| CTRI Number |
CTRI/2024/02/063270 [Registered on: 28/02/2024] Trial Registered Prospectively |
| Last Modified On: |
05/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
L test and its ability to check mobility and turning ability among patients with stroke. |
|
Scientific Title of Study
|
Relationship of L test in assessing functional mobility and turning ability among stroke patients with different levels of functional ambulation. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vedika Rege |
| Designation |
Student |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Physiotherapy, Kasturba Medical college, Mangalore, Center for Basic Sciences, Bejai, Mangalore, 575004
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
7588275305 |
| Fax |
|
| Email |
vedika.mchpmlr2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Akshatha Nayak |
| Designation |
Assistant professor- selection grade |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Physiotherapy, Kasturba Medical college, Mangalore, Center for Basic Sciences, Bejai, Mangalore, 575004
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9986054034 |
| Fax |
|
| Email |
akshatha.nd@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Akshatha Nayak |
| Designation |
Assistant professor- selection grade |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Physiotherapy, Kasturba Medical college, Mangalore, Center for Basic Sciences, Bejai, Mangalore, 575004
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9986054034 |
| Fax |
|
| Email |
akshatha.nd@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Mangalore |
|
|
Primary Sponsor
|
| Name |
Vedika Rege |
| Address |
Department of Physiotherapy, Kasturba Medical college, Mangalore, Center for Basic Sciences, Bejai, Mangalore - 575004 |
| Type of Sponsor |
Other [Self funded] |
|
|
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 |
| Vedika Rege |
Kasturba Medical College Hospital |
Department of Physiotherapy, KMC Hospital, Attavara, Mangalore
Department of Physiotherapy, KMC Hopsital, Ambedkar Circle, Mangalore.
Dakshina Kannada
KARNATAKA |
7588275305
vedika.mchpmlr2023@learner.manipal.edu |
|
|
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: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Clinically stable patients suffered from 1st episode of supratentorial stroke in preceding 6 months.
2.Stroke patients above 18 years of age.
3.Ability to walk 20 meters distance independently with or without walking aid.
4.Functional Ambulation Category grade ≥ 3
5.MOCA score ≥ 26
|
|
| ExclusionCriteria |
| Details |
1.Co-existing neurological or orthopedic conditions that may cause difficulty in ambulation.
2.Visual, auditory or cognitive impairments affecting patient’s ability to complete the test.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| L Test duration |
0-6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Timed UP & go test |
0-6 months |
| Mini- Balance Evaluation System Test |
0-6 months |
| Falls Efficacy scale |
0-6 months |
| Activity-specific balance confidence scale |
0-6 months |
| Functional Ambulation Category |
0-6 Months |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
01/03/2024 |
| 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="1"
Months="2"
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
|
The study titled ’Relationship of L test in assessing functional mobility and turning ability among stroke patients with different levels of functional ambulation’ will assess ability to safely walk and turn among acute and subacute stroke patients having different levels of functional independence. The results obtained will be correlated with the findings of gold standard outcome measures like Timed up & go test, Mini-balance evaluation system test, falls efficacy scale, Activity-specific balance confidence scale. If the study finds significant correlation between L test and gold standard outcome measures, it will allow us to incorporate L test among stroke patients in early phase of recovery. It will provide insights
about use of L test in assessing patient’s balance and risk of fall.
|