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CTRI Number  CTRI/2024/10/074693 [Registered on: 03/10/2024] Trial Registered Prospectively
Last Modified On: 23/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Taping and Elastic band treatment in NCC Cadet with Heel Pain 
Scientific Title of Study   Combined Effects of Dynamic Taping and Moderate Intensity TheraBand training on Disability, Pain and over all well-being among NCC Cadets with Chronic Heel Pain- A Pilot Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Mohammad Sidiq 
Designation  ASSOCIATE PROFESSOR 
Affiliation  GALGOTIAS UNIVERSITY 
Address  Room No. B-317, Department of Physiotherapy, School of Allied Health Science, Galgotias University, Plot No 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida
NA
Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  6006204628  
Fax    
Email  sidufatima@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Samsudin Choudhary 
Designation  STUDENT 
Affiliation  GALGOTIAS UNIVERSITY 
Address  Room No. E004 Department of Physiotherapy, School of Allied Health Science, Galgotias University, Plot No 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida
NA
Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  7307880410  
Fax    
Email  samsudinchoudhary26@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Mohammad Sidiq 
Designation  Associate Proffesor 
Affiliation  GALGOTIAS UNIVERSITY 
Address  Room No. B317 Department of Physiotherapy, School of Allied Health Science, Galgotias University, Plot No 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida
NA
Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  6006204628  
Fax    
Email  sidufatima@gmail.com  
 
Source of Monetary or Material Support  
Research and Development Cell, Galgotias University, Plot No 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida, G.B Nagar, Uttar Pradesh, India -203201 
 
Primary Sponsor  
Name  GALGOTIAS UNIVERSITY 
Address  Plot No 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida, G.B Nagar, Uttar Pradesh, India -203201 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mohammad Sidiq  GALGOTIAS UNIVERSITY  Room No. B317 Department of Physiotherapy, School of Allied Health Science, Galgotias University, Plot No 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH 		 6006204628

sidufatima@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Departmental Research Committee, Galgotias University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dynamic Tape TheraBand  All patients will receive Dynamic tape application for heel pain and also moderate intensity TheraBand training at baseline (1st session). Follow up will be done for the patients on second visit at 1 week and after 4 weeks. Total number of sessions will be 4 for a duration of 4 weeks. All the patients will be explained about the possible benefits and complete procedure of the study and consent will be signed by each patient who is willing to participate in the study. They will be informed that it is voluntary and that they can withdraw anytime from the study without affecting their treatment if they refuse to be part of the study. Patient information will be kept confidential. Each individual will serve as self-control to report about the possible benefit in pain score after receiving Dynamic taping and TheraBand training. 
Comparator Agent  Therapeutic ultrasound Plantar fascia stretching   All patients in the control group will receive conventional physiotherapy treatment. It will include Therapeutic ultrasound Plantar fascia stretching. All the patients will be explained about the possible benefits and complete procedure of the study and consent will be signed by each patient who is willing to participate in the study. They will be informed that it is voluntary and that they can withdraw anytime from the study without affecting their treatment if they refuse to be part of the study. Patient information will be kept confidential. Each individual will serve as self-control to report about the possible benefit in pain score after receiving conventional physiotherapy and after follow up. Patient will receive 2 sessions for the duration of 4 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  26.00 Year(s)
Gender  Both 
Details  1.NCC Cadets with CHP more than 3 months duration.
2.Cadets with standing time more than 6 Hours more.
3.Both males and females will be included in the study.
4.Cadets exercising on hard surfaces or concrete.
 
 
ExclusionCriteria 
Details  1.Recent injuries or fractures.
2.Previous history of foot fracture or deformity.
3.Participants unwilling to sign informed consent.
4.Metabolic disease like Diabetes, Gout etc.
5.Rheumatic joint disease.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Foot Function Index
NPRS Score  		 At Baseline ,
2nd Week and 4 Weeks  
 
Secondary Outcome  
Outcome  TimePoints 
SF36  At Baseline,
2nd Week and 4 Weeks 
 
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   N/A 
Date of First Enrollment (India)   11/10/2024 
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 Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [samsudinchoudhary26@gmail.com].

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 02-01-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This pilot study explores the combined effects of dynamic taping and moderate-intensity TheraBand training on disability, pain, and overall well-being in NCC cadets suffering from chronic heel pain. Chronic heel pain, commonly experienced by individuals with an active lifestyle, can lead to reduced mobility, increased disability, and negatively impact overall well-being. The intervention integrates dynamic taping, known for its biomechanical support and pain relief properties, with TheraBand training, aimed at strengthening and improving functional mobility. The study evaluates the effects of this combined approach using disability indices, pain scales, and overall well-being assessments in a sample of NCC cadets. The results are expected to provide insights into whether this non-invasive, dual-modality approach can improve functional outcomes, reduce pain, and enhance the quality of life for those affected by chronic heel pain. This study could serve as a basis for larger clinical trials and future rehabilitation programs for similar conditions. 
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