| CTRI Number |
CTRI/2024/04/065252 [Registered on: 05/04/2024] Trial Registered Prospectively |
| Last Modified On: |
03/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To find the effectiveness of specific strategy training with sensory feedback in diabetic neuropathy patients |
|
Scientific Title of Study
|
Effectiveness of strategy specific balance training with sensory feedback in diabetic neuropathy patients |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Thenmozhi M |
| Designation |
MPT student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) Faculty of physiotherapy [OPD] No 1 Ramachandra Nagar Porur Chennai 600 116 Tamil Nadu
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) Faculty of physiotherapy [OPD] No 1 Ramachandra Nagar Porur Chennai 600 116 Tamil Nadu
Chennai
TAMIL NADU
600116
India |
| Phone |
7200371627 |
| Fax |
|
| Email |
t0322013@sriher.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Thenmozhi M |
| Designation |
MPT student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) No 1 Ramachandra Nagar Porur Chennai 600 116 Tamil Nadu
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) No 1 Ramachandra Nagar Porur Chennai 600 116 Tamil Nadu
TAMIL NADU
600116
India |
| Phone |
7200371627 |
| Fax |
|
| Email |
t0322013@sriher.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
A Rajarajeswari |
| Designation |
Associate professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University)
No 1 Ramachandra Nagar Porur Chennai 600 116 Tamil Nadu
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) No 1 Ramachandra Nagar Porur Chennai 600 116 Tamil Nadu
Chennai
TAMIL NADU
6000116
India |
| Phone |
9865802903 |
| Fax |
|
| Email |
rajarajeswari@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research
No 1 Ramachandra Nagar Porur Chennai 600 116 Tamil Nadu |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
No 1 Ramachandra Nagar Porur Chennai 600 116 Tamil Nadu |
| 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 |
| Dr Thenmozhi M |
Sri Ramachandra Institute of Higher Education and Research (G block) |
g-block,2nd floor department of endocrinology No 1 Ramachandra Nagar Porur Chennai 600 116 Tamil Nadu
Chennai
TAMIL NADU |
7200371627
t0322013@sriher.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee For Students Projects DHR/ICMR registration no : EC/NEW/INST/2023/TN/0321 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Diabetic neuropathy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional balance training |
3 days/ week for 2 weeks |
| Intervention |
Strategy specific balance training with sensory feedback |
3 days/week for 2 week |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adults diagnosed with Type II Diabetes Mellitus
Diabetes neuropathic patients with DNS Score of 1 or above
30-60 years of age
Patients with Mini best score of above 12/28 |
|
| ExclusionCriteria |
| Details |
Patients with any other musculoskeletal vestibular and neurological disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mini best scale |
2 weeks (pre and post) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
14/04/2024 |
| 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="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 - NO
|
|
Brief Summary
|
Participants will be explained about the study and informed consent will be obtained Later participants will be allotted to either Interventional or control group by simple random allocation The participants of intervention group patient will undergo strategy specific balance training with sensory feedback along with conventional balance training Control group will undergo conventional balance training Participants will be expected to follow this protocol for a period of 2- week period Participants will be tested before and after the treatment program using MINI BEST scale |