| CTRI Number |
CTRI/2023/06/053486 [Registered on: 02/06/2023] Trial Registered Prospectively |
| Last Modified On: |
28/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
A comparison between gravity-operated and spring-assisted knee lock for KAFO |
|
Scientific Title of Study
|
EZ-LOCK Orthosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sujatha Srinivasan |
| Designation |
Professor |
| Affiliation |
Indian Institute Of Technology, Madras |
| Address |
Department of Mechanical Engineering
IIT Madras
Chennai
TAMIL NADU
600036
India |
| Phone |
|
| Fax |
|
| Email |
sujsree@iitm.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujatha Srinivasan |
| Designation |
Professor |
| Affiliation |
Indian Institute Of Technology, Madras |
| Address |
Department of Mechanical Engineering
IIT Madras
TAMIL NADU
600036
India |
| Phone |
|
| Fax |
|
| Email |
sujsree@iitm.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujatha Srinivasan |
| Designation |
Professor |
| Affiliation |
Indian Institute Of Technology, Madras |
| Address |
Department of Mechanical Engineering
IIT Madras
TAMIL NADU
600036
India |
| Phone |
|
| Fax |
|
| Email |
sujsree@iitm.ac.in |
|
|
Source of Monetary or Material Support
|
| INAE Abdul Kalam Technology Innovation National Fellowship |
|
|
Primary Sponsor
|
| Name |
TTK CenteR for Rehabilitation Research and Device Development, IIT Madras |
| Address |
311, Second Floor, Machine Design Section
Indian Institute of Technology Madras
Chennai 600036 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Mobility India |
7812, 1st Cross Rd, Marenahalli, 2nd Phase, J. P. Nagar, Bengaluru, Karnataka 560078 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sujatha Srinivasan |
Mobility India |
7812, 1st Cross Rd, Marenahalli, 2nd Phase, J. P. Nagar, Bengaluru, Karnataka 560078
Bangalore
KARNATAKA |
9444927559
r2d2iitm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IITM - INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G14||Postpolio syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Drop Lock type Knee-Joint Lock |
Gravity based Drop Lock for Knee Ankle Foot Orthosis (KAFO)
An initial assessment will be taken with activities using the drop lock.
A 21 day intervention will be given using the EZ- LOCK.
The post-intervention assessment and follow-up assessment will be taken for all participants using both the drop lock and the EZ LOCK to compare their efficiency |
| Intervention |
EZ-LOK - Knee Joint Lock |
Cable-operated, Spring loaded type of Knee-Joint lock for Knee Ankle Foot Orthosis (KAFO)
After a pre-intervention assessment of activities with the EZ-LOCK, training will be provided with this lock for 21 days, after which a post-assessment will be done.
A follow-up assessment will be taken with this lock 30 days after the initial assessment |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) Quadriceps muscle weakness with (MRC<3)
2) People who independently walk with unilateral/bilateral KAFO for at least 100 m
3) People who transfer independently with unilateral/bilateral KAFO
4) Upper limb strength sufficient to operate the new knee joint
5) Over 1 m tall
|
|
| ExclusionCriteria |
| Details |
1) Impaired cognition
2) Impaired perception
3) Fair to poor standing balance when using unilateral/bilateral KAFO
4) Acute pain in hip, knee and ankle joint
5) Knee flexion contracture greater than 10°
6) Pregnant women
7) Children
8) Abnormal BP
9) Orthostatic hypotension
10) Cardio vascular condition
11) Severe osteoarthritis
12) Standing endurance less than 15 minutes
13) Sensory impairment
14) Poor coordination
15) Poor dexterity
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ease of Use and Reliability of locking |
Pre-Intervention - Evaluation to be done on day 0
Post-Intervention - To be done 21 days after evaluation
Follow up - To be done 30 days after evaluation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gait Stability |
Pre-Intervention - Evaluation to be done on day 0
Post-Intervention - To be done 21 days after evaluation
Follow up - To be done 30 days after evaluation |
| Actuation Speed |
Pre-Intervention - Evaluation to be done on day 0
Post-Intervention - To be done 21 days after evaluation
Follow up - To be done 30 days after evaluation |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
15/06/2023 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response (Others) - Only the published data can be viewed by anyone who has access to the publication
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - As supplementary information, if required by the publication
- For how long will this data be available start date provided 01-01-2024 and end date provided 01-01-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
The study is being conducted to compare the functioning and efficacy of a newly designed orthotic knee joint called EZ-LOCK against conventional drop lock type orthotic knee joint for KAFO (knee ankle foot orthoses) users.
It is hypothesised that the EZ-LOCK joint will simplify and ease stand-to-sit and sit-to-stand transitions while being safe and effective compared to a conventional drop-lock KAFO, for both unilateral and bilateral KAFO users.
15 users have been recruited until now
|