| CTRI Number |
CTRI/2024/11/076974 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
18/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Foot and ankle exercise for Diabetic patients to identify these exercise effect on gait parameters |
|
Scientific Title of Study
|
Effect of Foot Ankle Exercise Program on Gait Parameters among Patients with Diabetic Peripheral Neuropathy |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ayshath Nihala |
| Designation |
Post Graduate resident |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
Yenepoya Physiotherapy College,
6th Floor, Naringana campus, Derlakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8129994587 |
| Fax |
|
| Email |
nihala448@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lourdhuraj I |
| Designation |
Principal |
| Affiliation |
Yenepoya Physiothereapy College |
| Address |
Yenepoya Physiotherapy College
6th Floor, Naringana, Derlakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9940529169 |
| Fax |
|
| Email |
lourdhuraj@yenepoya.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Lourdhuraj I |
| Designation |
Principal |
| Affiliation |
Yenepoya Physiothereapy College |
| Address |
Yenepoya Physiotherapy College,
6tH floor,Naringana, Derlakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9940529169 |
| Fax |
|
| Email |
lourdhuraj@yenepoya.edu.in |
|
|
Source of Monetary or Material Support
|
| Yenepoya Physiotherapy College, 6th Floor, Naringana, Derlakatte, Mangalore-575018
Karnataka |
|
|
Primary Sponsor
|
| Name |
Ayshath Nihala |
| Address |
Yenepoya, Physiotherapy college, 6th Floor, Naringana, Derlakatte, Managalore-575018, Karnataka |
| 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 |
| Dr Lourdhuraj I |
Yenepoya Medical College Hospital |
Yenepoya Medical College Hospital, 2nd Floor, General Medicine Department, derlakatte-575018
Dakshina Kannada
KARNATAKA |
9940529169
lourdhuraj@yenepoya.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee-1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G64||Other disorders of peripheral nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Foot Ankle exercise program |
4-weeks,
40 minutes exercise including 5minutes warm up and 5 minutes cool down
each exercise will be given a set of 2 with 30 repititions
Heel-Toe raises, gripping objects with toes, Inversion and eversion, toes spreading with the heel on the ground, stamping heel on the floor, High march walk and tandem walk- 10meter approx. Unipedal stance
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Can walk up to 10 m independently
Mild and Moderate DPN
|
|
| ExclusionCriteria |
| Details |
History of ulcers
History of any toe amputations
History of any neurological conditions other than DPN
Any musculoskeletal conditions and cardiac conditions.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.10-meter walk test
2. stride length |
pre and post interevention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
29/11/2024 |
| 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="1"
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
|
A Quasi-experimental study where participants will receive a foot-ankle exercise program for 4 weeks. The study will include 25 participants based on the inclusion and exclusion criteria of the study. The gait parameters will be tested using 10mWT. The step length will be measured using inch tape from heel strike of one foot to heel strike of the opposite foot. The overall procedure including the advantages, Needs, and Limitations of the study will be explained to the participants and informed consent will be obtained before the study. |