Clinical trial of Comparing the immediate effect of both conventional and neoprene modified polypropylene ankle foot orthosis on kinematic parameters of gait in people with foot drop syndrome
Objectives:The main objective of this study was to compare the immediate effects of two types of polypropylene ankle foot orthosis(afo); conventional and modified neoprene on the kinematic parameters of gait in people with drop foot syndrome and functional purpose of providing new approaches in the field of administration of orthosis for patients with drop foot syndrome. This study is a quasi-experimental intervention study. Study population: patients with drop foot syndrome. The inclusion criteria: participants, with a score of 0 or 1 ankle dorsiflexors; one-sided weakness of ankle dorsiflexors muscles, flaccid paralysis of the lower extremities following traumatic nerve injury, aged 25 to 50 years, the ability to walk without assistive devices for a period of 2 min. The exclusion criteria: any pain in the body, existing an open wound in the areas covered by the orthosis, obvious deformity in the lower extremities, disinclination to do more tests. Setting & conduct:the participants, were made to complete a consent form. Each person is expected to walk with both orthoses for 10 min. The tests will be taken 3 times: without orthosis, with solid afo and with neoprane afo changed on the dynamometer kystler, to evaluate the components of the kinetic gait movement. The best example will be selected. The data from these tests will be compared first together and then to the normal foot. Main out come measures: lower limb joint's angles; stance phase duration; swing phase duration
General information
Acronym
Ankle Foot Orthosis(AFO)
IRCT registration information
IRCT registration number:IRCT2015120116810N3
Registration date:2016-05-05, 1395/02/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-05, 1395/02/16
Registrant information
Name
hassan saeedi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 0947
Email address
saeedi.h@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2016-01-23, 1394/11/03
Expected recruitment end date
2016-02-19, 1394/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of Comparing the immediate effect of both conventional and neoprene modified polypropylene ankle foot orthosis on kinematic parameters of gait in people with foot drop syndrome
Public title
Clinical trial of comparing the immediate effect of both conventional and neoprene modified polypropylene ankle foot orthosis on kinematic parameters of gait in people with foot drop syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
The main inclusion criteria were: participants, with a score of 0 or 1 ankle dorsiflexors which cause their foot to be dragged in swing phase, one-sided weaknessof ankle dorsiflexor muscles, flaccid paralysis of the lower extremities following traumatic nerve injury, aged 25 to 50 years, the ability to walk without assistive devices for a period of 2 min. The exclusion criteria were: any painfull pain in the body, existing an open wound in the areas covered by the orthosis, obvious deformity in the lower extremities, disinclination to do more tests.
Age
From 90 years old to 66 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
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of iran university of medical science
Street address
Iran university of medical science, Between Sheikh Fazlolah and Chamran Intersection, West Hemmat Highway, Tehran
City
Tehran
Postal code
Approval date
2015-06-17, 1394/03/27
Ethics committee reference number
IR.IUMS.REC.1394.9211502201
Health conditions studied
1
Description of health condition studied
DROP FOOT
ICD-10 code
M21.3
ICD-10 code description
(Wrist or foot drop (acquired
Primary outcomes
1
Description
Ankle joint angle
Timepoint
Immediate effect
Method of measurement
Using Kistler force plate and motion analyzer system in degrees
2
Description
Knee joint angle
Timepoint
Immediate effect
Method of measurement
Using Kistler force plate and motion analyzer system in degrees
3
Description
Hip joint angle
Timepoint
Immediate effect
Method of measurement
Using Kistler force plate and motion analyzer system in degrees
Secondary outcomes
1
Description
Step length
Timepoint
Immediate effect
Method of measurement
Using Kistler force plate in centimeters
2
Description
Stance during
Timepoint
Immediate effect
Method of measurement
Using Kistler force plate in second
3
Description
Swing during
Timepoint
Immediate effect
Method of measurement
Using Kistler force plate in second
Intervention groups
1
Description
Intervention group 1: drop foot people will walk while wearing modified neoprane orthose in their shoes on kistler force plate to predict the components of the kinetic and kinematic gait . The test process will be explained to the patient and they have to walk with both orthoses for 10 min . After being situated in the corresponding calibration the markers will be placed on bony landmarks and the person starts to walk. In order to detect the markers, the subject wore black trousers, nightwear and light reflective markers will be placed on the fifth metatarsal head, internal and external ankle, tubrasity of calcaneus, medial and latral condyle of femur for both feet. Even the study of the digital camera in the direction of movement is marked and moves will be recorded. The best example of the 3 modes will be selected. The data from these tests will be compared first together and then to the normal foot.
Category
Treatment - Other
2
Description
Intervention Group 2:The Test Will Be Taken While They'll Be Wearing Solid AFO With Their Shoes.
Category
Other
3
Description
Intervention Group 3: The Test Will Be Taken Barefoot
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran University of Medical Sciences and Health Services
Full name of responsible person
Dr. Hassan Saeedi
Street address
School Of Rehabilitation Sciences, Maddadkaran Alley, Shahnazari Street, Mohseni Square, Mirdamad BLVD. , Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Iran University Of Medical Science
Full name of responsible person
Dr. Hassan Saeedi
Street address
School Of Rehabilitation Sciences, Maddadkaran Alley, Shahnazari Street, Mohseni Square, Mirdamad BLVD. , Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Iran University Of Medical Science
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences and Health Services
Full name of responsible person
Dr. Hassan Saeedi
Position
Assistant Professor
Other areas of specialty/work
Street address
School Of Rehabilitation Sciences, Maddadkaran Alley, Shahnazari Street, Mohseni Square, Mirdamad BLVD. , Tehran
City
Tehran
Postal code
Phone
+98 21 2222 8051
Fax
Email
Www.hassan_saeedi2@yahoo.co.uk
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)