| CTRI Number |
CTRI/2024/07/070637 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
14/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Checking Balance After Neck Surgery |
|
Scientific Title of Study
|
Asssessing balance in various sensory conditions post degenerative cervical spine surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sukanya |
| Designation |
Postgraduate student |
| Affiliation |
SDM college of physiotherapy |
| Address |
Neurophysiotherapy opd room no 5,Manjushree building, SDM college of physiotherapy, SDM college of medical sciences and hospital manjushree nagar sattur, dharwad ,karnataka 580009, India
Dharwad
KARNATAKA
580009
India |
| Phone |
6363560847 |
| Fax |
|
| Email |
smudale02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sukanya |
| Designation |
Postgraduate student |
| Affiliation |
SDM college of physiotherapy |
| Address |
Neurophysiotherapy opd room no 5,Manjushree building, SDM college of physiotherapy, SDM college of medical sciences and hospital manjushree nagar sattur, dharwad ,karnataka 580009, India
KARNATAKA
580009
India |
| Phone |
6363560847 |
| Fax |
|
| Email |
smudale02@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharmila D |
| Designation |
Professor |
| Affiliation |
SDM college of physiotherapy |
| Address |
Neurophysiotherapy opd room no 5,Manjushree building, SDM college of physiotherapy, SDM college of medical sciences and hospital manjushree nagar sattur, dharwad ,karnataka 580009, India
Dharwad
KARNATAKA
580009
India |
| Phone |
9880950990 |
| Fax |
|
| Email |
sharmila.dudhani@sdmuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| SDM college of physiotherapy Manjushree Nagar Sattur Dharwad-580009, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Sukanya |
| Address |
SDM college of medical sciences and hospital, SDM college of physiotherapy manjushree nagar sattur Dharwad-580009, Karnataka, India |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Sukanya |
Shri Dharmasthala Manjunatheshwara |
Neurophysiotherapy opd room no 5,Manjushree building, SDM college of physiotherapy, SDM college of medical sciences and hospital manjushree nagar sattur, dharwad ,karnataka 580009, India
Dharwad
KARNATAKA |
6363560847
smudale02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM College of Medical Sciences And Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M479||Spondylosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who are in the first month of post
operative duration following cervical spine surgery
due to degenerative disorders.
2.Any gender
3.Age 35 -65 years |
|
| ExclusionCriteria |
| Details |
1. Patients unable to stand due to any reason
2.Traumatic neck injury
3.Vestibular disease such as benign paroxysmal
positional vertigo (BPPV)
4. Meniere’s Disease
5. Any Neurological condition that can affect
balance- example – diabetic neuropathy, stroke etc
6. Patients with Visual impairment
7. Musculoskeletal diseases that may cause inability
to stand on balance board |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Modified clinical test for sensory interaction on
balance (mCTSIB) on (BTracks) machine Path length(cm), Horizontal bar(indicates percentile ranking), COP path (Anterior-Posterior and Medio-Lateral measured in cm) , Angle metrics measured in degree. |
One time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
28/07/2024 |
| 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="0"
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 - NO
|
|
Brief Summary
|
It is expected that the patients who have been operated for degenerative cervical spine surgery will have balance issues in various sensory conditions in the first month, hence the patients in this phase need to be addressed for the same. Patients who have undergone cervical spine surgery due to degenerative disorder will be taken from SDM hospital. Those who fulfill the inclusion criteria will be requested to participate in the study. A written consent will be obtained by the participants and at the same time an information leaflet about the details of the study will be shared. Study procedure will be explained to the participants. Participants will be evaluated on modified CTSIB (BTracks) in 4 different sensory conditions . Eyes open -firm surface Eyes closed -firm surface Eyes open-foam Eyes closed -foam Postural sway for each condition will be determined by path length in centimeters displayed on the screen, Path length(cm), Horizontal bar (indicates percentile ranking), COP path (Anterior- Posterior and Medio-Lateral measured in cm) , Angle metrics measured in degree.
|