| 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
|
|
|
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
|
|
|
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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