| CTRI Number |
CTRI/2019/09/021021 [Registered on: 02/09/2019] Trial Registered Prospectively |
| Last Modified On: |
03/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of mobilization in patients with wrist fracture |
|
Scientific Title of Study
|
Efficacy of mobilization with
movement in patients with Colles fracture: A randomized clinical trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vishista Biswas |
| Designation |
Post Graduate Student |
| Affiliation |
Nitte Institute of Physiotherapy |
| Address |
Nitte Institute of Physiotherapy, Office room, Ground floor, Nithyananda nagar, Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9561712948 |
| Fax |
|
| Email |
vishistabiswas21@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Saumya Srivastava |
| Designation |
Assistant Professor |
| Affiliation |
Nitte Institute of Physiotherapy |
| Address |
Nitte Institute of Physiotherapy, Office room, Ground floor, Nithyananda nagar, Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9740244077 |
| Fax |
|
| Email |
saumyasri2000@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Saumya Srivastava |
| Designation |
Assistant Professor |
| Affiliation |
Nitte Institute of Physiotherapy |
| Address |
Nitte Institute of Physiotherapy, Office room, Ground floor, Nithyananda nagar, Deralakatte, Mangalore
Shimoga
KARNATAKA
575018
India |
| Phone |
9740244077 |
| Fax |
|
| Email |
saumyasri2000@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Vishista Biswas, Nitte institute of physiotherapy, Office room, Ground floor, Nithyananda nagar, Deralakatte, Mangalore, Dakshina Kannada, Karntaka- 575018, India. |
|
|
Primary Sponsor
|
| Name |
Vishista Biswas |
| Address |
Nitte institute of physiotherapy, Office room, Ground floor, Nithyananda nagar, Deralakatte, Mangalore, Dakshina Kannada, Karntaka- 575018, India. |
| 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 |
| Vishista Biswas |
Justice KS Hegde Charitable Hospital |
Department of physiotherapy, Basement 2, Room no. 20, NITTE University, Deralakatte, Mangalore.
Dakshina Kannada
KARNATAKA |
9561712948
vishistabiswas21@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M978||Periprosthetic fracture around other internal prosthetic joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy |
Parffin Wax Bath:- 15 mins
Active exercises, soft tissue stretches, isometric stabilizing exercises, and gentle grip strengthening exercises
Repitation:- 10 times
Intervention Time:- 7 Days |
| Intervention |
Mobilization with movement in patients with Colles fracture |
Wax Bath:- 15 mins
Glides:- flexion, extension, supination, pronation, ulnar deviation, radial deviation
Repitation:- 10 times
Intervention Time:- 7 Days |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Colles Fracture, conservative or internal fixator, with or without deformity |
|
| ExclusionCriteria |
| Details |
Osteopenia, sudecks dystrophy |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Michigan Hand Outcomes Questionnaire (MHQ) |
On first day and last day of treatment (1 week intervention) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hand Dynamometer |
On first day and last day of treatment (1 week intervention) |
| Visual Analog Scale |
On first day and last day of treatment (1 week intervention) |
| Goniometer |
On first day and last day of treatment (1 week intervention) |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
03/09/2019 |
| Date of Study Completion (India) |
31/01/2020 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The purpose of the study is to compare the effect of mobilization with movement with conventional physiotherapy in patients with Colle’s fracture and their effect on pain and disability as well. There seems to be no specific literature regarding the effect of Mulligan concept of Mobilization with movement therapy. Hypothesis is Mulligan concept of mobilization with movement and conventional physiotherapy treatment following Colle’s Fracture may be equally effective in terms of range of motion, functional activities and grip strength.
|