| CTRI Number |
CTRI/2025/02/081369 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
effect of trunk taping on walking and balance among patients with acute stroke |
|
Scientific Title of Study
|
Immediate Effect of Trunk Kinesio Taping on Balance And Mobility among patients with Acute Stroke: A Quasi Experimental Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Guru Dayal |
| Designation |
student |
| Affiliation |
School of Health Sciences Chhatrapati Shahuji Maharaj University |
| Address |
School of Health Sciences
Department of Physiotherapy SHS 106
CSJMU Kanpur
Kanpur Nagar
UTTAR PRADESH
208024
India
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
7398606869 |
| Fax |
|
| Email |
gurudayaljnp007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Adarsh Kumar Srivastav |
| Designation |
Assistant Professor |
| Affiliation |
School of Health Sciences Chhatrapati Shahuji Maharaj University |
| Address |
School of Health Sciences
Department of Physiotherapy SHS 106
CSJMU Kanpur
Kanpur Nagar
UTTAR PRADESH
208024
India
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
8618889003 |
| Fax |
|
| Email |
adarshkumarsrivastava@csjmu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Adarsh Kumar Srivastav |
| Designation |
Assistant Professor |
| Affiliation |
School of Health Sciences Chhatrapati Shahuji Maharaj University |
| Address |
School of Health Sciences
Department of Physiotherapy SHS 106
CSJMU Kanpur
Kanpur Nagar
UTTAR PRADESH
208024
India
UTTAR PRADESH
208024
India |
| Phone |
8618889003 |
| Fax |
|
| Email |
adarshkumarsrivastava@csjmu.ac.in |
|
|
Source of Monetary or Material Support
|
| School of Health Sciences, Department of Physiotherapy SHS 106 CSJMU Kanpur Kanpur
Nagar UTTAR PRADESH 208024 India
|
|
|
Primary Sponsor
|
| Name |
School of Health Sciences chhatrapati Shahuji Maharaj University |
| Address |
School of Health Sciences, Department of Physiotherapy SHS 106 CSJMU Kanpur Kanpur
Nagar UTTAR PRADESH 208024 India
|
| Type of Sponsor |
Research institution |
|
|
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 Adarsh Kumar Srivastav |
SCHOOL OF HEALTH SCIENCES PHYSIOTHERAPY OPD |
School of Health
Sciences Department of
Physiotherapy
Physiotherapy OPD
SHS 106 CSJMU
Kalyanpur
Kanpur Nagar
UTTAR PRADESH
Kanpur Nagar
UTTAR PRADESH |
8618889003
adarshkumarsrivastava@csjmu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Ethical Committee,CSJMU Kanpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G811||Spastic hemiplegia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Trunk Kinesio taping |
kinesio taping will be applied on 3 muscles which are erector spinae, transversus abdominis and rectus abdominis. 3 I shaped strips will be taken and applied from insertion to origin with 25% tension. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Mild Acute/Subacute ischemic or hemorrhagic stroke
duration of stroke less tahn 6 months
mini mental state examination score greater than 20
signed informed consent
ability to stand for atleast 30 sec |
|
| ExclusionCriteria |
| Details |
history of allergy to kinesio taping
musculoskeletal disorder
age above 66 year
lower extremity surgery or fracture
any cognitive and perceptual disorder
seizure |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Berg Balance Scale
10 metre walk test |
immediately after applying |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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)
|
31/03/2025 |
| 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="0"
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
|
Introduction- stroke is a neurological disease which occurs due to
reduced blood supply to the brain. Acute stroke is defined as stroke
within 48 hours. Rehabilitation can be started as soon as initial
symptoms of the patients is stabilized. Hemiplegia is considered
hallmark of the disease. Truncal weakness is considered one of the main
reasons for deficits in mobility and balance. Kinesio taping is the novel
method for re education of truncal weakness among patients with acute
stroke. Objective of this study will be to identify the effects of trunk
kinesio taping on balance and mobility among patients with acute stroke.
Hypothesis of this study will be that trunk kinesio taping will improve
balance and mobility among patients with acute stroke.
Methods- Sample size was calculated using G power software. 16
participants will be included in this study after screening for selection
criteria. Data will be assessed immediately before and after applying
kinesio tape. Balance will be asseed using berg balance scale and
mobility will be assessed using 10 metre walk test. Data will be analyzed
using SPSS software and the results of this study will be published.
Results- The results of this study will provide insights into acute
neurorehabilitation of patients presenting with acute stroke. |