| CTRI Number |
CTRI/2022/12/047894 [Registered on: 06/12/2022] Trial Registered Prospectively |
| Last Modified On: |
05/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Measurement of fingertip forces to study recovery of hand function in patients with Carpal Tunnel syndrome |
|
Scientific Title of Study
|
Kinetic Assessment of
Recovery of Hand Function in Patients with Carpal Tunnel Syndrome |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohamed Ibrahim B K |
| Designation |
Consultant Surgeon |
| Affiliation |
SRM Institutes for Medical Science |
| Address |
Institute of Craniofacial Aesthetic & Plastic Surgery (ICAPS)
SIMS Vadapalani
Chennai 600026
Chennai
TAMIL NADU
600026
India |
| Phone |
9361610995 |
| Fax |
|
| Email |
mdibrahim99@icloud.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Thomas Jacob |
| Designation |
PhD Scholar |
| Affiliation |
Indian Institute of Technology Madras |
| Address |
Neuromechanics Lab
MSB-207
IIT Madras
Chennai 300036
Chennai
TAMIL NADU
600036
India |
| Phone |
04422575067 |
| Fax |
|
| Email |
am18d600@smail.iitm.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Thomas Jacob |
| Designation |
PhD Scholar |
| Affiliation |
Indian Institute of Technology Madras |
| Address |
Neuromechanics Lab
MSB-207
IIT Madras
Chennai 300036
Chennai
TAMIL NADU
600036
India |
| Phone |
04422575067 |
| Fax |
|
| Email |
am18d600@smail.iitm.ac.in |
|
|
Source of Monetary or Material Support
|
| Non Funded Research Project:
SRM Institutes for Medical Science, Vadapalani, Chennai 600026 |
|
|
Primary Sponsor
|
| Name |
Dr Varadhan SKM |
| Address |
Department of Apllied Mechanics,
IIT Madras |
| Type of Sponsor |
Other [Self-Non funded research] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr K Sridhar |
Institute of Craniofacial, Aesthetic & Plastic Surgery (ICAPS), SIMS, Chennai |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohamed Ibrahim B K |
SIMS |
Institute of Craniofacial, Aesthetic & Plastic Surgery (ICAPS), SIMS Vadapalani, Chennai 600026
Chennai
TAMIL NADU |
9361610995
mdibrahim99@icloud.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SIMS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
CTS Patients opting for corrective surgery |
|
| ExclusionCriteria |
| Details |
History of other neurological and motor illness apart from CTS |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Safety Margin, DASH Score, BCTQ Score
Force and Moments |
Pre-op,Post-op Week 3, Post-op Week 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Range of motion,
Maximal compression force,
EMG |
Pre-op,Post-op Week 3, Post-op Week 5 |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
06/12/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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)?
Response - NO
|
|
Brief Summary
|
This study measures the fingertip forces while grasping an instrumented handle in different conditions to make an objective assessment of recovery of hand function in patients with Carpal Tunnel syndrome (CTS). This is a longitudinal observational study in patients opting for corrective surgery for CTS. The force based metrics will be compared with the standard clinical test scores at different milestones of recovery. |