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CTRI Number  CTRI/2025/07/091906 [Registered on: 28/07/2025] Trial Registered Prospectively
Last Modified On: 25/07/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study to check how Sleep Affects Disability and Daily Functioning in patients of Spinal Cord Injury 
Scientific Title of Study   Effect of Sleep Quality on Disability and Functional Impairment among individuals with Chronic Spinal Cord Injury: A Prospective Cross-Sectional 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  SATYASHEEL SINGH ASTHANA 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Raebareli 
Address  Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Madhupuri, Uttar Pradesh 229405.

Rae Bareli
UTTAR PRADESH
229405
India 
Phone  9169385726  
Fax    
Email  satyapmr2015@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  SATYASHEEL SINGH ASTHANA 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Raebareli 
Address  Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Madhupuri, Uttar Pradesh 229405.

Rae Bareli
UTTAR PRADESH
229405
India 
Phone  9169385726  
Fax    
Email  satyapmr2015@gmail.com  
 
Details of Contact Person
Public Query
 
Name  SATYASHEEL SINGH ASTHANA 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Raebareli 
Address  Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Madhupuri, Uttar Pradesh 229405.

Rae Bareli
UTTAR PRADESH
229405
India 
Phone  9169385726  
Fax    
Email  satyapmr2015@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Madhupuri, Uttar Pradesh 229405, India 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, Raebareli, Uttar Pradesh 
Address  All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Madhupuri, Uttar Pradesh 229405 
Type of Sponsor  Government medical college 
 
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 Satyasheel Singh Asthana  All India Institute of Medical Sciences, Raebareli  Room 28, Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Raebareli, Munshiganj, Madhupuri, Raebareli, Uttar Pradesh 229405
Rae Bareli
UTTAR PRADESH 
9169385726

satyapmr2015@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC), AIIMS Raebareli, Uttar Pradesh, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G822||Paraplegia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Must be a patient of chronic spinal cord injury irrespective of cause, time since injury should be more than six months. Age of patient must be more than 18 years. 
 
ExclusionCriteria 
Details  Patient on a rehabilitation protocol from any other place or institute. Patients who do not want to take part in study. Pregnant females. Severe cognitive impairments, patients unable to comprehend or fill out questionnaires. History of psychiatric disorders unrelated to SCI. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pittsburgh Sleep Quality Index (PSQI)
World Health Organization Disability Assessment Schedule (WHODAS 2.0 – 12 item Questionnaire
Functional Independence Measure 
One time through questionnaire since it is a cross sectional study 
 
Secondary Outcome  
Outcome  TimePoints 
Patient Health Questionnaire-9 (PHQ-9)
Numerical Pain rating Scale (NPRS) 
One time through questionnaire since it is a cross sectional study 
 
Target Sample Size   Total Sample Size="91"
Sample Size from India="91" 
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)   07/08/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Spinal cord injury (SCI) is a life-altering condition that leads to varying degrees of paralysis and disability, depending on the level and extent of the injury. Sleep disturbances are common in people with SCI due to a variety of factors including pain, spasticity, medication side effects, neurogenic bladder, and respiratory complications. Existing evidence suggests that poor sleep quality is associated with a wide range of negative outcomes, including increased pain perception, fatigue, mood disorders, and cognitive impairments. However, there is a lack of comprehensive research directly linking sleep quality with the specific dimensions of disability and functional limitations in individuals with chronic SCI.

The functional capacity and independence of individuals with chronic SCI are heavily influenced by various factors, including physical limitations, psychological well-being, and sleep quality. However, while much is known about the physiological impacts of SCI, there is a scarcity in studies that have explored how sleep affects both disability (the limitations imposed by the injury) and functional outcomes (the ability to perform activities of daily living, including mobility, self-care, and employment).

Sleep quality has been shown to affect cognitive functioning, physical endurance, mood, and pain levels—each of which plays a significant role in the ability of SCI individuals to perform daily tasks and participate in social and occupational activities. Poor sleep may exacerbate disability by increasing fatigue, reducing energy levels, and affecting mood regulation, all of which can contribute to functional limitations.

This study aims investigate the extent to which sleep quality impacts both disability and functional limitations in individuals with chronic SCI. By understanding these relationships, a better tailored individualized rehabilitation programs that address sleep disturbances as a modifiable factor can be made that may potentially improve the overall quality of life for individuals living with chronic SCI.

Methodology

Type of study: Prospective Cross-sectional Study.

Duration of Study: 2 years

Study Population: Patients of Chronic Spinal Cord Injury

Sample Size- For the purpose of sample size estimation, Avluk et al study was used. It was calculated using Online Openapi sample size calculator. To estimate the desired outcome in this study, significant with 95% confidence interval and power of 80%, the required minimum sample size will be 82 patients. Taking 10% non-valid responses, total sample size will be 91 patients of chronic spinal cord injury.

Inclusion Criteria: Must be a patient of chronic spinal cord injury irrespective of cause (time since injury > 6month). Age of patient must be more than 18 years.

Exclusion Criteria: Patient on a rehabilitation protocol from any other place or institute. Patients who do not want to take part in study. Pregnant females. Severe cognitive impairments (patients unable to comprehend or fill out questionnaires). History of psychiatric disorders unrelated to SCI (e.g., schizophrenia, bipolar disorder).

Sampling Technique: Consecutive sampling will be employed to select study participants from patients attending the Outpatient Department (OPD) of a tertiary care hospital. Individuals meeting the inclusion and exclusion criteria will be finally enrolled in the study after providing informed written consent.

Study Plan: Patient will be recruited from department of Physical Medicine and Rehabilitation OPD/IPD. Study will be started only after getting approval from Institutional Ethical Committee. Patients will be evaluated for inclusion and exclusion criteria. Written and informed consent will be taken from all participants. All the data will be recorded in working proforma Patients will be evaluated using 4 Scales/questionnaires: Pittsburgh Sleep Quality Index (PSQI) Hindi Version; World Health Organization Disability Assessment Schedule (WHODAS 2.0 – 12 item Questionnaire); Functional Independence Measure (FIM), Patient Health Questionnaire-9 (PHQ-9), Pain (if any) will be assessed using Numeric Pain Rating Scale (NPRS).

Statistical Analysis

Descriptive statistics will be used to summarize the demographic and clinical characteristics of the study participants. The following analyses will be performed. Correlation Analysis: Pearson or Spearman correlation tests (depending on data distribution) will be used to examine the relationship between sleep quality (PSQI), WHODAS 2.0 12 item scale and FIM. Group Comparisons: Chi-Square test will be used to compare sleep quality between Groups based on Gender; Poor or Good Sleep Quality; Pain Levels Regression Analysis: Multiple linear regression will be used to determine the independent effects of pain, disability (WHODAS 2.0), and functional independence (FIM) on sleep quality (PSQI), adjusting for potential confounders such as age, injury level, and comorbidities. A p-value of <0.05 will be considered statistically significant. SPSS version 29 will be used for the statistical analysis.

 

 

 
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