| CTRI Number |
CTRI/2025/01/079327 [Registered on: 23/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparative analysis of balance between non diabetic and diabetic individuals with single leg loss below knee using artificial limb during turning and climbing steps |
|
Scientific Title of Study
|
Comparative analysis of balance between non diabetic and diabetic individuals with Unilateral Transtibial Amputation using Endoskeletal Prosthesis during turning and negotiating steps. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaibhav Dolas |
| Designation |
Lecturer Physiotherapy |
| Affiliation |
AIIPMR, Mumbai |
| Address |
Physiotherapy Department, All India Institute of Physical Medicine and Rehabilitation, Mahalaxmi, Mumbai
Mumbai
MAHARASHTRA
400034
India |
| Phone |
9820384812 |
| Fax |
|
| Email |
vsdolas21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vaibhav Dolas |
| Designation |
Lecturer Physiotherapy |
| Affiliation |
AIIPMR, Mumbai |
| Address |
Physiotherapy Department, All India Institute of Physical Medicine and Rehabilitation, Mahalaxmi, Mumbai
NA
Mumbai
MAHARASHTRA
400034
India |
| Phone |
9820384812 |
| Fax |
|
| Email |
vsdolas21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vaibhav Dolas |
| Designation |
Lecturer Physiotherapy |
| Affiliation |
AIIPMR, Mumbai |
| Address |
Physiotherapy Department, All India Institute of Physical Medicine and Rehabilitation, Mahalaxmi, Mumbai
Mumbai
MAHARASHTRA
400034
India |
| Phone |
9820384812 |
| Fax |
|
| Email |
vsdolas21@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIPMR, Mahalaxmi, Mumbai 400034 |
|
|
Primary Sponsor
|
| Name |
Vaibhav Dolas |
| Address |
Physiotherapy Dept, All India Institute of Physical Medicine and Rehabilitation, Mahalaxmi, Mumbai 400034. |
| 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 Vaibhav Dolas |
All India Institute of Physical Medicine and Rehabilitation |
Room No. 224 Physiotherapy Department AIIPMR Mahalaxmi Mumbai 400034
Mumbai
MAHARASHTRA |
9820384812
vsdolas21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S881||Traumatic amputation at level between knee and ankle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Two groups
Group I Persons with Non–Diabetic unilateral Transtibial amputation using
PTB endoskeletal prosthesis.
Group II Persons with Diabetic Unilateral Transtibial amputation using PTB
endoskeletal prosthesis.
2. Functional level K3 (K- level functional assessment scale)
3. Persons using prosthesis for more than 3 months.
4. Persons ambulating independently without any walking aid. |
|
| ExclusionCriteria |
| Details |
1.Amputees with a stump length of less than 1/3 rd and more than 2/3 rd of the
unaffected leg
2. Any clinical manifestation or condition which will affect the performance. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. STEP/QUICK TURN (SQT) - Turn time & Turn sway velocity
2. STEP UP/OVER (SUO) - Rising index
(force to rise) movement time and impact index (impact force) |
Only baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
02/02/2025 |
| 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="3"
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
|
Title - Comparative analysis of balance between non diabetic and diabetic individuals with unilateral transtibial amputation using endoskeletal prosthesis during turning and negotiating steps.
Aim - To evaluate and compare balance between non-diabetic and diabetic individuals with unilateral transtibial amputation using endoskeletal prosthesis during and stair climbing.
Objective - 1. To assess the balance in non-diabetic individuals with unilateral transtibial amputation using endoskeletal prosthesis during turning and stair climbing. 2. To assess the balance in diabetic individuals with unilateral transtibial amputation using endoskeletal prosthesis during turning and stair climbing. 3. To compare balance between persons with non-diabetic and diabetic unilaterl transtibial amputation using endoskeletal prosthesis during turning and stair climbing. Participant giving informed consent will be included in the study. Data collected from the study will be statistically analysed.
|