| CTRI Number |
CTRI/2025/09/094551 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on How Sleep Issues Influence Recovery, Balance, and Quality of Life After Stroke |
|
Scientific Title of Study
|
Association of sleep disturbances on balance and cognition and quality of life in post stroke survivors. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivani Patil |
| Designation |
Post Graduate Student |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy |
| Address |
Department of Neurophysiotherapy,Dr. D. Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
7972278108 |
| Fax |
|
| Email |
patilshivani23032001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preeti Gazbare |
| Designation |
Professor |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy |
| Address |
Department of Neurophysiotherapy,Dr. D. Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9096116134 |
| Fax |
|
| Email |
preeti.gazbare@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Shivani Patil |
| Designation |
Post Graduate Student |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy |
| Address |
Department of Neurophysiotherapy,Dr. D. Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
7972278108 |
| Fax |
|
| Email |
patilshivani23032001@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Dr. D. Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018 |
|
|
Primary Sponsor
|
| Name |
Shivani Patil |
| Address |
Dr. D. Y. Patil College of Physiotherapy Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018 |
| Type of Sponsor |
Other [Self Funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shivani Patil |
Dr. D. Y. Patil College of Ayurved and Research Centre |
Physiotherapy OPD,Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
7972278108
patilshivani23032001@gmail.com |
| Dr Shivani Patil |
Dr. D. Y. Patil College of Physiotherapy OPD |
Out Patient Department,Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
7972278108
patilshivani23032001@gmail.com |
| Dr Shivani Patil |
Dr. D. Y. Patil Medical College, Hospital & Research Centre |
Physiotherapy Department,Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
7972278108
patilshivani23032001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I679||Cerebrovascular disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Individuals diagnosed with stroke by neurologist
2 Age 40 to 70 Years of individuals.
3 Individuals able to walk few steps with or without support.
4 Individuals able to follow commands.
5 Individuals fulfilling the criteria according to Diagnostic and statistical manual of mental disorders 5th edition of insomnia |
|
| ExclusionCriteria |
| Details |
Patients with significant pre-existing disabilities (e.g., severe motor impairments due to conditions other than stroke). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pittsburgh sleep quality index
Berg balance scale
Montreal cognitive assessment
SF12 |
Baseline Assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
22/09/2025 |
| 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 study titled “Association of Sleep Disturbances on Balance, Cognition, and Quality of Life in Post-Stroke Survivors” is an observational study conducted at Dr. D.Y. Patil Hospital and Research Center, Old Age Homes, local societies in Pimpri, and Dr. D.Y. Patil College of Physiotherapy, Pune. It aims to examine the impact of sleep disturbances, assessed using DSM-5 criteria, on balance, cognition, and quality of life among post-stroke survivors, as these deficits may hinder independence and slow rehabilitation. A total of 200 participants will be recruited through convenience sampling, with 100 in the observational group and 100 in the control group, the sample size calculated using Win Pepi version 11.65 at 95% confidence and 80% power. Outcome measures will include the Berg Balance Scale for balance, the Montreal Cognitive Assessment for cognition, and the SF-12 questionnaire for quality of life, thereby exploring whether improving sleep quality can enhance rehabilitation outcomes. |