, School of Rehabilitation.
Full name of responsible person
Mojtaba Kamyab
Position
Assistant prof / PhD
Other areas of specialty/work
Street address
Orthotics & Prosthetics Dep., School of Rehabilitation, Shahnazari st, Mohseni Sq., Mirdamad Blvd.,
City
Tehran
Postal code
Phone
+98 21 2222 8051
Fax
Email
m-kamyab@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences, School of Rehabilitation.
Full name of responsible person
Mojtaba Kamyab
Position
Assistant prof / PhD
Other areas of specialty/work
Street address
Orthotics & Prosthetics Dep., School of Rehabilitation, Shahnazari St. Mother Sq., Mirdamad Blvd.
City
Tehran
Postal code
Phone
+98 21 2222 8051
Fax
Email
m-kamyab@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)