The aim of this study is to compare the effects of dynamic and static orthoses on hallux valgus angle, range of motion and pain. The study design is crossover and the participants are both male and female and 19 to 33 years old that are volunteers from the students of Iran University of Medical Sciences that will choose based on single non-probability sampling. A total of 24 subjects will examine. Participant assign to one of the two groups: dynamic orthosis or night splint.
The inclusion criteria including of: mild and moderate hallux valgus (based on Manchester scale), minimum pain level of 2 (based on VAS) and 10% limitation in first metatarsophalangeal joint range of motion (measure by Goniometer). The patients with the history of hallux valgus surgery, any history of orthoses use, diseases such as rheumatoid arthritis, diabetes, gout, leprosy, and neurologic disorders will exclude from the study. All subjects will wear each orthosis for a month and after a one-week wash out period, the second orthosis will be replaced.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201605215520N8
Registration date:2016-07-02, 1395/04/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-02, 1395/04/12
Registrant information
Name
Mojtaba Kamyab
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 0947
Email address
kamyab@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Iran University of Medical Sciences
Expected recruitment start date
2016-06-04, 1395/03/15
Expected recruitment end date
2016-08-12, 1395/05/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To Compare the effects of static and dynamic orthoses on Pain, hallux valgus angle and range of motion in hallux valgus sufferers.
Public title
A comparison between the effects of two types of orthosis in hallux valgus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Mild to moderate hallux valgus (based on Manchester scale); minimum pain level of 2 (based on Visual Analogue Scale); 10% limitation in first metatarsophalangeal joint range of motion (measure by Goniometer); 19 to 33 years old
Exclusion criteria: history of hallux valgus surgery; using orthoses; other affecting diseases such as rheumatoid arthritis, diabetes, gout, leprosy, and neurologic disorders
Age
From 19 years old to 33 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Iran University Of Medical Sciences
Street address
School of Rehabilitaion Sciences, Nezam St, ShahNazari St, Mother Sq.
City
Tehran
Postal code
Approval date
2016-05-17, 1395/02/28
Ethics committee reference number
IR.IUMS.rec.1395.27832
Health conditions studied
1
Description of health condition studied
Hallux Valgus
ICD-10 code
Q66.9
ICD-10 code description
Congenital deformity of feet, unspecified
Primary outcomes
1
Description
Hallux Valgus Angle
Timepoint
Before and after one month follow up
Method of measurement
Goniometer
2
Description
Passive range of motion of first MTP
Timepoint
Before and after one month follow up
Method of measurement
Goniometer
3
Description
Pain
Timepoint
Before and after one month follow up
Method of measurement
Visual Analoge Scale
Secondary outcomes
empty
Intervention groups
1
Description
In this study, two types of static and dynamic orthosis used separately. Every person counts as its own control and is compared with itself. Even a month use of dynamic orthoses after the wash-out period, night splint will use.
Category
Treatment - Other
2
Description
Because the study is cross-over, the conditions for this group are same as the previous group. Even a month use of night splint after the wash-out period, dynamic orthoses will use.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Rehabilitation Sciences, Iran University of Medical Sciences
Full name of responsible person
Mojtaba Kamyab
Street address
Department of Orthotics and prosthetics, School of Rehabilitaion Sciences, Nezam St, ShahNazari St, Mother Sq.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research, Iran University of Medical Sciences
Full name of responsible person
Mojtaba Kamyab
Street address
Department of Orthotics and prosthetics, School of Rehabilitaion Sciences, Nezam St, ShahNazari St, Mother Sq.
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, Iran University of Medical 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
Iran University of Medical Sciences
Full name of responsible person
Mojtaba Kamyab
Position
PhD Orthotics & Prosthetics
Other areas of specialty/work
Street address
Department of Orthotics and prosthetics, School of Rehabilitaion Sciences, Nezam St, ShahNazari St, Mother Sq.
City
Tehran
Postal code
Phone
+98 21 2225 8769
Fax
Email
Mojtaba.kamyab@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mojtaba Kamyab
Position
PhD Orthotics & Prosthetics
Other areas of specialty/work
Street address
Department of Orthotics and prosthetics, School of Rehabilitaion Sciences, Nezam St, ShahNazari St, Mother Sq.