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CTRI Number  CTRI/2025/05/087820 [Registered on: 28/05/2025] Trial Registered Prospectively
Last Modified On: 27/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study to find the link between sleep quality, exercise quality, and daily activities in patients with spinal cord injury 
Scientific Title of Study   The Association Between Sleep Quality, Exercise Adherence, And Functional Independence In Individuals With Spinal Cord Injury. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Naveen 
Designation  Postgraduate in physiotherapy neuro science  
Affiliation  kasturba medical college 
Address  2nd floor, department of physiotherapy, Kasturba medical college hospital, nandiguda road, attavar, Mangalore.

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9003788091  
Fax    
Email  naveenmajstro2@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  dr vijayakumar k 
Designation  Addl.professor & HOD 
Affiliation  kasturba medical college 
Address  2nd floor, department of physiotherapy, Kasturba medical college hospital, nandiguda road, attavar, mangaluru.

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9980189597  
Fax    
Email  vijay.kk@manipal.edu  
 
Details of Contact Person
Public Query  
Name  dr vijayakumar k 
Designation  Addl.professor & HOD 
Affiliation  kasturba medical college 
Address  2nd floor, department of physiotherapy, Kasturba medical college hospital, nandiguda road, attavar, mangaluru.

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9980189597  
Fax    
Email  vijay.kk@manipal.edu  
 
Source of Monetary or Material Support  
kasturba medical college, nandigudda road,attavar,mangaluru,india,575002 
 
Primary Sponsor  
Name  naveen 
Address  2nd, floor department of physiotherapy , kastruba medical college hospital,nandigudda road,attavar,mangaluru,india,575002 
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 
DrNaveen  Kasturba Medical College Hospital  Physiotherapy department,2 floor,Kasturba Medical College Hospital,Nandiguda road,Attavar,Mangalore
Dakshina Kannada
KARNATAKA 		 9003788091

Naveenmajstro2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional Ethics Committee Kasturba medical College, Manglore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G959||Disease of spinal cord, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1)Subject diagnosed with spinal cord injury age between 18 to 65.
2)Patient with traumatic and non-traumatic injury SCI.
3)Patients from T6 to S2 level injury and above T6 level without any cardiac issues.
 
 
ExclusionCriteria 
Details  1)patient with multiple injuries like spinal cord injury with TBI, fracture in ribcage, and abdominal injuries.
2)Patients who are not oriented, unconscious, and uncooperative with very low psychological status.
3)Had severe chronic conditions, such as advanced respiratory or cardiovascular diseases.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)Pittsburgh Sleep Quality Index.
2) Withings sleep analyser
 		 1)15 days
2)7days 
 
Secondary Outcome  
Outcome  TimePoints 
exercise adherence rating scale  15days 
Spinal cord independence measure 3   on 1st day and day of discharge 
The Epworth sleepiness scale   15 days 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
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)   07/06/2025 
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="1"
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 - NO
Brief Summary  

The Research Explores The Association Between Sleep Quality, Exercise Adherence, And Functional Independence In Individuals With Spinal Cord Injury. SCI Disrupts Brain-Body Communication, Leading To Complications Like Sleep Disturbances, Pain, And Mobility Issues, Which Impact Daily Functioning. The Study Highlights How Sleep Quality Influences Exercise Participation And Functional Recovery, Emphasizing The Role Of Rehabilitation. Various Assessment Tools, Including The Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), Exercise Adherence Rating Scale (EARS), And Spinal Cord Independence Measure (SCIM 3.0), Are Used To Evaluate Participants. The Study Aims To Address Gaps In Existing Research By Using Both Subjective And Objective Measures, Such As Withing’s Sleep Monitors, To Assess Sleep Quality And Its Impact On Rehabilitation Outcomes. Findings May Help Improve Targeted Rehabilitation Programs, Enhancing The Quality Of Life For Individuals With Spinal Cord Injury.

 
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