| CTRI Number |
CTRI/2021/05/033513 [Registered on: 10/05/2021] Trial Registered Prospectively |
| Last Modified On: |
10/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison between 2 dual tasking tests to see which one better predicts risk of falls in stroke patients |
|
Scientific Title of Study
|
Walking-While-Talking Test versus Stops-Walking-When- Talking Test on predicting risk of falls in stroke survivors |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Disha Lamba |
| Designation |
Post-graduate Student |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Physiotherapy,
KMC Hospital,
Jyoti Circle,
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8779093957 |
| Fax |
|
| Email |
dishalamba12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abraham M Joshua |
| Designation |
Associate Professor (Senior Scale) |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Physiotherapy,
KMC Hospital,
Jyoti Circle,
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9886188221 |
| Fax |
|
| Email |
abraham.joshua@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Disha Lamba |
| Designation |
Post-graduate Student |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Physiotherapy,
KMC Hospital,
Jyoti Circle,
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8779093957 |
| Fax |
|
| Email |
dishalamba12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College,
Department of Physiotherapy,
Centre of Basic Sciences,
Bejai,
Mangalore-575004.
Karnataka |
|
|
Primary Sponsor
|
| Name |
Manipal University |
| Address |
Light House,
Hill Road,
Mangalore-575001 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Disha Lamba |
KMC, Mangalore |
Department of Physiotherapy,
7th Floor,
KMC Hospital,
Jyoti Circle,
Mangalore
Dakshina Kannada
KARNATAKA |
8779093957
dishalamba12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Medical College, Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G89-G99||Other disorders of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
Respected Sir/Maam,
This study is a single group, observational study to check the efficacy of 2 qualitative tools in identifying cognitive-motor interactions in independently ambulating stroke patients. It is a cross sectional study in which the ability of the participants to dual task will be observed. There are already existing studies on dual tasking in Parkinsons Disease and the current study is being undertaken to observe cognitive-motor interactions in Stroke patients. In the above ‘TYPE’ drop down box, I did not have an option hence I have chosen comparator agent. I request you to kindly note that my study is an observational study and not a clinical trial so it is my humble request to you to kindly do the needful.
Walking While Talking Test-
Individuals are supposed to walk 20 feet, turn and return back 20 feet while reciting alphabets loudly. Scoring is based on time taken to complete the test.
https://www.sralab.org/rehabilitation-measures/walking-while-talking-test
Stops Walking When Talking Test-
The individual is asked to walk at his/her own pace and the examiner walks just behind him. The examiner then initiates a conversation with the patient while continuing to walk. The test is positive if the patient stops walking while trying to reply to the conversation.
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
First episode of stroke
Clinically stable patient
MOCA Score-26 and above
Any ambulatory stroke survivor
|
|
| ExclusionCriteria |
| Details |
Patients with any visual impairments.
Patients with any other neurological conditions.
Patients with any musculoskeletal disorders.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Berg Balance Scale
Falls Efficacy Questionnaire
|
One time measurement at the time of recruitment |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Risk of Falls |
Baseline |
|
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Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "68"
Final Enrollment numbers achieved (India)="68" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/05/2021 |
| Date of Study Completion (India) |
16/05/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Independently ambulating stroke patients will be selected for
the study.
Each
subject will be assessed using 3 fall prediction tools i.e. Berg Balance Scale, Walking While Talking Test, Stops Walking When
Talking Test and 1 questionnaire-Falls Efficacy Questionnaire. The assessment will be conducted as per the standard procedure
which involves randomly assigning the 3 tests and 1 questionnaire to each
patient. The tests shall be administered with 5 minute rest periods in between.
Throughout the procedure, for safety purpose, manual assistance/support will be
provided by 2 physiotherapists by staying in close proximity to the patient.
•
Berg Balance Scale: Scores will be given
according to the criteria described by Berg et al.
•
Falls Efficacy Scale: A questionnaire
will be handed to the patient to fill and scoring will be given by the tester
using the criteria described by Tinetti et al.
•
Walking While Talking Test: The scoring
will be time based.
•
Stops Walking When Talking Test: The test
would be considered positive if patient stops walking when the evaluator
initiates a conversation. |