| CTRI Number |
CTRI/2025/07/090743 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Finding The Impact of functional Training on Range of Motion, Strength, and Performance in Distal end radius patient stabilized with Volar Plate Fixation -A Case series
|
|
Scientific Title of Study
|
Effect of Functional Training on Range of motion, Strength and Functional Performance in patients with Distal End Radius Fracture stabilized with Volar Plate Fixation -A Case series
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Purva Raju Gandhi |
| Designation |
Postgraduate student |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation college of Physiotherapy
11/12 Thube Park, Shivajinagar,Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
7387678590 |
| Fax |
|
| Email |
purvagandhi08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Siddhanth Sawant |
| Designation |
Associate Professor,Department of Kinesiotherapy and Physical Diagnosisapy |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation college of physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation college of Physiotherapy Department of Musculoskeletal
11/12 Thube Park, Shivajinagar,Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
9833680079 |
| Fax |
|
| Email |
sawantsiddhanth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Siddhanth Sawant |
| Designation |
Associate Professor,Department of Kinesiotherapy and Physical Diagnosisapy |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation college of physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation college of Physiotherapy Department of Musculoskeletal
11/12 Thube Park, Shivajinagar,Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
9833680079 |
| Fax |
|
| Email |
sawantsiddhanth@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy, 11/12 Thube Park, 16, 16, Shivajinagar, Pune, Maharashtra 411005, India |
|
|
Primary Sponsor
|
| Name |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy
11/12 Thube Park, 16, 16, Shivajinagar, Pune, Maharashtra 411005, India |
| 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 Purva Raju Gandhi |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
Sancheti Hospital
Shivajinagar, Basement, room no 1, Pune, 411005, Maharashtra, India
Pune
MAHARASHTRA |
7387678590
purvagandhi08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sancheti Institute for Orthopaedics and Rehabilitation Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M966||Fracture of bone following insertion of orthopedic implant, joint prosthesis, or bone plate, (2) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Functional Training |
Conventional Treatment with Functional Trainingl like making a fist,squeezing a soft foam ball,throwing a dart at different distance,scoop and sup,turning a knob for 6 weeks with 3 sessions per week for a period of 6 weeks. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age over 40 -65 years
Surgically managed distal end radius fracture with volar plate fixation
Stable fixation ,deemed by surgeon to be suitable for mobilization
|
|
| ExclusionCriteria |
| Details |
Concomitant fracture of another bone Concomitant surgery for injury that significantly affects normal use of operated limb
Any preexiting condition or injury that significantly affects normal use of operated limbs
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Universal Goniometer
Handheld Dynamometer
Pinchometer |
At baseline at 0 weeks & after intervention after 6
weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pinchometer |
At baseline (0 weeks) & after intervention (after 6
weeks) |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "31"
Final Enrollment numbers achieved (India)="31" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/08/2025 |
| Date of Study Completion (India) |
16/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Distal end radius fracture is the fracture approximately 2cm above distal articular surface of radius at junction where cortical bone becomes thinner and is reinforced by trabecular network.The common mechanism is falling on an outstretched hand and the prevalence of fracture is 8-15% in adult and 18% elderly. Post operatively fracture are kept immobilized for 4-6 weeks this result in delayed regain of functional use of fractured hand. Delayed return of function following operative fixation of distal end radius fracture can have both financial and quality of life implication for many patients .Thus the reason of the study is to introduce Functional Training as a useful intervention method to the distal end radius fracture and to find the effectiveness of the functional training in the management of range of motion,grip strength and to improve the functional performance in subjects with distal end radius fracture. Outcome measure use to assess range of motion is goniometer,for grip strength is handheld dynamometer, for pinch strength is pinchometer and Patient Rated Wrist Evaluation to measure pain and disability during daily living activities. The patient will recieve Conventional treatment with Functional training for 3 session per week for a period of 6 weeks.
Null Hypothesis: There will be no significant effect of Functional Training on range of motion, grip strength and functional performance in patient with distal end radius fracture stabilized with volar plate fixation. Research Hypothesis: The Functional Training will be effective on range of motion, grip strength and functional performance in patient with distal end radius fracture stabilized with volar plate fixation. |