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CTRI Number  CTRI/2025/02/080122 [Registered on: 07/02/2025] Trial Registered Prospectively
Last Modified On: 29/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Relation between VO2 MAX, Sleep Quality And Wheelchair skills in SCI individuals who use manual wheelchair 
Scientific Title of Study   Correlation Between Submaximal Aerobic Capacity, Sleep Quality And Wheelchair Skills In SCI Individuals Maneuvering Manual Wheelchair. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
ISIC/RP/2024/031  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shagun Thakur 
Designation  PG Student 
Affiliation  Indian Spinal Injuries Center- Institute Of Rehabilitation Sciences 
Address  ISIC Institute of Rehabilitation Sciences, opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi, Delhi

South
DELHI
110070
India 
Phone  9318331646  
Fax    
Email  thakurshagun28971@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shagun Thakur 
Designation  PG Student 
Affiliation  Indian Spinal Injuries Center- Institute Of Rehabilitation Sciences 
Address  ISIC Institute of Rehabilitation Sciences, opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi, Delhi

South
DELHI
110070
India 
Phone  9318331646  
Fax    
Email  thakurshagun28971@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rimsha Siddiqui 
Designation  Associate Proffesor 
Affiliation  Indian Spinal Injuries Center- Institute Of Rehabilitation Sciences 
Address  ISIC Institute of Rehabilitation Sciences, opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi, Delhi

South
DELHI
110070
India 
Phone  9911288516  
Fax    
Email  rimshasiddiqui46@gmail.com  
 
Source of Monetary or Material Support  
ISIC Institute of Rehabilitation Sciences, opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi, Delhi 110070 
 
Primary Sponsor  
Name  Shagun Thakur 
Address  Indian Spinal Injuries Center- Institute Of Rehabilitation Sciences, IAA Colony, Sector C, Vasant Kunj, New Delhi, Delhi 110070 
Type of Sponsor  Other [Self] 
 
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 Rimsha Siddiqui  Indian Spinal Injuries Center  Rehabilitation Department, Opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi, Delhi 110070
South
DELHI 
9911288516

rimashasiddiqui46@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ISIC Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S242||Injury of nerve root of thoracic spine,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Correlation Study   A correlational study is a scientific method that observes the relationship between variables that occur naturally, without the researcher manipulating them. The goal of a correlational study is to determine if there is a relationship between variables, and the strength and direction of that relationship 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subject must had SCI for more than 6 months of duration.
Subject should use a manual hand-rim wheel chair for more than 50% of daily propulsion.
Subjects having SCI injury below T1 level.

 
 
ExclusionCriteria 
Details  Subject having a self-reported history of unstable angina or myocardial infarction within the previous month.
Subjects who were unable to comprehend or provide consent.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
VO2 MAX

 
In a long hallway with a smooth, tiled surface, two cones were positioned 32.1 m apart from each other. The participant was positioned next to one cone facing the second cone. The participant was instructed to propel themselves as rapidly as they could to the second cone, circle it, and return to the first, repeating the process as many times as they can within the trial’s 6-minute time frame. it will be measured at baseline
 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil
 
 
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)   25/02/2025 
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 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  
The Wheelchair Skills Test (WST) evaluates 33 individual skills on capacity, confidence, performance, and whether each is a training goal. For each skill, the user rates their ability on a scale of 0 to 3. Total scores are calculated for capacity, confidence, and performance by summing individual scores and converting to a percentage. The questionnaire is intended to identify training needs and measure improvements in wheelchair skills over time. Six Minute Push Test (6MPT) is a standard clinical protocol that is widely recognized in assessing physical and cardiovascular fitness for Manual Wheelchair Users (MWUs). It is typically performed as a single 6-minute trial per participant and considered sufficient for assessing physical fitness. In a long hallway with a smooth, tiled surface, two cones were positioned 32.1 m apart from each other. The participant was positioned next to one cone facing the second cone. The participant was instructed to propel themselves as rapidly as they could to the second cone, circle it, and return to the first, repeating the process as many times as they can within the trial’s 6-minute time frame. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.



 
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