| CTRI Number |
CTRI/2024/04/064951 [Registered on: 01/04/2024] Trial Registered Prospectively |
| Last Modified On: |
27/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Visual feedback training and task specific balance training for pushers syndrome |
|
Scientific Title of Study
|
Effectiveness of Task Specific Training with Visual Feedback Training and Visual Feedback Training Alone in Improving Pushers Behaviour in Pushers Syndrome |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KARUNYA K |
| Designation |
MPT NEUROLOGY STUDENT |
| Affiliation |
Sri Ramakrishna Institute of Paramedical Sciences |
| Address |
Sri Ramakrishna Institute of Paramedical Sciences Room No 4017 Division of Neurology Department of Physiotherapy #395 Sarojini Naidu Road Siddhapudur Coimbatore
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9943720956 |
| Fax |
|
| Email |
karukalimuthu16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof R Porkodi |
| Designation |
Professor |
| Affiliation |
Sri Ramakrishna Institute of Paramedical Sciences |
| Address |
Sri Ramakrishna Institute of Paramedical Sciences Department of Physiotherapy Neurological Division Room No 4016 #395 Sarojini Naidu Road Siddhapudur Coimbatore
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9443820164 |
| Fax |
|
| Email |
porkodi.mpt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof R Porkodi |
| Designation |
Professor |
| Affiliation |
Sri Ramakrishna Institute of Paramedical Sciences |
| Address |
Sri Ramakrishna Institute of Paramedical Sciences Department of Physiotherapy Neurological Division Room No 4016 #395 Sarojini Naidu Road Siddhapudur Coimbatore
TAMIL NADU
641044
India |
| Phone |
9443820164 |
| Fax |
|
| Email |
porkodi.mpt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramakrishna Institute of Paramedical Sciences Room No 4017 Division of Neurology Department of Physiotherapy #395 Sarojini Naidu Road Siddhapudur Coimbatore |
|
|
Primary Sponsor
|
| Name |
KARUNYA K |
| Address |
Sri Ramakrishna Institute of Paramedical Sciences #395 Sarojini Naidu Road Siddhapudur Coimbatore |
| Type of Sponsor |
Other [other self (part of master program)] |
|
|
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 |
| KARUNYA K |
Sri Ramakrishna Multispeciality Hospital |
Sri Ramakrishna Institute of Paramedical Sciences Room No 4017 Division of Physiotherapy Department of Physiotherapy #395 Sarajininaidu Road Siddhapudur
Coimbatore
TAMIL NADU |
9943720956
karukalimuthu16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI RAMAKRISHNA HOSPITAL ETHICAL COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I698||Sequelae of other cerebrovasculardiseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Task Specific Training and Visual Feedback Training |
Daily For 40 Minutes For 4 Weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Hemiparesis voluntary control grading 1 to 5
Ischaemic and haemorrhagic thalamic stroke
Sub acute stage of stroke
First episode of stroke
Underwent scale for contraversive pushing
Able to understand and exhibit the commands cognition level MMSE more than 25
MCA and PCA stroke
Patient with static balance
Subjects with pain
|
|
| ExclusionCriteria |
| Details |
Bilateral involvement
Visual and auditory impairment
Any other severe muscular or neurological
impairment in non paretic side
Multiple infarct
Hemineglect subjects
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pushers behaviour |
At baseline and at end of 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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 3 |
|
Date of First Enrollment (India)
|
06/04/2024 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
EFFECTIVENESS OF TASK SPECIFIC TRAINING WITH VISUAL FEEDBACK TRAINING AND VISUAL FEEDBACK TRAINING ALONE IN IMPROVING PUSHERS BEHAVIOUR IN PUSHERS SYNDROME
BACKGROUND: · Stroke is becoming an important cause of premature death and disability in low income and middle income countries like India. The evidence is consistent that there are longer recovery times in hemiparetic patients with PS than in those without the condition, around 3–6 additional weeks of recovery to reach the same functional level , and symptoms can persist till 6-8 months, which results in delayed functional and motor recovery than in non-pushers. NEED OF THE STUDY: It is evident that pushers syndrome affects the time of recovery after stroke So the need of this study is to find the difference in effect of TSBT with andwithout VFB training in correcting the pushers behaviour and its impact in improving the speed of recovery in stroke. OBJECTIVE OF THE STUDY: The main objective is to see the effect of TSBT when given along with VFB training for treating pushers behaviour and treating with VFB training alone. METHODOLOGY: TSBT AND VFB GROUP : Visual feedback training for 20 mins along with task specific balance training for 20 mins /day. VFB GROUP : Visual feedback training for 20 mins/day. KEYWORDS: PUSHERS SYNDROME , PUSHERS BEHAVIOUR , TASK SPECIFIC TRAINING , VISUAL FEEDBACK TRAINING
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