The Effect of a Newly Designed Orthosis with the Capability of Neuromuscular Electrical Stimulation on the Morphology and Strength of Abductor Hallucis Muscle and Correction of Deformity in Women with Mild to Moderate Hallux Valgus Deformity
Evaluation of the effect of designed orthosis with the capability of neuromuscular electrical stimulation on the morphology and strength of the abductor hallucis muscle and correction of deformity in women with mild to moderate hallux vulgus deformity
Design
Randomized clinical Trial with intervention and control groups, Parallel group design, non randomized on 40 participants with mild or moderate hallux valgus deformity and followed for one month
Settings and conduct
Participants will be selected from women referring to the foot clinic or orthotics and prosthetics clinic of the Faculty of Rehabilitation Sciences, Iran University of Medical Sciences. Test conditions and the amount of participation required for individuals will be explained. The volunteers, will sign the consent form. Demographic information will be completed; the necessary assessments will then be made.
Participants/Inclusion and exclusion criteria
Criteria for non-entry:
Have any Metal Parts on the Foot for MRI Examination
History of Orthosis Treatment for Hallux Valgus Deformity
Rigid Flat Foot and Foot Posture Index above 9
Inclusion Criteria:
Bilateral or One Sided Hallux Valgus Deformity at Mild or Moderate Severity
1-10 Score Based on Beck Depression Questionnaire
Age Between 19–44 Years
History of Pain only in the First Metatarsophalangeal Joint for at least One Month
Conscious Consent of Participants
Accept Study Conditions (for example: Not Wearing Inappropriate Shoes)
Intervention groups
One group will apply electrical stimulation and orthosis for 3 weeks and begin exercise and end at the end of the fourth week. The second group will receive the orthosis for four weeks, and then the process of starting a treatment program will be similar to the previous group.
Main outcome variables
Angle؛ intermetatarsal angle؛ volume, cross sectional area and strength of abductor hallucis muscle؛ Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200915048725N1
Registration date:2020-12-03, 1399/09/13
Registration timing:registered_while_recruiting
Last update:2020-12-03, 1399/09/13
Update count:0
Registration date
2020-12-03, 1399/09/13
Registrant information
Name
Maryam Jalali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 0947
Email address
jalali.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-05-21, 1400/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of a Newly Designed Orthosis with the Capability of Neuromuscular Electrical Stimulation on the Morphology and Strength of Abductor Hallucis Muscle and Correction of Deformity in Women with Mild to Moderate Hallux Valgus Deformity
Public title
The Effect of a Newly Designed Orthosis on the Hallux Valgus Deformity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Bilateral or One Sided Hallux Valgus Deformity at Mild or Moderate Severity
1-10 Score Based on Beck Depression Questionnaire
Age Between 19–44 Years
No Rigid Flat Foot and Foot Posture Index (FPI) above 9
History of Pain only in the First Metatarsophalangeal Joint for at least One Month
Conscious Consent of Participants
Accept Study Conditions (for example: Not Wearing Inappropriate Shoes)
Do not Have any Metal Parts on the Foot (Such as Artificial Joints or Any Type of Metal Plate and Bolts) for Magnetic Resonsnce Imaging (MRI)
No History of Orthosis Treatment for Hallux Valgus Deformity
Exclusion criteria:
History of Foot Surgery
Body Mass Index of 30 or more or Very High Weight (100 kg and above)
History of Systemic Diseases Like Rheumatoid Arthritis, Diabetes, Gout, Leprosy; Neurological Disorders and Dislocation and Fracture of Metatarsophalangeal Joints
Experience pain Somewhere other than the First Metatarsophalangeal Joint. For Example, People with Symptomatic Flat Feet and Heel Pain
Age
From 19 years old to 44 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not 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 Sciences
Street address
Golestan Hemmat Dormitory, Faculty of Rehabilitation Sciences, Madadkaran St., Shah Nazari St., Madar Square, Mirdamad Blvd., Tehran. Postal code: 1545913487
City
Tehran
Province
Tehran
Postal code
1545913487
Approval date
2020-07-21, 1399/04/31
Ethics committee reference number
