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CTRI Number  CTRI/2024/10/076034 [Registered on: 29/10/2024] Trial Registered Prospectively
Last Modified On: 26/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Cluster Randomized Trial 
Public Title of Study   Development and Validation of a Spine Exerciser Device to Enhance Spine Flexibility and Muscular Strength.  
Scientific Title of Study   A Spine Exerciser Device  
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 Krupali Gajera 
Designation  Post Graduate Student 
Affiliation  School of Physiotherapy,RK University 
Address  Kasturbadham, Rajkot-Bhavnagar Highway,Rajkot,Gujarat,India.

Rajkot
GUJARAT
360020
India 
Phone  9687670207  
Fax    
Email  kgajera071@rku.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Priyanshu Rathod 
Designation  Professor 
Affiliation  School of Physiotherapy,RK University 
Address  Kasturbadham, Rajkot-Bhavnagar Highway,Rajkot,Gujarat,India.

Rajkot
GUJARAT
360020
India 
Phone  9426803108  
Fax    
Email  priyanshu.rathod@rku.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Priyanshu Rathod 
Designation  Professor 
Affiliation  School of Physiotherapy,RK University 
Address  Kasturbadham, Rajkot-Bhavnagar Highway,Rajkot,Gujarat,India.

Rajkot
GUJARAT
360020
India 
Phone  9426803108  
Fax    
Email  priyanshu.rathod@rku.ac.in  
 
Source of Monetary or Material Support  
School of Physiotherapy,RK University,Rajkot-Bhavnagar highway, Rajkot,Gujarat , India. Pincode-360020 
 
Primary Sponsor  
Name  School of Physiotherapy 
Address  RK University, Kasturbadham, Rajkot-Bhavnagar highway, Rajkot,Gujarat,India Pincode -360020 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
Dr Krupali Gajera  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 Krupali Gajera  RK University   Room No-207,Research Department, School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar highway, Rajkot-360020, Gujarat, India
Rajkot
GUJARAT 		 9687670207

kgajera071@rku.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical Committee,School of Physiotheray,RK University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Oswestry Disability Index 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Exercises for Spinal flexor and extensor muscles- stretching and strengthening   Frequency: Single session Duration: 6 to 8 minutes, tailored to subject-specific training requirements. Note: This intervention is a one-time session aimed at testing the feasibility and safety of the innovative spinal exercise device. 
Comparator Agent  NA  Note : There is no controlled group.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Healthy individuals,
No Current Spinal Injuries or Severe musculoskeletal Disorders.
Able to provide informed Consent. 
 
ExclusionCriteria 
Details  Patient with history of spinal injury in last one year,
pregnant women
Conditions that can contraindicate Physical exercise. 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Spinal joint Range of motion.  Two time points : Before and after the perfromaing exercsies  
 
Secondary Outcome  
Outcome  TimePoints 
Strength of Spinal muscles :Rectus Abdominis,Transverse Abdominis.  Pre and post to perfromaing exercsies on Spinal Exercseiring devcie  
Safety and feasibility of Device.  Two time points :
Safety - before performing exercise on device .
Feasibility - during the use of the device for performing exercises. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   14/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  14/11/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="4"
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 - NO
Brief Summary  
TITLE : Development and Validation of a Spine Exerciser Device to Enhance Spinal Flexibility and Muscular Strength.

INVESTIGATOR : Dr Krupali Gajera ,School of Physiotherapy,RK University, Dr. Priyanshu Rathod, Professor,School of Physiotherapy.RK University.

Aim:The primary aim of this project is to design and develop a Spine Exerciser Device that provides a comprehensive solution for enhancing spinal health by targeting spinal muscles through strengthening and stretching exercises.

Objectives:
 -Design and develop a user-friendly Spine Exerciser Device that strengthens and stretches spinal muscles, improving flexibility and reducing injury risk, while ensuring accessibility for individuals of all fitness levels.
- Conduct thorough testing and evaluation to guarantee safety, effectiveness, and user satisfaction, and provide clear instructions and guidelines for proper use and maintenance.
- Explore partnerships with public fitness facilities to integrate the device into their equipment offerings, ensuring seamless adoption and promoting comprehensive spinal conditioning for a broader audience.

Material

 

Device Components: 

-  High-quality steel frame for durability.

-  Ergonomic foam padding for user comfort.

-  Adjustable bars with non-slip grips.

-  High-tension springs for resistance.

-  Safety locks to secure the device during use. 


Phase 1: Need Analysis for developing A SPINE EXERCISER DEVICE by clinical rationale. systematic review and focus group discussion.

Literature Review and Systematic Review: A comprehensive literature review reveals that while numerous studies from search engines like PubMed and Google patent assess the effectiveness of various spine exercisers in clinical and community settings, gaps exist in addressing the simultaneous requirements for both strengthening and stretching spinal muscles with existing devices.

Focus Group Discussions: Discuss preferences and expectations regarding features, usability, safety considerations, and accessibility of the Spine Exerciser Device in public fitness facilities.

Clinical Rationale Development: Based on literature findings and focus group insights, a Spine Exerciser Device is justified to meet the critical need for simultaneously strengthening and stretching spinal muscles, thereby potentially reducing injury risks, enhancing posture, and improving overall spinal health, complementing traditional exercise routines and filling gaps in existing public fitness equipment. 

Phase 2: Prototype Device Development 

 Design:

Collaborate with engineers and designers to translate refined concepts into detailed engineering drawings and specifications. Determine materials, components, and manufacturing processes suitable for producing prototypes of the Spine Exerciser Device.

Phase 3: Efficacy Testing  

Study Design:

Determine study parameters such as sample size, participant demographics (e.g., consent, age, fitness level), and duration of the study.

Consider ethical considerations and obtain necessary approvals from relevant institutional review boards (IRBs) or ethics committees.

Sampling Technique:

Convenience sampling for initial prototype testing.

Stratified random sampling for public testing to ensure diverse participant representation.

 

Outcome measures:

Spinal joint Range of Motion with Goniometer and Spinal Strength with the  increased number of Curl-ups.


Selection Criteria: 

Inclusion Criteria:

 - Adults aged 18-65 years.

 - No current spinal injuries or severe musculoskeletal disorders.

 - Able to provide informed consent.

 Exclusion Criteria:

 - History of spinal surgery in last one year.

 - Pregnancy. 

 - Any condition that would contraindicate physical exercise. 


Procedure:

-  Participants will use the device and perform both trunk flexion and extension by curl-ups and spinal stretches.

-  Each session will last 5 minutes and immediate effect will be measured by taking range of motion and number of repetition of curl ups for the spinal strength.

 

- Pre- and post-intervention assessments will measure spinal muscle strength, flexibility, and user satisfaction immediately after performing exercises on device.

Data will be analyzed to assess improvements in spinal health and overall effectiveness of the device. 
 
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