| CTRI Number |
CTRI/2024/10/075340 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
10/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Assessing fall risk in subacute stroke patients: comparing two mobility tests |
|
Scientific Title of Study
|
comparison analysis performance-oriented mobility assessment test and functional reach test as predictor falls in subacute stroke - comparative 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 |
Krupa Mori |
| Designation |
Post Graduate Student |
| Affiliation |
School of Physiortherapy, RK University |
| Address |
Research Department, Room no. 207, School of Physiortherapy, RK
University kasturbadham Rajkot-Bhavnagar Highway, Rajkot,
Gujarat, India.
Rajkot
GUJARAT
360020
India
Rajkot
GUJARAT
360020
India |
| Phone |
9104487457 |
| Fax |
|
| Email |
kmori998@rku.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shirkant savaniya PT MPT |
| Designation |
Assistant Professor |
| Affiliation |
School of Physiortherapy, RK University |
| Address |
Research Department, Room no. 207, School of Physiortherapy, RK
University kasturbadham Rajkot-Bhavnagar Highway, Rajkot,
Gujarat, India.
Rajkot
GUJARAT
360020
India
Rajkot
GUJARAT
360020
India |
| Phone |
8980748154 |
| Fax |
|
| Email |
shrikant.savaniya@rku.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shirkant savaniya PT MPT |
| Designation |
Assistant Professor |
| Affiliation |
School of Physiortherapy, RK University |
| Address |
Research Department, Room no. 207, School of Physiortherapy, RK
University kasturbadham Rajkot-Bhavnagar Highway, Rajkot,
Gujarat, India.
Rajkot
GUJARAT
360020
India
Rajkot
GUJARAT
360020
India |
| Phone |
8980748154 |
| Fax |
|
| Email |
shrikant.savaniya@rku.ac.in |
|
|
Source of Monetary or Material Support
|
| Research Department, Room no. 207, School of Physiortherapy, RK
University kasturbadham Rajkot-Bhavnagar Highway, Rajkot,
Gujarat, India.
360020
|
|
|
Primary Sponsor
|
| Name |
Krupa Mori |
| Address |
Research Department, Room no. 207, School of Physiortherapy, RK
University kasturbadham Rajkot-Bhavnagar Highway, Rajkot,
Gujarat, India.
360020
|
| Type of Sponsor |
Other [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 Krupa Mori |
RK Physiotherapy Rehabilitation and Research center |
Physiotherapy
Department, Room no.
1, opp Meghani rang
bhuvan,Bhaktinagar
circle Rajkot, Gujarat,
India.
Rajkot
GUJARAT |
9104487457
kmori998@rku.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, School of Physiotherapy, RK University, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G938||Other specified disorders of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Functional Reach Test |
The functional reach test is a single item test developed as a quick screen for balance problems in older adult. A score for 6 or less indicates a significant increased risk falls. A score between 6-10inches indicated a moderate risk for falls |
| Intervention |
Performance Oriented Mobility Assessment (POMA) test |
Performance oriented mobility assessment test is a widely used instrument that provided an evaluation of balance gait . In Performance oriented mobility assessment test balance component is 9 or gait is 7 means total component is 16 . A score between less than 19 indicated high fall risk 19-24 indicated medium fall risk 25-28 indicated low fall risk . |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with stroke within the past 6 month
Able to follow simple instruction
Ambulatory with or without a walking aids
No severe cognitive impairments
Constant patient included
|
|
| ExclusionCriteria |
| Details |
Severe aphasia or communication disorders
Orthopedic condition affecting mobility (severe arthritis, recent fractures )
Severe visual and auditory impairment
Not constant patient not included
Sensory examination
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Tinetti performance oriented mobility assessment (POMA)
Functional reach test (FRT)
|
Tinetti performance oriented mobility assessment (POMA)
Functional reach test (FRT)
|
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
28/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/10/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Title of study : COMPARISON ANALYSIS PERFORMANCE ORIENTED MOBILITY ASSESSMENT TEST AND FUNCTIONAL REACH TEST IN PREDICTING FALLS IN SUBACUTE STROKE- A COMPARATIVE STUDY. Subacute stroke refers to the phase stroke recovery that follow the acute stage, typically starting around one to two weeks after the initial stroke. During this period, the brain begins to heal, and symptoms may improve gradually.
This period follow the acute phase (the first few days post-stroke) and precedes the chronic phase (beyond one month). Falls are common in the subacute stroke and frequently have serious consequences, which leads to physical and psychological complication. Almost one third of people more than the age of 60 suffer from falls at a least once a year .This is one of the major health problems. The consequences of a fall can ranges from minor injuries to death , putting a financial strain on people, the health care system . Need of study : This study is needed to determine if the functional reach test and performance oriented mobility Assessment test (POMA) provide complementary insights for accurately predicting falls in subacute stroke patients, which can enhance screening , optimize rehabilitation , and improve resource allocation .
|