| CTRI Number |
CTRI/2025/11/097763 [Registered on: 20/11/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessing the effectiveness of 6 weeks of mirror therapy on fine motor recovery in individuals with post-traumatic brain injury: A quasi experimental study. |
|
Scientific Title of Study
|
Assessing the effectiveness of 6 weeks mirror therapy on fine motor recovery in individuals with post traumatic brain injury: A quasi experimental study. |
| Trial Acronym |
N/A |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kulvinder Kaur |
| Designation |
PG Student |
| Affiliation |
Dayananda Sagar Collage of Physiotherapy, Dayananda Sagar University,. |
| Address |
Dayananda Sagar Collage of Physiotherapy, Dayananda Sagar University, Devarakaggalahali Harohalli, south Bengaluru
Bangalore KARNATAKA 562112 India |
| Phone |
9034234276 |
| Fax |
|
| Email |
kulvinderkaur1324@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sandhya Eluri |
| Designation |
Assistant professor |
| Affiliation |
Dayananda Sagar Collage of Physiotherapy, Dayananda Sagar University. |
| Address |
Dayananda Sagar Collage of Physiotherapy, Dayananda Sagar University, Devarakaggalahali Harohalli, south Bengaluru
Bangalore KARNATAKA 562112 India |
| Phone |
9047082970 |
| Fax |
|
| Email |
sandhyaeluri91@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Olivia Rose Mary |
| Designation |
Assistant professor |
| Affiliation |
Dayananda Sagar Collage of Physiotherapy, Dayananda Sagar University. |
| Address |
Dayananda Sagar Collage of Physiotherapy, Dayananda Sagar University, Devarakaggalahali Harohalli, south Bengaluru
Bangalore KARNATAKA 562112 India |
| Phone |
9739322961 |
| Fax |
|
| Email |
oliviarm98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayananda Sagar Collage of Physiotherapy, Dayananda Sagar University, Devarakaggalahali Harohalli, south Bengaluru |
|
|
Primary Sponsor
|
| Name |
Dayananda Sagar Collage of Physiotherapy, Dayananda Sagar University. |
| Address |
Dayananda Sagar Collage of Physiotherapy, Dayananda Sagar University, Devarakaggalahali Harohalli, south Bengaluru |
| Type of Sponsor |
Other [Private University] |
|
|
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 Sandhya Eluri |
Dayananda Sagar Collage of Physiotherapy, Neuro physiotherapy opd, Dayananda Sagar University |
Dayananda Sagar Collage of Physiotherapy, Dayananda Sagar University, Devarakaggalahali Harohalli, south Bengaluru Bangalore KARNATAKA |
9047082970
Sandhyadevi-physio@dsu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Collage of Physiotherapy, Dayananda Sagar University. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S062||Diffuse traumatic brain injury, (2) ICD-10 Condition: S063||Focal traumatic brain injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mirror Therapy |
The patient should sit comfortably with the mirror between their affected and unaffected limbs. Patients are asked to align the reflection of their unaffected limb with the position of their affected limb so that the reflection appears as if it is in the same location as the affected limb hidden behind the mirror.
7 sessions/week for 6 weeks |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Mild to moderate post-traumatic brain injury ( GCS for mild TBI is 13-15 and for moderate TBI is 9-12)
Sub-acute (1 month) to chronic( 1 year or more) Traumatic brain injury.
RLA stage is 7,8,9,10
No or mild cognitive impairment (mini-mental state examination score between 21 to 30)
AGE: 19-40 years
Unilateral hemiparesis
Brunnstrom recovery stage for hand: 4 to 5
Trunk impairment score :14 or more
|
|
| ExclusionCriteria |
| Details |
Any history of other neurological disorders, such as stroke or spinal cord injury.
Any history of seizure disorder.
Any history of cardiovascular disorder.
Musculoskeletal pathology in the afflicted UE might impair joints in the affected segment.
Must have undergone botulinum toxin injections or other local anti-spastic treatments within 6 months of examination.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Wolf motor function test
Fugl-Meyer assessment |
Day 0, 3 weeks, 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="22" Sample Size from India="22"
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)
|
01/12/2025 |
| 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
|
Title: Assessing the effectiveness of 6 weeks of mirror therapy on fine motor recovery in individuals with post-traumatic brain injury. This study evaluates whether six weeks of mirror therapy can significantly improve fine motor skills—hand dexterity and hand strength—in individuals with post-traumatic brain injury (TBI). A quasi-experimental design with 22 participants, recruited through convenient sampling according to inclusion criteria from rehabilitation centres in South Bangalore. Mirror therapy is delivered by placing the affected hand behind a mirror while the unaffected hand performs movements that create a visual illusion, stimulating motor recovery through mirror neuron activation. Mirror therapy will be given for 7 days/week for 6 weeks. Assessments will be taken at baseline, 3 weeks, and 6 weeks using validated tools: the Wolf Motor Function Test and Fugl-Meyer Assessment, and the results will be analysed and interpreted. z |