| CTRI Number |
CTRI/2024/09/074051 [Registered on: 19/09/2024] Trial Registered Prospectively |
| Last Modified On: |
12/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Design Development and Testing of an Innovative Device to Train Foot Muscles and Improve Foot Function |
|
Scientific Title of Study
|
Design and Development of the Footpro Rehabilitator A Comprehensive Study on Feasibility and Effectiveness in Foot Rehabilitation
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Solanki kinjal Govindbhai |
| Designation |
Post Graduate Student |
| Affiliation |
School of Physiotherapy, RK University |
| Address |
Research Department, Room no.207, School of Physiotherapy, RK University, Kasturbadham,
Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India.
Rajkot
GUJARAT
360020
India |
| Phone |
6353868169 |
| Fax |
|
| Email |
ksolanki252@rku.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Sharma |
| Designation |
Director, School of Physiotherapy, RK University |
| Affiliation |
School of Physiotherapy, RK University |
| Address |
School of Physiotherapy, RK University, Kasturbadham,
Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India.
Rajkot
GUJARAT
360020
India |
| Phone |
9811281520 |
| Fax |
|
| Email |
amit.sharma@rku.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Solanki kinjal Govindbhai |
| Designation |
Post Graduate Student |
| Affiliation |
School of Physiotherapy, RK University |
| Address |
Research Department, Room no.207, School of Physiotherapy, RK University, Kasturbadham,
Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India.
Rajkot
GUJARAT
360020
India |
| Phone |
6353868169 |
| Fax |
|
| Email |
ksolanki252@rku.ac.in |
|
|
Source of Monetary or Material Support
|
| Solanki Kinjal Govindbhai School of Physiotherapy, RK University, kasturbadham, Rajkot-Bhavnagar Highway, Rajkot, Gujarat, 360020, India. |
|
|
Primary Sponsor
|
| Name |
Solanki Kinjal Govindbhai |
| Address |
School of Physiotherapy, RK University, Kasturbadham , Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India |
| Type of Sponsor |
Other [[Self]] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| School of Physiotherapy RK University |
School of Physiotherapy, RK University, Kasturbadham , Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kinjal Solanki PT |
RK Physiotherapy Rehabilitation and Research Center |
Physiotherapy
Department, Room no.
1, opp Meghani rang
bhuvan, Bhaktinagar
circle Rajkot, Gujarat,
India
Rajkot
GUJARAT |
06353868169
ksolanki252@rku.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, School of Physiotherapy, RK University, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Footpro Rehabilitator Device |
This device used to train foot muscle. training will be given 5 days per week for 2 weeks. exercise given in this device is calf stretching, planter fascia stretching, isolate intrinsic-extrinsic muscle strengthening, ankle inversion- eversion with loop band(strengthening), toe curling, toe-spread-out, short foot exercise, marble pickup, towel curls, toe abduction-adduction. exercise will be tailored according to patients
specific needs. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
(1) Individual with heel pain |
|
| ExclusionCriteria |
| Details |
(1) A patients with recent foot infection, or open wound or fracture
(2) Cognitive impairments
(3) Not willing to sign informed consent |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ankle Joint Active Rang of Motion, VAS Scale, QUEST 2.0 Scale |
Pre Outcome at Baseline (first day of training)
Post Outcome after 2 week (last day of training) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Functional Scale: FFI(Foot Functional Index) |
Pre Outcome at Baseline (first day of training)
Post Outcome after 2 week (last day of training) |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
02/12/2024 |
| 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="3"
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
|
Title: DESIGN AND DEVLOPMENT OF THE FOOTPRO REHABILITATOR: A COMPREHENSIVE STUDY ONFEASIBILITY ANDEFFECTIVENESS IN FOOT REGABILITATION
Investigator: Kinjal Solanki; PT, Dr. Amit Sharma; MPT, PhD Scholar, School of Physiotherapy, RK University.
Background: Heel pain, affecting about 10% of the general population and frequently seen in runners, often involves conditions such as Planter Fasciitis, foot Tendinopathy, Calcaneal Apophysitis, Heel Spur. Risk factors such as poor muscle flexibility, heavy lifting, obesity, and excessive foot pronation contribute to its development. It poses hindrance in day-to-day activities and is becoming more common due to decrease in physical activities in modern day life.
Conservative treatments, such as stretching and strengthening exercise, release therapy, ice therapy, and activity modifications are typically effective and preferred over surgical options due to their lower risk and greater efficacy. This clinical trial aim to assess the feasibility and effectiveness of Footpro Rehabilitator, an integrated device designed to treat heel pain by combining multiple therapies into a single, cost-effective solution.
Method: Following ethical approval, 30 subjects will be selected as per inclusion and exclusion criteria and will receive exercise training with Footpro Rehabilitator Device. Outcome measures will be assessed before treatment (Baseline) with VAS Scale, ankle joint active range of motion (ROM) and functional scale: foot functional index (FFI). post-treatment assessment will be taken with the same outcome measures after 2 weeks.
The study is divided into three phases: Phase 1: Designing Footpro Rehabilitator as an integrated device for treating heel pain. Phase 2: Developing Footpro Rehabilitator as an integrated device for treating heel pain. Phase 3: Determine feasibility and effectiveness of Footpro Rehabilitator in treating heel pain. |