| CTRI Number |
CTRI/2024/05/067349 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
08/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing the Accuracy of Weight Bearing Sensors for Monitoring Lower Extremity Fracture Rehabilitation During Walking Training |
|
Scientific Title of Study
|
Reliability Of Weight Bearing Sensors To Monitor The Precise Loading Of Weight In The Lower Extremity Fracture During Walking Training. |
| Trial Acronym |
NIl |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mani Selva Anisha |
| Designation |
PG Student |
| Affiliation |
The Oxford College of Physiotherapy |
| Address |
The Oxford College Of Physiotherapy,Department of Musculoskeletal Science
No.6/9, 1st Cross, Begur Road, Hongasandra, Bangalore-560068
Bangalore
KARNATAKA
560068
India |
| Phone |
7550213050 |
| Fax |
|
| Email |
anishajoe24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R V Vijay Kumar |
| Designation |
Professor |
| Affiliation |
The Oxford College Of Physiotherapy |
| Address |
The Oxford College Of Physiotherapy,Department of Musculoskeletal Science.
No.6/9, 1st Cross, Begur Road, Hongasandra, Bangalore-560068
Bangalore
KARNATAKA
560068
India |
| Phone |
9448482319 |
| Fax |
|
| Email |
rvvijayphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Vasanthan |
| Designation |
Principal |
| Affiliation |
The Oxford College Of Physiotherapy |
| Address |
The Oxford College Of Physiotherapy, Department of Neuroscience.
No.6/9, 1st Cross, Begur Road, Hongasandra, Bangalore-560068
Bangalore
KARNATAKA
560068
India |
| Phone |
9916919685 |
| Fax |
|
| Email |
physiotherapyprincipal@theoxford.edu |
|
|
Source of Monetary or Material Support
|
| Curemaxx Hospitals
861, 4/158, Begur road, Hongasandra, Bangalore |
| Sanjay Gandhi Institute of Trauma and Orthopaedics
Byrasandra Main Road,Behind Nimhans Hospital,CHCS Layout,1st Block Jayanagar East. |
| Sonu Hospital
Begur road, next to Pai Internatinal, Hongasandra, Bangalore |
| The Oxford Medical College, Hospital and Research centre.
Yadavanahalli, Attibele, Bengaluru 562107 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mani Selva Anisha |
The Oxford College of Physiotherapy |
Department of Physiotherapy OPD,No.6/9, 1st Cross, Begur Road, Hongasandra, Bangalore-560068
Bangalore
KARNATAKA |
7550213050
anishajoe24@gmai.com |
| Mani Selva Anisha |
The Oxford Medical College, Hospital and Research centre |
Yadavanahalli, Attibele, Department of Physiotherapy. Bengaluru 562107
Bangalore
KARNATAKA |
7550213050
anishajoe24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Oxford College of Physiotherapy Review Board for Ethics and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S828||Other fractures of lower leg, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Age Group 20-40 years.
Both male and female.
BMI 18.5-24.9
Patients using walker or axillary crutches.
Unilateral Lower extremity fracture patients.
The subject should be referred by treating Orthopedician for progressive weight bearing walking.
Participants who are able to bear different percentage of weight on the affected lower extremity.
Participants in different stages of recovery of progressive weight bearing.
|
|
| ExclusionCriteria |
| Details |
Unable to bear weight due to post surgical complications
Excessive pain on weight bearing
Upper extremity Fracture
Delayed malunion and non-union post fracture
Neurological disorder
Cognitive disorder
Peripheral sensory disorder
Unable to understand commands
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Weight Bearing Sensor Device |
0-1 Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Usability evaluation questionnaire of walking devices |
0-1 Day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
19/05/2024 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Background: Fractures, often from trauma, can be complex, requiring proper treatment to avoid complications. Weight-bearing rehabilitation is crucial, with early initiation recommended for optimal healing and preventing bone density loss. Various weight-bearing grades guide rehabilitation, including Full Weight-Bearing and Non-Weight-Bearing. In healthcare, the development of miniature, wireless, and low-power in-shoe foot plantar sensors is vital for efficient monitoring of daily activities, with applications in data transfer and biomedical sensing. Method:The study consists of two steps: Step 1 focuses on assessing the reliability of a weight-bearing sensor during walking. The procedure involves measuring the subject’s weight, calibration trials with the weight-bearing sensor device, and walking for 20m with incremental weight adjustments. The mobile app will alert the subject if they exceed permitted weight, storing errors. Consistency in applying planned weight across trials will be analyzed. If correct weight bearing is present in over 80% of trials, the equipment is deemed reliable Step 2 involves analyzing a Usability Evaluation Questionnaire for a walking device. Subjects meeting selection criteria, referred by orthopedic doctors for partial weight-bearing training, will receive an explanation of the study’s purpose. Informed consent will be obtained before participation. |