| CTRI Number |
CTRI/2026/01/102339 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Autogenic biofeedback combined with hand rehabilitation activities] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Using Body Feedback and Hand Activities To Improve Upper Limb function in people with colles fracture |
|
Scientific Title of Study
|
Effectiveness Of Autogenic Biofeedback Combined With Hand Rehabilitation Activities On Upper Limb Function Among Patients With Colles 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 B NIBEDITA PRIYADARSHINEE |
| Designation |
Assistance professor |
| Affiliation |
Chettinad academy of research and education |
| Address |
OT orthopedic division, Ward Number 24, Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai , Kelambakkam, Chennai, Tamil Nadu, India 603103
Chennai
TAMIL NADU
603103
India |
| Phone |
9778736107 |
| Fax |
|
| Email |
priyadarshineeb@care.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B NIBEDITA PRIYADARSHINEE |
| Designation |
Assistance professor |
| Affiliation |
Chettinad academy of research and education |
| Address |
OT orthopedic division, Ward Number 24, Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai , Kelambakkam, Chennai, Tamil Nadu, India 603103
Chennai
TAMIL NADU
603103
India |
| Phone |
9778736107 |
| Fax |
|
| Email |
priyadarshineeb@care.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr B NIBEDITA PRIYADARSHINEE |
| Designation |
Assistance professor |
| Affiliation |
Chettinad academy of research and education |
| Address |
OT orthopedic division, Ward Number 24, Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai , Kelambakkam, Chennai, Tamil Nadu, India 603103
Chennai
TAMIL NADU
603103
India |
| Phone |
9778736107 |
| Fax |
|
| Email |
priyadarshineeb@care.edu.in |
|
|
Source of Monetary or Material Support
|
| OT Orthopedic division, Ward No. 24, Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai OMR, Kelambakkam, Chennai, Tamil Nadu, India 603103 |
|
|
Primary Sponsor
|
| Name |
LOKESWARAN K |
| Address |
OT Orthopedic division, Ward No. 24, Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai OMR, Kelambakkam, Chennai, Tamil Nadu, India 603103 |
| 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 |
| LOKESWARAN K |
Chettinad General Hospital |
OT orthopedic division, Ward Number 24, Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai , Kelambakkam, Chennai, Tamil Nadu, India 603103
Chennai
TAMIL NADU |
6381867375
lokeswarankumaravel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee for Student Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S525||Fracture of lower end of radius, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Autogenic Biofeedback Combined with Hand Rehabilitation Activities |
Before enrolling each participant in the study, informed consent will be obtained from their participant , using consent forms approved by the Institutional Review Board of Chettinad University Hospital (CHRI, CARE). A total of 30 individuals, aged 18 -60 years and diagnosed with colles fracture will be recruited from the Occupational Therapy And Orthopaedic Department at Chettinad Hospital and Clinics in the Chengalpattu District. After obtaining consent and confirming inclusion criteria, participants will be randomly assigned into two groups: an intervention group (n = 15) and a control group (n = 15). Pre-intervention assessment of the independency will be conducted using the DISABILITY OF ARM SHOULDER AND HAND (DASH).The experimental group will receive AUTOGENIC BIOFEEDBACK COMBINED WITH HAND REHABILITATION ACTIVITIES ON UPPER LIMB , while the Control Group will not receive any intervention by researcher during this time. Eg: Each session will last 30 minutes, 5 days per week, for 4 weeks. After the 4-weeks intervention period, the independency will be reassessed using the same tools DISABILITY OF ARM SHOULDER AND HAND (DASH). Pre- and post-intervention scores will be statistically analysed to evaluate the effectiveness of the intervention. |
| Comparator Agent |
DISABILITY OF ARM SHOULDER AND HAND (DASH) |
The effect of the intervention will be assessed by comparing the results of the pre test collected in the beginning and post test after completing 4 week intervention period. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age group around 18 to 60 Both male and female Diagnosed with unilateral colles fracture, Patient is in early mobilization or post cast removal phase around 4 to 6weeks with fracture radiologically stable, No severe visual impairment
No serious cognitive impairment, No severe pain more than 5 in NPRS scale |
|
| ExclusionCriteria |
| Details |
Unstable fracture or incomplete bone healing, severe pain or swelling that limits active movement,open wound ,infection or post surgical complications in the affected limb, assoiciated nerve injury causing severe motor or sensory loss, multiple fracture or bilateral upper limb injuries |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Disability Of Arm Shoulder And Hand |
Upper limb function will be assessed using Disability Of Arm Shoulder And Hand at baseline (pre intervention) , and reassessed after completion of four weeks of Autogenic Biofeedback Combined with Hand rehabilitation activities (post intervention). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
03/02/2026 |
| 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 Applicable |
| 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
|
Before enrolling each participant in the study, informed consent will be obtained from their participant , using consent forms approved by the Institutional Review Board of Chettinad University Hospital (CHRI, CARE). A total of 30 individuals, aged 18 to 60 years and diagnosed with colles fracture will be recruited from the Occupational Therapy And Orthopaedic Department at Chettinad Hospital and Clinics in the Chengalpattu District. After obtaining consent and confirming inclusion criteria, participants will be randomly assigned into two groups: an intervention group is 15 and a control group is 15. Pre-intervention assessment of the independency will be conducted using the Disability Of Arm Shoulder And Hand (DASH).The experimental group will receive Autogenic Biofeedback Combined With Hand Rehabilitation Activities , while the Control Group will not receive any intervention by researcher during this time. Eg: Each session will last 30 minutes, 5 days per week, for 4 weeks. After theweeks intervention period, the independency will be reassessed using the same tools Disability Of Arm Shoulder And Hand (DASH). Pre and post-intervention scores will be statistically analysed to evaluate the effectiveness of the intervention. |