| CTRI Number |
CTRI/2024/08/073080 [Registered on: 29/08/2024] Trial Registered Prospectively |
| Last Modified On: |
22/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Process of Care Changes
Behavioral
Other (Specify) [Therapy] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
mirror therapy on fracture rehabilitation |
|
Scientific Title of Study
|
Efficacy of free range of motion exercise based on mirror therapy on fracture rehabilitation in patient with upper arm fracture. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ranjana Sharma |
| Designation |
Professor cum Principal, SMCON |
| Affiliation |
Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe) Wardha |
| Address |
Shainitai Meghe College of Nursing, Salod (Hirapur) Wardha
AVBR Hospital, Orthopedic wards
Wardha
MAHARASHTRA
442001
India |
| Phone |
9960027855 |
| Fax |
|
| Email |
ranjana.msn@dmiher.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranjana Sharma |
| Designation |
Professor cum Principal, SMCON |
| Affiliation |
Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe) Wardha |
| Address |
Shainitai Meghe College of Nursing, Salod (Hirapur) Wardha
Orthopedic Ward, AVBRH, Sawangi (Meghe) Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9960027855 |
| Fax |
|
| Email |
ranjanasharma1234@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ranjana Sharma |
| Designation |
Professor cum Principal, SMCON |
| Affiliation |
Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe) Wardha |
| Address |
Shainitai Meghe College of Nursing, Salod (Hirapur) Wardha
orthopedic wards no. 35 to 40
Wardha
MAHARASHTRA
442001
India |
| Phone |
9960027855 |
| Fax |
|
| Email |
ranjana.msn@dmiher.edu.in |
|
|
Source of Monetary or Material Support
|
| DMIHER (DU) Sawangi (Meghe) Wardha, Maharashtra, India, Pin-4420107 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Datta Meghe Institute of Higher Education and Research,Sawangi (Meghe) Wardha, Maharashtra, India, Pin-440107 |
| 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 Ranjana Sharma |
A.V.B.R.H, Sawangi Meghe Wardha, Maharashtra, India, Pin-442107 |
Orthopedic Ward no.38,39,40,41,42
DMIHER (DU) Wardha, Maharashtra, India.
Wardha
MAHARASHTRA |
09960027855
ranjana.msn@dmiher.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DMIHER (DU), Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M219||Unspecified acquired deformity oflimb and hand, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Free Range-of-Motion (ROM) Exercise Based on Mirror Therapy |
Dosage: Not applicable (exercise intervention)
Duration: 8 weeks
Method of Administration: Participants will perform mirror therapy sessions incorporating range-of-motion exercises for 30 minutes per session, 5 sessions per week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with an upper arm fracture.
Both genders and various age groups.
Able to understand and follow instructions for mirror therapy and free range-of-motion exercises.
|
|
| ExclusionCriteria |
| Details |
Patients with concurrent injuries or conditions affecting upper limb function (e.g., neurological disorders).
Severe cognitive impairments or communication barriers that hinder participation in therapy.
Intervention:
Mirror therapy not combined with free range-of-motion exercises.
Studies focusing solely on mirror therapy for lower limb fractures or other conditions not directly related to upper arm fractures.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in range of motion of the upper arm.
Reduction in pain related to the fracture.
Functional outcomes relevant to daily activities.
|
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| patients satisfaction and quality of life |
1 year |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
05/09/2025 |
| 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="1"
Months="1"
Days="7" |
|
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
|
Mirror therapy combined with free range-of-motion exercises as part of rehabilitation. Studies assessing the efficacy of mirror therapy specifically on upper arm fracture rehabilitation. Studies with a clearly defined protocol for mirror therapy exercises. |