| CTRI Number |
CTRI/2015/12/006408 [Registered on: 03/12/2015] Trial Registered Prospectively |
| Last Modified On: |
02/12/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [ARTIFICIAL LIMB (PROSTHESIS)] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Artificial limb made of Cane for use in persons with limb loss below the level of the Knee |
|
Scientific Title of Study
|
Comparison of gait parameters with Cane based prosthesis and conventional transtibial prosthesis: A pilot study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NAVIN B P |
| Designation |
Assistant professor Department of Physical Medicine and Rehabilitation |
| Affiliation |
Christian Medical College |
| Address |
Department of PMR Ida Scudder Road
Vellore
TAMIL NADU
632004
India |
| Phone |
9787698900 |
| Fax |
|
| Email |
dr.naveenbp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NAVIN B P |
| Designation |
Assistant professor Department of Physical Medicine and Rehabilitation |
| Affiliation |
Christian Medical College |
| Address |
Department of PMR Ida Scudder Road
Vellore
TAMIL NADU
632004
India |
| Phone |
9787698900 |
| Fax |
|
| Email |
dr.naveenbp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NAVIN B P |
| Designation |
Assistant professor Department of Physical Medicine and Rehabilitation |
| Affiliation |
Christian Medical College |
| Address |
Department of PMR Ida Scudder Road
Vellore
TAMIL NADU
632004
India |
| Phone |
9787698900 |
| Fax |
|
| Email |
dr.naveenbp@gmail.com |
|
|
Source of Monetary or Material Support
|
| FLUID RESEARCH GRANT AND DEPARTMENT FUND FROM CHRISTIAN MEDICAL COLLEGE VELLORE TAMIL NADU |
|
|
Primary Sponsor
|
| Name |
Institutional Fluid Research Grant |
| Address |
CHRISTIAN MEDICAL COLLEGE VELLORE |
| Type of Sponsor |
Private medical college |
|
|
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 |
| NAVIN B P |
Movement Analysis Laboratory or GAIT LAB |
REHABILITATION INSTITUTE, DEPARTMENT OF PMR, CHRISTIAN MEDICAL COLLEGE, BAGAYAM, VELLORE.
Vellore
TAMIL NADU |
04163075241
dr.naveenbp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD CHRISTIAN MEDICAL COLLEGE VELLORE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
BELOW KNEE AMPUTATION (Limb loss), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cane based below Knee prosthesis (artificial limb) |
The Shank and foot component of the below Knee artificial limb (prosthesis) would be fabricated from Cane. |
| Comparator Agent |
Prior conventional transtibial prosthesis (artificial limb) |
Persons with below Knee amputation walk wearing an artificial limb (prosthesis) which is usually fabricated from Plastic and / or metal. This is called a conventional transtibial prosthesis (below Knee artificial limb). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients with unilateral or bilateral below Knee (transtibial) amputation
2 Amputation due to vascular, traumatic, diabetes or other causes
3 Body Mass index from 18 to 30
4 Walking independently in the community in the past with a below Knee prosthesis for atleast 6 months
5 Amputees who reside within 100 Km radius of the Department of Physical Medicine and Rehabilitation, Christian Medical College, Vellore, Tamil Nadu. As this zone falls within the regular follow up area of the Department. |
|
| ExclusionCriteria |
| Details |
1 Age is less than 18 years or more than 65 years
2 Functional impairments in the sound limb
3 Presence of ulcer over the distal end of the residual limb
4 Knee flexion contracture greater than 25 degree
5 Mental or cognitive disorder interfering with walking or cooperation
6 Not willing for follow-up
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Ten meter walk test. The time taken to walk in seconds is recorded for three trials and average measured.
2 Two minute walk test It assesses the distance in meters a person is capable of walking in two minutes. Patient is asked to perform at the fastest speed possible.
