Comparison the efficacy of newly designed hinged Ankle Foot Orthosis with solid Ankle Foot Orthosis on center of mass fluctuation in hemiplegic Cerebral Palsy patients
Comparison the efficacy of new articulated Ankle Foot Orthosis with solid Ankle Foot Orthosis on center of mass parameters in cerebral palsy hemiplegia
Design
Clinical trial without blinding and with the sample size of 25 people
Settings and conduct
3D-motion analysis was carried out on 10 meters walk away, and 3 one-way walking trials were performed under three conditions, bare foot, with subjects’ own rigid AFOs and with the HP AFO. Two legs of each participant were tested separately and three successful trials were collected for each leg. To prevent fatigue between each trial, participants were asked to take 5 minute rest. changes in center of mass were calculated by employing the method of Cavana et al. In the current study, the mechanical energy was calculated based on the COM information measured and calculated from the 3D-motion analysis data.
Participants/Inclusion and exclusion criteria
We included Cerebral Palsy hemiplegia participants, who using solid Ankle Foot Orthosis, having ability to walk at independently with or without Ankle Foot Orthosis, with Gross Motion Functional Measurement (GMFM) between 1 to 2, with Plantar flexor spasticity between 1 to 2 according to Ashworth scale , having ability to perform 5 degree dorsiflexion actively or passively. People with cognitive problems, People with injection of botulism toxin in the latest 9 month, People with lower limbs fixed flexion contracture in lower limbs joints were excluded.
Intervention groups
New articulated Ankle Foot Orthosis
Main outcome variables
Mechanical energy including potential and kinetic energy, mechanical positive and negative work, joint power
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190919044818N1
Registration date:2023-03-18, 1401/12/27
Registration timing:prospective
Last update:2023-03-18, 1401/12/27
Update count:0
Registration date
2023-03-18, 1401/12/27
Registrant information
Name
Ensieh Pourhosaingholi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4480 3255
Email address
ensiehpmd@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2023-10-23, 1402/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the efficacy of newly designed hinged Ankle Foot Orthosis with solid Ankle Foot Orthosis on center of mass fluctuation in hemiplegic Cerebral Palsy patients
Public title
Efficacy of Ankle Foot Orthosis on center of mass
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Using solid Ankle Foot Orthosis
Ability to walk at independently with or without Ankle Foot Orthosis
Gross Motion Functional Measurement (GMFM) between 1 to 2
Plantar flexor spasticity between 1 to 2 according to Ashworth scale
Ability to perform 5 degree dorsiflexion actively or passively
Exclusion criteria:
People with cognitive problems
People with Botulism toxin injection in recent 9 month
People with fixed contracture in lower limbs joints
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
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 Commtee 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
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
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 updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ensieh Pourhoseingholi
Position
Assisstant Proffessor
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
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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
No - There is not a plan to make this available
Title and more details about the data/document
Bio mechanical parameters included center of mass, potential energy, kinetic energy, mechanical power
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
Performing more researches in health service system
From where data/document is obtainable
From E mail, Ensieh Pourhosaingholi
What processes are involved for a request to access data/document