The aim of this study is to determine theeEffect of Posterior Leaf Spring AFO on biomechanics of drop foot in stroke population.
Design
This clinical trial will conduct in only one group in Movafaghian gait analyzis center on 20 drop foot post stroke drop foot population.
Settings and conduct
At the beginning of the examination, the patients were asked to walk at least for 10 to 20 min with their own PLS AFOs/shoes.
After that, retro-reflective markers were set at anatomical landmarks according to Helen Hayes’s method. Then, each one will walk in front of Vicon cameras and on the fKistler orce plate to capture biomechanical parameters.
Data processing will proces by Vicon sof ware.
Participants/Inclusion and exclusion criteria
.The inclusion criteria were a clinically observed unilateral drop-foot using PLS AFO as a routine AFO and ability to walk at least 20 min without assistance
Intervention groups
Obtaining kinetic and kinematic of walking in gait libratory with the use of Posterior Leaf Spring AFO in one session of 60 minute with and without posterior leaf spring AFO
Main outcome variables
Kinetic parameters of walking included the ankle, knee and hip moments and powers
Kinetic parameters of walking included the ankle, knee and hip angles
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190919044818N3
Registration date:2023-07-29, 1402/05/07
Registration timing:prospective
Last update:2023-07-29, 1402/05/07
Update count:0
Registration date
2023-07-29, 1402/05/07
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
2023-08-23, 1402/06/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Posterior Leaf Spring Ankle Foot Orthosis on biomechanical parameters of drop foot post stroke patients
Public title
Efficacy of Ankle Foot Orthosis on stroke
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
unilateral drop-foot
using PLS AFO as a routine AFO
ability to walk at least 20 min without assistance
Exclusion criteria:
severe heart or metabolic disease
previous abnormalities in visual/vestibular functions
emotional instability
previous fracture of both lower limbs
severe poly neuropathy
presence of muscle spasms or contractures in lower extremity joints
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
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 commitee 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
۶۵۱۷۸۳۸۷۳۶
Approval date
2023-07-05, 1402/04/14
Ethics committee reference number
IR.UMSHA.REC.1402.280
Health conditions studied
1
Description of health condition studied
stroke
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The angle of the ankle, knee and hip
Timepoint
Before intervention and immidiatly after intervention
Method of measurement
By using camera
2
Description
Moment of the ankle, knee and hip
Timepoint
Before intervention and immidiatly after intervention
Method of measurement
By using camera and force plate
3
Description
power of the ankle, knee and hip
Timepoint
Before intervention and immidiatly after intervention
Method of measurement
By using camera and force plate
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Obtaining kinetic and kinematic of walking in gait libratory with the use of Posterior Leaf Spring AFO in one session of 60 minute with and without posterior leaf spring AFO
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Gait analysis center of Movafaghian
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
۶۵۱۷۸۳۸۷۳۶
Phone
+98 918 339 9369
Email
ensiehpmd@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokohi
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
۶۵۱۷۸۳۸۷۳۶
Phone
+98 918 339 9369
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 Proffessor
Latest degree
Ph.D.
Other areas of specialty/work
Others
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
۶۵۱۷۸۳۸۷۳۶
Phone
+98 918 339 9369
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
Assossiete Proffessor
Latest degree
Ph.D.
Other areas of specialty/work
Others
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
۶۵۱۷۸۳۸۷۳۶
Phone
+98 918 339 9369
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 Proffessore
Latest degree
Ph.D.
Other areas of specialty/work
Others
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
۶۵۱۷۸۳۸۷۳۶
Phone
+98 918 339 9369
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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is 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
Biomechanical parameters of walking in drop foot foot post stroke
When the data will become available and for how long
Start of acsessperiod from 1403
To whom data/document is available
Researchers
Under which criteria data/document could be used
Performing research in health service system
From where data/document is obtainable
Ensieh Pourhoseingholi, Hamadan university of medical science, orthosis and prosthesis department
What processes are involved for a request to access data/document