| CTRI Number |
CTRI/2025/03/082277 [Registered on: 13/03/2025] Trial Registered Prospectively |
| Last Modified On: |
12/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A study into the course of physical therapy intervention for hand tendon repair: An Exploratory Study
|
|
Scientific Title of Study
|
Exploring the time period for Physiotherapy Intervention in hand tendon repair:
An Exploratory Study
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anuradha Paramshetti |
| Designation |
PG STUDENT |
| Affiliation |
KAHER INSTITUTE OF PHYSIOTHERAPY |
| Address |
ADVANCED PHYSIOTHERAPY, KLE DR PRABHAKAR KORE HOSPITAL BELGAUM KARNATAKA
Belgaum
KARNATAKA
590010
India |
| Phone |
09686348038 |
| Fax |
|
| Email |
madhuri.paramshetti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varun Naik |
| Designation |
Associate professor |
| Affiliation |
KAHER INSTITUTE OF PHYSIOTHERAPY |
| Address |
ADVANCED PHYSIOTHERAPY, KLE DR PRABHAKAR KORE HOSPITAL BELGAUM KARNATAKA
Belgaum
KARNATAKA
590010
India |
| Phone |
9986497065 |
| Fax |
|
| Email |
varunnaik@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varun Naik |
| Designation |
Associate professor |
| Affiliation |
KAHER INSTITUTE OF PHYSIOTHERAPY |
| Address |
ADVANCED PHYSIOTHERAPY, KLE DR PRABHAKAR KORE HOSPITAL BELGAUM KARNATAKA
Belgaum
KARNATAKA
590010
India |
| Phone |
9986497065 |
| Fax |
|
| Email |
varunnaik@klekipt.edu.in |
|
|
Source of Monetary or Material Support
|
| KLE DR. PRABHAKAR KORE HOSPITAL and research center belagavi |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
KLE Institute of Physiotherapy Nehru nagar Belagavi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 anuradha p |
kle dr. prabhakar kore hospital |
kle dr. prabhakar kore hospital
Belgaum
KARNATAKA |
9686348038
madhuri.paramshetti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical Committee KLEU Institute Of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S602||Contusion of wrist and hand, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A: early mobilization
|
Early mobilization group: application of TENS, active assisted range of motion exercise for hands and fingers, active range of motion exercise for hands and fingers
|
| Intervention |
Group B: late mobilization |
Active range of motion for hand and fingers , active resisted range of motion for hands and fingers and mobilization. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants aged 18-60years.
2. Patients diagnosis of hand tendon injury requiring surgical repair.
3. Willingness of the participant
|
|
| ExclusionCriteria |
| Details |
1. Participants with multiple hand injuries requiring complex surgical interventions.
2. Patients gives history of previous hand tendon repair surgery on the affected hand
3. Fracture of upper limb and crush injuries involving factors of hand complex.
• Presence of co morbidities or medical conditions affecting hand function or healing (peripheral neuropathy, rheumatoid arthritis).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Goniometer |
to check Range of motion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| dynamometer, patient related wrist hand evaluation, SF 36 |
to check hand grip strength, to check hand function pre & post intervention & to check quality of life of the patient |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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 |
|
Date of First Enrollment (India)
|
23/03/2025 |
| 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 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
|
| Primary objective :To explore and evaluate early mobilization in hand tendon | | repair-on hand function:- Patient Rated wrist/hand evaluation, range of | | motion:-Goniometer ,pain levels:-Numeric rating scale, quality of life:-SF- | | 36. | | Secondary objective :To explore and evaluate late mobilization in hand tendon | | repair on hand function:-Patient Rated wrist/hand evaluation ,range of | | motion:-Goniometer ,pain levels:-Numeric rating scale, quality of life:-SF- | | 36. INCLUSIONCRITERIA: • Participants aged 18-60years. • Patients diagnosis of hand tendon injury requiring surgical repair. • Willingness of the participant. EXCLUSIONCRITERIA: • Participants with multiple hand injuries requiring complex surgical interventions. • Patients gives history of previous hand tendon repair surgery on the affected hand • Fracture of upper limb and crush injuries involving factors of hand complex. • Presence of co morbidities or medical conditions affecting hand function or healing (peripheral neuropathy, rheumatoid arthritis). OUTCOME MEASURES goniometer dynamometer patient rated hand wrist evaluation SF 36 | |