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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I679||Cerebrovascular disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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.

 
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