(1) Objectives: The toe separator orthosis is one of the known methods to prevent the progression of hallux valgus by correcting the big toe alignment and changing plantar pressure. The aim of this study is to assess the effect of toe separator on plantar pressure redistribution in subjects with Hallux Valgus.
(2) Design: quasi-experimental study, single group pre/post test
(3) Setting and conduct: The participants will be chosen among the female students and staff of University of Social Welfare and Rehabilitation Sciences. Plantar pressure will be measured by Pedar-X insole system. Tests were consisted of two walking trials: wearing standard shoe only and shoe with toe separator.
(4) Participants: 20 females with Hallux Valgus will be recruited on base of single nonprobability sampling. All participants will meet the inclusion criteria included having mild to moderate flexible HV. Participants will be excluded from the study if they had experienced traumatic injuries or surgeries in the lower limbs, leg length discrepancy, pathologic condition or neurologic disorder in feet and deformities other than HV in the forefoot
(5) Intervention: The silicon toe separator orthosis Apply to the treatment of hallux valgus. It prevents thumb valgus and control hallux valgus. Participants will be asking to insert this pad between the thumb and second toe and immediate effect of orthosis on plantar pressure will be measured.
(6) Main outcome: The variables including peak pressure, force and contact area will be calculated for five regions in forefoot.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013090314554N1
Registration date:2013-10-19, 1392/07/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-10-19, 1392/07/27
Registrant information
Name
Zahra Safaeepour
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0083
Email address
z.safaeepour@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
investigator
Expected recruitment start date
2013-10-23, 1392/08/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the effect of toe separator orthosis on plantar pressure in subjects with Hallux Valgus
Public title
Effect of toe separator in Hallux valgus subjects
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: having mild to moderate flexible HV; age between 19-44.
Exclusion criteria: experienced traumatic injuries or surgeries in the lower limbs; leg length discrepancy; pathologic condition or neurologic disorder in feet; deformities other than HV in the forefoot.
Age
From 19 years old to 44 years old
Gender
Female
Phase
2-3
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
Ethics committee of University of Social Welfare and Rehabilitation Sciences
Street address
Ebne sina building, Koodakyar Alley, Daneshjoo Blvd, Evin
City
Tehran
Postal code
Approval date
2012-02-11, 1390/11/22
Ethics committee reference number
24192/2/آ/801/90
Health conditions studied
1
Description of health condition studied
Hallux valgus
ICD-10 code
M20.1
ICD-10 code description
Acquired deformities of fingers and toes
Primary outcomes
1
Description
Contact area
Timepoint
Before and after intervention
Method of measurement
Plantar pressure measurement system (pedar)
2
Description
Force
Timepoint
Before and after intervention
Method of measurement
Plantar pressure measurement system (pedar)
3
Description
Peak pressure
Timepoint
Before and after intervention
Method of measurement
Plantar pressure measurement system (pedar)
Secondary outcomes
empty
Intervention groups
1
Description
The silicon toe separator orthosis Apply to the treatment of hallux valgus. It prevents thumb valgus and control hallux valgus deterioration. Participants will be asking to insert this pad between the thumb and second toe and immediate effect of orthosis on plantar pressure will be taken by pedar system.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Maede Farzadi
Street address
Koodakyar Alley, Daneshjoo Blvd, Evin
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Maryam Falsafian
Street address
Koodakyar Alley, Daneshjoo Blvd, Evin
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, University of Social Welfare and Rehabilitation 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
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Zahra Safaeepour
Position
PHD of Biomedical Engineering- Biomechanics
Other areas of specialty/work
Street address
Department of Prosthetics and Orthotics, Koodakyar Alley, Daneshjoo Blvd, Evin
City
Tehran
Postal code
Phone
+98 21 2218 0049
Fax
Email
z.safaeepour@uswr.ac.ir
Web page address
www.uswr.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Maede Farzadi
Position
MS student of Technical Orthopedics
Other areas of specialty/work
Street address
Koodakyar Alley, Daneshjoo Blvd, Evin
City
Tehran
Postal code
Phone
+98 21 7713 2371
Fax
Email
farzadimaede@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Maede Farzadi
Position
MS student of Technical Orthopedics
Other areas of specialty/work
Street address
Koodakyar Alley, Daneshjoo Blvd, Evin
City
Tehran
Postal code
Phone
+98 21 7713 2371
Fax
Email
farzadimaede@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)