| CTRI Number |
CTRI/2022/02/040242 [Registered on: 11/02/2022] Trial Registered Prospectively |
| Last Modified On: |
09/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Correlational Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare relationship of unilateral neglect with balance and gait among sub acute stroke survivors |
|
Scientific Title of Study
|
Relationship between Balance, Gait and Unilateral Neglect in Sub-Acute Stroke Patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashna Sinha |
| Designation |
PG student (Masters of Physiotherapy) |
| Affiliation |
Amity Institute of Physiotherapy |
| Address |
Block F1, Amity Institute of Physiotherapy, Amity University, Noida- Sector 125.
Gautam Buddha Nagar UTTAR PRADESH 201301 India |
| Phone |
8860117958 |
| Fax |
|
| Email |
ashnasnh15@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Meena Gupta |
| Designation |
Assisstant Professor |
| Affiliation |
Amity Institute of Physiotherapy |
| Address |
Block F1, Amity Institute of Physiotherapy, Amity University, Noida- Sector 125. Block F1, Amity Institute of Physiotherapy, Amity University, Noida- Sector 125. Gautam Buddha Nagar UTTAR PRADESH 201301 India |
| Phone |
9717281491 |
| Fax |
0 |
| Email |
mgupta9@amity.edu |
|
Details of Contact Person Public Query
|
| Name |
Ashna Sinha |
| Designation |
PG student (Masters of Physiotherapy) |
| Affiliation |
Amity Institute of Physiotherapy |
| Address |
Block F1, Amity Institute of Physiotherapy, Amity University, Noida- Sector 125.
UTTAR PRADESH 201301 India |
| Phone |
8860117958 |
| Fax |
|
| Email |
ashnasnh15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vimhans Nayati Super-Speciality Hospital, 1, Institutional Area, Nehru Nagar, Lajpat Nagar, New Delhi, Delhi 110065 |
|
|
Primary Sponsor
|
| Name |
Ashna Sinha |
| Address |
Block F1, Amity Institute of Physiotherapy, Amity University, Noida- Sector 125 |
| 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 |
| Dr Prateek Gaur PT |
Vimhans Nayati Super Speciality Hospital |
Physiotherapy Department,1, Institutional Area, Nehru Nagar, Lajpat Nagar, New Delhi, Delhi 110065 South DELHI |
9891304886
prateek.physiotherapist@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amity Institute of Physiotherapy (NTCC Commitee) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I679||Cerebrovascular disease, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Age between 40-70 years
2)Male & female population
3)Definitive diagnosis of stroke
4)Stroke duration of 3 weeks - 6 months
5)Unilateral neglect |
|
| ExclusionCriteria |
| Details |
Participants who had a diagnosis of dementia prior to stroke
Visual impairment (including homonymous hemianopsia)
Hearing impairment
Bilateral hemiparesis
Cerebellar and brain stem lesions
Unstable neurological conditions like seizures
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Catherine Bergego Scale.
Berg Balance Scale,
10 Meter Walk Test. |
One time ( At the time of data collection) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
13/02/2022 |
| 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="2" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Waiting for CTRI approval |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
30
stroke patients will be selected for the study based upon the inclusion
criteria. The screening tool used for assessing unilateral neglect is
Catherine Bergego
Scale (CBS). So those subjects who will have BIT
score
≥ 1 will
be put in Group 1 (stroke patients with unilateral neglect).
The remaining subjects with CBS
score
=
0 will be allotted group 2 (stroke
patients without unilateral neglect).
Catherine
Bergego Scale (CBS) is
a checklist for therapists designed to assess the presence and severity of
unilateral spatial neglect in a range of daily activities. Neglect behavior is
rated by the observer on a 4-point scale: absent (0), mild (1), moderate (2)
& severe (3). The average score for all rated items is multiplied by 10 to
produce a total score ranging from 0 to 30. Ratings of neglect severity
according to total scores is 0 = No behavioral neglect, 1-10 = Mild behavioral
neglect, 11-20 = Moderate behavioral neglect and 21-30 = Severe behavioral
neglect.
Now,
in both the groups balance and gait will be assessed. Balance
will be assessed by Berg Balance Scale (BBS). Gait will be assessed by 10-M
Walk Test. The scores for balance and gait will be analyzed and then we will
find out the correlation of unilateral neglect with balance and gait in
sub-acute stroke patients. If unilateral neglect will show positive correlation
with the balance and gait, then hypothesis for this study will be true. |