| 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
|
|
|
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
|
|
|
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.
|