| CTRI Number |
CTRI/2024/03/064145 [Registered on: 14/03/2024] Trial Registered Prospectively |
| Last Modified On: |
14/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [orthosis] |
| Study Design |
Other |
|
Public Title of Study
|
Designing and testing of modified flexible bunion splint with arch support for great toe deformity |
|
Scientific Title of Study
|
Design and Evaluation of Modified Dynamic Hallux Valgus Splint Incorporating Arch Support for Mild to Moderate Hallux Valgus Deformity on Hallux Valgus Angle, Balance and Foot Function |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rukhsana |
| Designation |
final year student, Master of Prosthetics and Orthotics |
| Affiliation |
Indian Spinal Injury Centre, Institute of Rehabilitation Sciences |
| Address |
department of prosthetics and orthotics, basement,Indian Spinal Injuries Centre, Sector C, Vasant Kunj,
Opp. Vasant Valley School,
New Delhi - 110070
New Delhi
DELHI
110070
India |
| Phone |
919891558452 |
| Fax |
|
| Email |
rukhsanasiddique029@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shivangi Mehra |
| Designation |
Assistant Professor, Prosthetics and Orthotics |
| Affiliation |
Guru Gobind Singh Indraprastha University |
| Address |
Indian Spinal Injuries Centre, Sector C, Vasant Kunj, New Delhi 110070
Guru Gobind Singh Indraprastha University, Sector - 16C, Dwarka, New Delhi - 110078 (India)
New Delhi
DELHI
110070
India |
| Phone |
7503271591 |
| Fax |
|
| Email |
shivangimehraisic@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rukhsana |
| Designation |
final year student, Master of Prosthetics and Orthotics |
| Affiliation |
Indian Spinal Injury Centre, Institute of Rehabilitation Sciences |
| Address |
department of prosthetics and orthotics, basement, Indian Spinal Injuries Centre, Sector C, Vasant Kunj,
Opp. Vasant Valley School,
New Delhi - 110070
Indian Spinal Injuries Centre, Sector C, Vasant Kunj,
Opp. Vasant Valley School,
New Delhi - 110070
New Delhi
DELHI
110070
India |
| Phone |
919891558452 |
| Fax |
|
| Email |
rukhsanasiddique029@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Spinal Injuries Centre, sector C Vasant Kunj, New Delhi-110070, India |
|
|
Primary Sponsor
|
| Name |
Rukhsana |
| Address |
Indian Spinal Injury Centre-Institute of Rehabilitation Sciences, Sector C, Vasant Kunj, New Delhi 110070 |
| Type of Sponsor |
Other [self financing] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shivangi Mehra |
Indian Spinal Injuries Centre |
Sector C, Vasant Kunj,
Opp. Vasant Valley School,
New Delhi - 110070
Guru Gobind Singh Indraprastha University (GGSIPU), Sector - 16C, Dwarka, New Delhi - 110078 (India)
New Delhi
DELHI |
07503271591
shivangimehraisic@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| indian spinal injury centre institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
hallux valgus deformity |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
modified dynamic Hallux Valgus Splint incorporating arch
4 week intervention will be provided to the patient after the fitment of the splint |
It is a modified dynamic hallux valgus splint which is made up of low temperature thermoplastic sheet (orphid) hold the hallux (greater toe) in adduction position through the distal part of the splint and provide the flexion/extension movement of the first metatarsophalangeal (MTP) joint through the dynamic joint provided in between the proximal and distal component of the splint along with this it also incorporates the arch support mechanism in the plantar aspect of the splint which reduces the plantar pressure beneath the first MTP joint and also redistribute uneven pressure over the plantar aspect of the foot.
4 week intervention will be provided to the patient after the fitment of the splint |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Mild to moderate hallux valgus
Flexible hallux valgus
Hallux valgus angle ranging from 15-35â—¦ as per Manchester scale
Age: 19-45 years
Sufficient education to complete a questionnaire independently
Commitment to wear wide toe box footwear |
|
| ExclusionCriteria |
| Details |
Severe hallux valgus
Disease impacting foot condition such as diabetes, gout, leprosy
Dislocations or fractures of metatarsophalangeal joints
Hindfoot deformities
Cognitive or psychological problems that could influence the study i.e. neurological
deficits
Any surgical history of foot
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| hallux valgus angle by evaluating through goniometer of the participant |
before and after 4 week intervention with modified dynamic hallux valgus splint incorporating arch support |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| static balance, dynamic balance, foot function |
after 4 week intervention after providing modified dynamic hallux splint incorporating arch support |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Hallux valgus is a complex progressive deformity affecting the forefoot in which lateral
deviation of the great toe is the most obvious feature. It is associated with a bunion, i.e.,
the prominent first metatarsal medial eminence and overlying chronically inflamed
adventitious bursa. The deformity comprises medial deviation of the first metatarsal, giving
rise to a widened forefoot and lateral deviation with or without pronation of the hallux. The
prevalence is up to 23% in age 18–65-year-old and >35% in older than 65 years. The
etiology of HV is not completely understood and appears to be multifactorial. Different
conservative treatment options have been proposed for first-line treatment, including
different kinds of orthoses, splints and manual therapy. Orthoses have been proposed to
reduce the elevated plantar pressure under the medial ray in patients with HV and reduce
pain. The previous studies suggest that a foot orthoses with medial arch support
mechanism is efficient for relieving and redistributing the plantar pressure on the first
metatarsophalangeal joint but studies have not incorporated both the mechanisms of arch
support as well as toe alignment to evaluate its effect on hallux valgus. So, the aim of this
study is to design and investigate the effect of modified dynamic hallux valgus splint
incorporating arch support on Hallux valgus angle, balance (static and dynamic) and foot
function. Procedure will start from analyzing the requirement and modifying dynamic
hallux valgus splint by incorporating the arch support mechanism in it. Designing and
fabrication of the splint will be done. Prototype of hallux valgus splint incorporating arch
support mechanism will be ready for testing and clinical trial. The prototype trail would be
done on patient under the supervision of the guide in a clinical setup. Rectification of the
splint will be done by analyzing the practical demonstration and trial provided to the patient
in the clinical setup. After several rectification and modification, prototype will be ready
for the evaluation the effectiveness of dynamic HV splint incorporating arch support
mechanism to be tested on various parameters including HV angle, balance (static and
dynamic) and foot function. Place of the research will be Indian spinal injury center, Vasant
Kunj, New Delhi. Risks and discomforts associated with the study are minimum to low.
Sampling will be done using non probability convenient sampling method. Subjects
diagnosed with hallux valgus will be recruited according to the inclusion criteria by
convenient sampling. The data of the subjects who are willing to participate in the study
will be collected after taking consent. Pre-test data of HV angle, static balance, dynamic
balance and foot function will be collected using goniometer, single leg stance test, star
excursion balance test and foot function respectively. Intervention of modified hallux
valgus splint incorporating arch support will be provided to the patient for four weeks.
Follow-up will be taken after every week. After the completion of four-week intervention
period post test data of HV angle, balance (static and dynamic) and foot function will be
collected. The collected data will be analyzed using SPSS (Statistical package for the social
science software). |