| CTRI Number |
CTRI/2025/07/091266 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [OCCUPATIONAL THERAPY] |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of using Controlled Errors in enhancing Movement and Balance and their Role in Activities of Daily Living in Patients with Stroke |
|
Scientific Title of Study
|
Efficacy of Error Augmentation in motor function and balance and its impact on Activities of Daily Living (ADL) in patients with Stroke |
| Trial Acronym |
EA - ADL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hariprasath M |
| Designation |
MOT - 2nd year student |
| Affiliation |
KMCH College of Occupational Therapy |
| Address |
SF No 259 and 267 Kalapatti Post
Coimbatore 641 048 Tamil Nadu
Coimbatore
TAMIL NADU
641402
India |
| Phone |
09942791213 |
| Fax |
|
| Email |
harimprasath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
C Yamuna |
| Designation |
Professor |
| Affiliation |
KMCH College of Occupational Therapy |
| Address |
SF No 259 and 267 Kalapatti Post
Coimbatore 641 048 Tamil Nadu
Coimbatore
TAMIL NADU
641 048
India |
| Phone |
9677610885 |
| Fax |
|
| Email |
yamunachandran@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
C Yamuna |
| Designation |
Professor |
| Affiliation |
KMCH College of Occupational Therapy |
| Address |
SF No 259 and 267 Kalapatti Post
Coimbatore 641 048 Tamil Nadu
Coimbatore
TAMIL NADU
641 048
India |
| Phone |
9677610885 |
| Fax |
|
| Email |
yamunachandran@gmail.com |
|
|
Source of Monetary or Material Support
|
| KMCH College of Occupational therapy - Kalapatti post, Tamilnadu, Coimbatore - 641048 |
|
|
Primary Sponsor
|
| Name |
MrsYamuna |
| Address |
SF No 259 and 267 Kalapatti Post
Coimbatore 641 048 Tamil Nadu |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Hariprasath M |
Kovai Medical Center Hospital |
Dr Sujatha Missal 99, Avanashi Road,
Coimbatore-641014, India
Coimbatore
TAMIL NADU |
04224323731
sujatamissal@kmchhospitals.com |
| Hariprasath M |
Laakshmi Physiotherapy center - Pain clinic |
Dr G Saran 494,Trichy Road, Singanallur
Coimbatore - 641 045
Coimbatore
TAMIL NADU |
9384451981
laakshmiphysioclinic@gmail.com |
| Hariprasath M |
SULUR PHYSIO CARE |
Dr Vignesh prabu Sulur old bus stand, Thangam complex, Sulur, Tamil Nadu 641402, India
Coimbatore
TAMIL NADU |
08015246462
vickyvignesh0711@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL HUMAN ETHICS COMMITTEE KMCH INSTITUTE OF ALLIED HEALTH SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I639||Cerebral infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Error Augmentation |
Error augmentation (EA) is a relatively new concept in occupational therapy stroke rehabilitation that has shown promise in addressing common post-stroke deficits. EA utilizes false sensory feedback to improve or adapt motor learning and rehabilitation to a specific environment. It is an intervention that isolates and enhances motor errors. The amplification of errors provides feedback that promotes the correction of movement patterns and allows for changes in motor control. This type of error-driven learning is thought to be crucial to neuroplasticity and the reacquisition of skill in human movement. The importance of EA is rooted in the ability of the human nervous system to relearn and shape movements for optimal motor performance. |
| Comparator Agent |
Standard Occupational therapy |
Visual and auditory augmented feedback, followed by conventional occupational therapy intervention for ADL retraining. Physical assistance, such as manual support is also provided.
During task performance, visual support, such as allowing the patient to see or using a mirror, is provided.
Additionally, auditory guidance, including clear commands about directions and corrections for errors, is offered.
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
First onset of stroke
Medically stable patients
Clients those who are willing to participate in the study
Clients within an age group of 45 to 60
Both genders
Clients with subacute Stroke
Clients with a score of greater than or equal to 18 in MoCA
Clients in stage 4 and 5 in the Brunnstrom recovery stage
Clients with a score of 13 to 24 (moderate postural impairment) in the Postural
assessment scale for Stroke)
Cortical and subcortical stroke meeting the other criteria will be included in the study |
|
| ExclusionCriteria |
| Details |
Participants with multiple strokes, bilateral paresis, severe spasticity or contracture,
sensory deficits, cerebellar strokes resulting in ataxia, syndromes of strokes, significant
shoulder pain, and botulinum toxin injection to the hemiparetic limb.
Patients with unilateral neglect and other cognitive perceptual issues like aphasia,
apraxia, and visual perceptual deficit
Patients with visual and hearing impairment
Patient with other neurological deficits like Parkinson’s, dementia, and psychiatric
conditions. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Motor function and balance |
Motor function and balance at pretest and posttest after 4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Activities of Daily Living |
Activities of Daily Living at pretest & posttest after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "48"
Final Enrollment numbers achieved (India)="48" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
05/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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
|
Error augmentation techniques are designed to improves functional performance of hand and
balance in post stroke patients and this study will check whether these techniques help patients
with stroke to get better.
This project is about helping people who have had a stroke improve their ability to do everyday
activities and feel more confident in managing life on their own. After a stroke, many people
find it hard to do simple tasks using hand. Generally, therapy helps by practicing these tasks.
All patients in this study will receive conventional occupational performance training. One
group will receive only the conventional training, while another group will receive an
additional therapy error augmentation along with the conventional training. At the end, both
the groups will be compared to see whether error augmentation technique provided additional
benefit |