| CTRI Number |
CTRI/2020/10/028589 [Registered on: 23/10/2020] Trial Registered Prospectively |
| Last Modified On: |
20/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
“Examining locomotory Parameters, Centre of Pressure and pelvic movements while dual –tasking in diabetic peripheral neuropathy |
|
Scientific Title of Study
|
“Analysis of Temporal Gait Parameters, Centre of Pressure and pelvic movements while dual –tasking in diabetic peripheral neuropathy: A cross-sectional study†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sneha Sudheer |
| Designation |
Post Graduate |
| Affiliation |
Ramaiah Medical college |
| Address |
Ramaiah Medical College,
Department of Physiotherapy,
M S Ramaiah Nagar,
MSRIT POST,
Bangalore, 560054
Ramaiah Medical College,
Department of Physiotherapy,
M S Ramaiah Nagar,
MSRIT POST,
Bangalore, 560054
Bangalore
KARNATAKA
560054
India |
| Phone |
09916695072 |
| Fax |
|
| Email |
sudheersneha16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sneha Sudheer |
| Designation |
Post Graduate |
| Affiliation |
Ramaiah Medical college |
| Address |
Ramaiah Medical College,
Department of Physiotherapy,
M S Ramaiah Nagar,
MSRIT POST,
Bangalore, 560054
Ramaiah Medical College,
Department of Physiotherapy,
M S Ramaiah Nagar,
MSRIT POST,
Bangalore, 560054
Bangalore
KARNATAKA
560054
India |
| Phone |
09916695072 |
| Fax |
|
| Email |
sudheersneha16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nanda KumarS |
| Designation |
Asst Professor |
| Affiliation |
Ramaiah Medical college |
| Address |
Ramaiah Medical College,
Department of Physiotherapy,
M S Ramaiah Nagar,
MSRIT POST,
Bangalore, 560054
Ramaiah Medical College,
Department of Physiotherapy,
M S Ramaiah Nagar,
MSRIT POST,
Bangalore, 560054
Bangalore
KARNATAKA
560054
India |
| Phone |
9900952657 |
| Fax |
|
| Email |
nandakumar.s@msrmc.ac.in |
|
|
Source of Monetary or Material Support
|
| Ramaiah Medical College,
Department of Physiotherapy,
M S Ramaiah Nagar,
MSRIT POST,
Bangalore, 560054 |
|
|
Primary Sponsor
|
| Name |
M S Ramaiah Medical College |
| Address |
M S Ramaiah Medical College and hospital,
Department of Physiotherapy,
M S Ramaiah Nagar,
MSRIT POST,
Bangalore, 560054 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Self |
Ramaiah Medical College,
Department of Physiotherapy,
M S Ramaiah Nagar,
MSRIT POST,
Bangalore, 560054 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sneha Sudheer |
M S Ramaiah Medical college |
Ramaiah Medical college,
Department of Physiotherapy,
M S Ramaiah Nagar,
MSRIT post,
Bangalore 560054
Bangalore
KARNATAKA |
9916695072
sudheersneha16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MSRMC Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G63||Polyneuropathy in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosis of type 1 or type 2 diabetes and diabetic neuropathy
2.DPN with turning fork grading < 4
|
|
| ExclusionCriteria |
| Details |
1.Active foot ulceration
2.Orthopaedic or surgical problems which would disturb the gait parameters
3.Subjects walking with walking aid
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gait analysis |
Gait analysis 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| accelerometer |
1 year |
|
Target Sample Size
Modification(s)
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
25/10/2020 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is an observational ,cross-sectional study, analyzing the temporal gait parameters, center of pressure and pelvic movements of the patients with diabetic peripheral neuropathy while they are dual tasking. The study includes eighty six patients age sex match subjects out of which forty three are diabetic peripheral neuropathy patients and the remaining forty three are normal population. |