| CTRI Number |
CTRI/2021/12/038733 [Registered on: 20/12/2021] Trial Registered Prospectively |
| Last Modified On: |
14/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Other (Specify) [prosthetics intervention] |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Effect of adjustment in orientation of artificial limbs on balance and posture for patients who lost their limbs at below knee level |
|
Scientific Title of Study
|
A Study on Effect of alteration in angular alignment on Balance and Posture in subjects with valgus stump using unilateral transtibial prosthesis
|
| Trial Acronym |
No |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ranjith R |
| Designation |
Post Graduate Scholar |
| Affiliation |
Swami Vivekanand National Institute of Rehabilitation Training and Research (SVNIRTAR), Cuttack |
| Address |
MPO Section
Department of Prosthetics & Orthotics
Swami Vivekanand National Institute of Rehabilitation Training and Research (SVNIRTAR)
Cuttack
Cuttack
ORISSA
754010
India |
| Phone |
9110870190 |
| Fax |
|
| Email |
rainadpo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajesh Kumar Mohanty |
| Designation |
Lecturer (Prosthetics & Orthotics) |
| Affiliation |
Swami Vivekanand National Institute of Rehabilitation Training and Research (SVNIRTAR), Cuttack |
| Address |
MPO Section, Department of Prosthetics & Orthotics, Swami Vivekanand National Institute of Rehabilitation Training and Research (SVNIRTAR),
At: Olatpur,Post: Bairoi, Cuttack, Odisha, India
Cuttack
ORISSA
754010
India |
| Phone |
9040400795 |
| Fax |
|
| Email |
rajeshmpo48@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajesh Kumar Mohanty |
| Designation |
Lecturer (Prosthetics & Orthotics) |
| Affiliation |
Swami Vivekanand National Institute of Rehabilitation Training and Research (SVNIRTAR), Cuttack |
| Address |
MPO Section, Department of Prosthetics & Orthotics, Swami Vivekanand National Institute of Rehabilitation Training and Research (SVNIRTAR),
At: Olatpur,Post: Bairoi, Cuttack, Odisha, India
Cuttack
ORISSA
754010
India |
| Phone |
9040400795 |
| Fax |
|
| Email |
rajeshmpo48@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Prosthetics & Orthotics, Swami Vivekanand National Institute of Rehabilitation Training and Research (SVNIRTAR), At: Olatpur, P.O: Bairoi, Dist.: Cuttack - 754010, Odisha, India
|
|
|
Primary Sponsor
|
| Name |
wami Vivekanand National Institute of Rehabilitation Training and Research |
| Address |
At: Olatpur, P.O: Bairoi, Dist.: Cuttack - 754010, Odisha
|
| 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 |
| Rajesh Kumar Mohanty |
Swami Vivekanand National Institute of Rehabilitation Training and Research (SVNIRTAR) |
MPO Section, Department of Prosthetics & Orthotics, Swami Vivekanand National Institute of Rehabilitation Training and Research (SVNIRTAR), At: Olatpur, P.O: Bairoi, Dist.: Cuttack - 754010, Odisha, India
Cuttack
ORISSA |
9040400795
rajeshmpo48@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Scientific Committee of Swami Vivekanand National Institute of Rehabilitation Training and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Prosthesis |
Subjects who have used the Prosthesis for a minimum period of 6 months and 4 hours per day. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Only unilateral transtibial amputees will be considered.
Short Stump with valgus alignment up to 20 degrees.
Full ROM of shoulder, elbow and wrist joint and strength minimum more than 4 in MMT.
No contracture in the proximal joint.
Able to understand the command.
|
|
| ExclusionCriteria |
| Details |
Other associated Neurological or Orthopaedical condition, Complicated stump (pain, wound, etc), Significant pathology in cardiopulmonary status.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Path length or COP displacement (cm)
2. Stability score (%)
3. Average Velocity (cm/sec)
4. Mobility score (%)
5. Postural Compensation (mm)
6. Temporal-Spatial Gait parameters
7. Kinematics of Hip, Knee and Ankle
8. Ground Reaction Forces (Kinetics) |
At 1 Week Intervals |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient Satisfaction Level and Quality of Life |
500 Min |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "15"
Final Enrollment numbers achieved (India)="15" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/12/2021 |
| Date of Study Completion (India) |
14/01/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="5" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The objective of this study is to check whether significant difference exist between any of the three alignment alteration conditions (Neutral,N+5,N+10) with respect to balance and postural parameters in subjects with valgus stump using unilateral trnastibial amputation.
HYPOTHESIS: There will be significant improvement in static balance and posture due to alternation of prosthetic alignment
NULL HYPOTHESIS: There will not be any significant differences in static balance and posture by due to alternation of prosthetic alignment. |