IR.IUMS.FMD.REC.1399.363
Health conditions studied
1
Description of health condition studied
Hallux Valgus Deformity
ICD-10 code
M20.10
ICD-10 code description
Hallux valgus (acquired), unspecified foot
Primary outcomes
1
Description
Hallux Valgus Angle
Timepoint
Before and After of the Intervention
Method of measurement
Goniometer and MRI
Secondary outcomes
1
Description
Abductor Hallucis Muscle Strength
Timepoint
Before and After the Intervention
Method of measurement
Loadcell
2
Description
Volume of Abductor Hallucis Muscle
Timepoint
Before and After the Intervention
Method of measurement
MRI
3
Description
Cross Sectional Area of Abductor Hallucis Muscle
Timepoint
Before and After the Intervention
Method of measurement
MRI
4
Description
Intermetatarsal Angle
Timepoint
Before and After the Intervention
Method of measurement
MRI
5
Description
Range of Motion of First Metatarsophalangeal Joint
Timepoint
Before and After the Intervention
Method of measurement
Goniometer
6
Description
Disability
Timepoint
Before and After the Intervention
Method of measurement
FAAM Questionnaire
Intervention groups
1
Description
Intervention group: This group will use the newly designed orthosis with the capability of neuromuscular electrical stimulation for four weeks. Electrical stimulation will be performed based on the schedule for 3 weeks and three times a week. From the middle of the third week, with the gradual exclusion of electrical stimulation, therapeutic exercise will be performed until the end of the fourth week. This is a toe spread out exercise that has three phases and greatly contracts the abductor hallucis muscle. This exercise will be done twice a day for 15 minutes. Clinical evaluations and MRI will be performed before and after treatment. Then the combination of orthosis and exercise therapy will continue for only three months and clinical evaluations will be repeated at the end of 3 months.
Category
Rehabilitation
2
Description
Control group: This group will use the newly designed orthosis for four weeks without the capability of neuromuscular electrical stimulation. Therapeutic training will begin in the middle of the third week and will continue until the end of the fourth week. In this group also clinical evaluations and MRI will be performed before and after treatment. Then the combination of orthosis and exercise therapy will continue for only three months and clinical evaluations will be repeated at the end of 3 months.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran University of Medical Scienses, Faculty of Rehabilitation, Orthotic and Prosthetic Department
Full name of responsible person
Dr Maryam Jalali
Street address
Faculty of Rehabilitation Sciences, Madadkaran St., Shah Nazari St., Madar Square, Mirdamad Blvd., Tehran. Postal code: 1545913487
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 0947
Email
nasrin.mouloodi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research and Technology, Iran University of Medical Sciences
Street address
School of Rehabilitation Sciences, Madadkaran St., Shah Nazari St., Madar Square, Mirdamad Blvd., Tehran. Postal code: 1545913487
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 0947
Email
nasrin.mouloodi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Maryam Jalali
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Department of Orthotics and Prosthetics, School of Rehabilitation Sciences, Shah Nazari St, Madadkaran St, Mother Sq, Mirdamad Blv. Postal Code: 1545913487
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 0947
Email
marjalali@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Jalali
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Department of Orthotics and Prosthetics, School of Rehabilitation Sciences, Shah Nazari St, Madadkaran St, Mother Sq, Mirdamad Blv. Postal Code: 1545913487
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 0947
Email
marjalali@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Nasrin Moulodi
Position
PhD Candidate of Orthotics and Prosthetics
Latest degree
Master
Other areas of specialty/work
Others
Street address
Department of Orthotics and Prosthetics, School of Rehabilitation Sciences, Shah Nazari St, Madadkaran St, Mother Sq, Mirdamad Blv. Postal Code: 1545913487
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 0947
Email
nasrin.mouloodi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available