3 Timed up and go test It measures the duration in seconds necessary to get up from a chair walk three meter go back to the chair and sit down again. |
Initial measurement would be done at the first visit with a conventional prosthesis. Following which repeat measurement would be done after 3 weeks of fabrication of the cane based prosthesis. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Physiological cost index. Estimates energy cost while walking. It is calculated from the heart rate during rest and while walking. Measured as beats per meter. |
Initial measurement would be done at the first visit with a conventional prosthesis. Following which repeat measurement would be done after 3 weeks of fabrication of the cane based prosthesis. |
| Gait velocity in meter per second |
Initial measurement would be done at the first visit with a conventional prosthesis. Following which repeat measurement would be done after 3 weeks of fabrication of the cane based prosthesis. |
| Gait cadence in steps per minute |
Initial measurement would be done at the first visit with a conventional prosthesis. Following which repeat measurement would be done after 3 weeks of fabrication of the cane based prosthesis. |
| Step width in Centimeter |
Initial measurement would be done at the first visit with a conventional prosthesis. Following which repeat measurement would be done after 3 weeks of fabrication of the cane based prosthesis. |
| Stride length in Centimeter |
Initial measurement would be done at the first visit with a conventional prosthesis. Following which repeat measurement would be done after 3 weeks of fabrication of the cane based prosthesis. |
| Stance swing ratio. The ratio of the time of the stance and swing phase of the gait cycle with the prosthesis. |
Initial measurement would be done at the first visit with a conventional prosthesis. Following which repeat measurement would be done after 3 weeks of fabrication of the cane based prosthesis. |
| Stance duration in seconds. Duration of the stance phase of the gait cycle with the prosthesis. |
Initial measurement would be done at the first visit with a conventional prosthesis. Following which repeat measurement would be done after 3 weeks of fabrication of the cane based prosthesis. |
| Patient satisfaction assessed by Prosthesis Evaluation Questionnaire. |
Questionnaire would be filled at the first visit and after 3 weeks of fabrication of the cane based prosthesis. |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
28/12/2015 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The below Knee (transtibial) artificial limb (prosthesis) consists of a Socket, Shank and a Foot. Socket is the part which is in direct contact with the residual limb and serves as an interface between the stump and the artificial limb (prosthesis). Shank is the part of the artificial limb, which connects the Socket and the Foot. Lower extremity artificial limb (prosthesis) components are made using a wide variety of materials such as Wood, Plastic, Metal and Carbon fiber.
This study aims to assess the efficacy of incorporating a cost effective material like Cane as a component in the the below Knee artificial limb (transtibial prosthesis). Following fabrication of the prosthetic socket as per current good clinical practices, the Shank and the Foot of the artificial limb would be fabricated with the use of Cane. This may make the prosthesis cheaper, lighter and easy to maintain in the community. In addition, the amputee’s may be able to walk barefoot and squat. The ability to walk barefoot and squat are important with reference to social and cultural practices in India. In the event of a natural disaster, fabrication of a Cane based prosthesis may be easier as compared to conventional prosthesis.
Patients with below Knee amputation would be screened in the Department of Physical Medicine and Rehabilitation for fulfilling the eligibility criteria. Participants must have been community ambulators (walkers) for at-least six months with a conventional below Knee artificial limb (transtibial prosthesis). For those who consent to participate in the study, a Cane based below Knee artificial limb (transtibial prosthesis) would be fabricated. The primary outcome measures which would used in the study (10 meter walk test, 2 minute walk test, Timed up and go test) have been validated. An objective gait analysis would be done in the Gait lab, Department of Physical Medicine and Rehabilitation - initially at first visit with a conventional below Knee artificial limb (transtibial prosthesis) and after 3 weeks of fabrication of the Cane based below Knee artificial limb (transtibial prosthesis). Prosthesis Evaluation Questionnaire (sub-group 1, 4 and 5) would be filled at initial visit and after 3 weeks of fabricating Cane based artificial limb (prosthesis) to assess patient satisfaction and mobility. Data would then be compared and reported. |