| CTRI Number |
CTRI/2023/11/060364 [Registered on: 30/11/2023] Trial Registered Prospectively |
| Last Modified On: |
29/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Hand Function Comparison: Individuals with Extensor Tendon Injuries versus Those with Normal Hands |
|
Scientific Title of Study
|
Comparison of hand function among individuals with extensor tendon injuries and individuals with normal hand function |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vineetha Devassykutty |
| Designation |
Post graduate student-Occupational Therapy |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7510774162 |
| Fax |
|
| Email |
vineetha.mchpmpl2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shovan Saha |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9880059426 |
| Fax |
|
| Email |
shovan.saha@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shovan Saha |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9880059426 |
| Fax |
|
| Email |
shovan.saha@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Occupational Therapy in Kasturba Hospital |
|
|
Primary Sponsor
|
| Name |
Vineetha Devassykutty |
| Address |
Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Mithun Pai G |
Kasturba Hospital |
Kasturba Hospital, Department of Occupational Therapy,
Manipal
Udupi
KARNATAKA |
9964279546
mithun.paig@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2(Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M678||Other specified disorders of synovium and tendon, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Extensor Tendon Injury(all the zones, with/without bony involvement)
8-12 weeks post-surgical intervention |
|
| ExclusionCriteria |
| Details |
Nerve injuries
Bilateral tendon injuries
Flexor tendon injuries
Amputation of fingers
Persons with mental illness, intellectual disabilities, and neurological disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Jebson Tylor Hand Function Test(JTHFT)
Grip and pinch Strength
TAM |
8-12 weeks post-surgical intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
09/12/2024 |
| 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="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Hand function is necessary for daily activities. A decline in manual dexterity can be caused by injury or disease in various populations, leading to a wide range of activity restrictions or limitations, e.g., peeling fruits, dressing, undressing, using mobile phones, writing, eating, etc. Tendon injuries can cause significant functional impairment. Inadequate intervention can lead to deformity, loss of motion, joint contractures, and loss of function. Restoring the hand function following tendon injury remains the most difficult challenge in hand surgery due to adherence, tightness, and scar tissue. Extensor tendon injuries have received less attention in the literature than flexor tendon injuries, and a lack of literature is present on hand function in individuals who have sustained extensor tendon injuries. The study aims to compare hand function among individuals with extensor tendon injuries and individuals with normal hand function. |