| CTRI Number |
CTRI/2025/04/085754 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prevalence study |
| Study Design |
Other |
|
Public Title of Study
|
Restless Leg Syndrome among Physiotherapy Professionals |
|
Scientific Title of Study
|
Prevalence of Restless Leg Syndrome among physiotherapy professionals An observational 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 |
Dr Neha Mulla |
| Designation |
Assistance professor |
| Affiliation |
KAHER Institute of physiotherapy , Belgavi. |
| Address |
KAHER institute of physiotherapy, Belagavi.
Department of neuro physiotherapy Room No 23
KAHER institute of physiotherapy, Belagavi.
Department of neuro physiotherapy Room No 23
Belgaum
KARNATAKA
590010
India |
| Phone |
8660491303 |
| Fax |
|
| Email |
nehamulla@klekipt.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Vaishnavi Jadhav |
| Designation |
Intern |
| Affiliation |
KLE institute of physiotherapy, Belagavi. |
| Address |
KAHER Institute of physiotherapy, Belagavi.
Department of Neurophysiotherapy,Room no 13.
Belgaum
KARNATAKA
590010
India |
| Phone |
09096992615 |
| Fax |
|
| Email |
vaishjadhav2621@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
VAISHNAVI M JADHAV |
| Designation |
INTERN |
| Affiliation |
KLE institute of physiotherapy, Belagavi. |
| Address |
KAHER institute of physiotherapy, Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
09096992615 |
| Fax |
|
| Email |
vaishjadhav2621@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
KLE INSTITUTE OF PHYSIOTHERAPY,Physiotherapy opd no 29 neharu nagar belagavi. india 590010 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| VAISHNAVI |
HOSPITALS, PRIVATE CLINICS ALL OVER INDIA |
KLE INSTITUTE OF PHYSIOTHERAPY , BELAGAVI, KARANATALA.
Belgaum
KARNATAKA |
09096992615
vaishjadhav2621@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KAHER Ethical review board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Restless leg syndrome |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Physiotherapy professionals of all genders, who are willing to participate
Physiotherapy professionals who work in a hospital, clinics, academics or provide home based rehabilitation.
|
|
| ExclusionCriteria |
| Details |
Medications such as Benzodiazepines, Antidepressants, Protein pump inhibitors or NSAIDS |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| IRLS(international restless leg syndrome scale) |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="384"
Sample Size from India="384"
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)
|
09/05/2025 |
| 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 Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response (Others) -
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Ethical clearance will be obtained from institutional ethical committee of KAHER Institute of physiotherapy , Belagavi. Study will be registered under CTRI, After which the study will commence All Physiotherapists working in Private/ Government hospitals, clinicians, Physiotherapists providing home based services and academicians will be enrolled in the study. The purpose and need of the study will be explained to all participants; the confidentiality of the subject will be maintained and inform consent will be obtained from each participant and Inform Consent will be obtained from each participants after which they will be screened for inclusion and exclusion criteria prior to the enrolment into the study. Data will be collected through Google form, which contains demographic details of each study participants and which will contain 10 questions based on IRLS Scale which is our diagnostic tool to identify and classify severity of restless leg syndrome, the form will be forwarded via multimedia platform such as whatsApp and email, circulated through contacts and sampling would be convince sampling. IRLS will feature questions related to restless leg syndrome, work related stress, and hence this tool proves to be effective in understanding the causes of restless leg syndrome. Data will then be collected, tabulated and analysed using SPSS software |