Comparison the biomechanical gait efficacy ( kinetic, kinematic and spatiotemporal) newly designed Ankle Foot Orthosis on Multiple sclerosos
Design
Clinical trial, without blinding, phase 2 with 12 patients
Settings and conduct
At the start of examination, fifteen retro reflexive markers were attached based on modified Helen Hyes marker markers placed bilaterally on the anterior and posterior superior iliac spine, the posterior sacrum, medial and lateral femoral condyles. heel, lateral malleolus, top of the second metatarsal phalangeal joint (toe). Then, all stage of the examination was explained to the participants and wants them to walk with self selected walking speed in 10 meters at walkway in two conditions of with shoes only /with the new orthosis and shoes. The patients had 10 min of rest between each trial. Each trial was repeated five times.
Participants/Inclusion and exclusion criteria
Subjects diagnosed with MS (6 months), the extended disability scale EDSS of 4 to 6, unilateral drop foot, endurance to ambulate at least 30 feet continuously with minimal assist or less without the use of an AFO, the maximum spasticity of grade II (Ashworth scale) with plantar flexor muscles, and history of using passive AFO were entered in this study.
Investigating the efficacy of new arthiculated AFO on biomechanical parameters in gait of multiple sclerosis
Public title
Efficacy of Ankle Foot Orthosis on Multiple Sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least 6 months after diagnosed with MS
Extended disability scale between 4 to 6
Unilateral drop foot
Endurance to ambulate at least 30 feet continuously with minimal assist without the use of an AFO
The maximum spasticity of grade II with plantar flexor muscles according ti Ashworth scale
Exclusion criteria:
Significant cardiac or respiratory disease
Musculoskeletal impairments and/or pain that severely limited walking
Fixed flexion contracture or spasticity of the hip, knee and ankle joints
History of surgery, trauma, and fracture in lower limbs
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
12
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committe of Hamadan University of Medical Science
Street address
Department of Orthotics and Prosthetics, School of Rehabilitation Sciences, Hamadan University of Medical Sciences Shahid Fahmideh Aven.., Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838736
Approval date
2022-12-10, 1401/09/19
Ethics committee reference number
IR.UMSHA.REC.1401.781
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
Biomechanical parameters (spatiotemporal, kinematic and kinetic)
Timepoint
Before intervention and after intervention
Method of measurement
Motion analysis system and force plate
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Newly designed spring damper Ankle Foot Orthosis
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
The biomechanical laboratory of the Movaghian Research Centre of Intelligent Neuro-Rehabilitation Te
Full name of responsible person
Ensieh Pourhoseingholi
Street address
Department of Orthotics and Prosthetics, School of Rehabilitation Sciences, Hamadan University of Medical Sciences Shahid Fahmideh Aven.., Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 21 4480 3255
Email
ensiehpmd@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ensieh Pourhoseingholi
Street address
Department of Orthotics and Prosthetics, School of Rehabilitation Sciences, Hamadan University of Medical Sciences Shahid Fahmideh Aven.., Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 21 4480 3255
Email
ensiehpmd@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Ensieh Pourhoseingholi
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthosis and Prosthesis
Street address
Department of Orthotics and Prosthetics, School of Rehabilitation Sciences, Hamadan University of Medical Sciences Shahid Fahmideh Aven.., Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 21 4480 3255
Email
ensiehpmd@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ensieh Pourhoseingholi
Position
Asisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthosis and Prosthesis
Street address
Department of Orthotics and Prosthetics, School of Rehabilitation Sciences, Hamadan University of Medical Sciences Shahid Fahmideh Aven.., Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 21 4480 3255
Email
ensiehpmd@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ensieh Pourhoseingholi
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthosis and Prosthesis
Street address
Department of Orthotics and Prosthetics, School of Rehabilitation Sciences, Hamadan University of Medical Sciences Shahid Fahmideh Aven.., Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 21 4480 3255
Email
ensiehpmd@yahoo.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
No - There is not 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
No - There is not a plan to make this available
Title and more details about the data/document
Spatiotemporal parameters (speed of walking, cadence, step and stride length, step and stride time )
Kinematic parameters (angle of hip, knee and ankle joint)
Kinetic parameters (power and moment of hip, knee and ankle joint)
When the data will become available and for how long
Start of access period from 1403
To whom data/document is available
Researchers
Under which criteria data/document could be used
Research in health service system
From where data/document is obtainable
Ensieh Pourhoseingholi, Hamadan University of Medical Science
What processes are involved for a request to access data/document