| CTRI Number |
CTRI/2023/08/056636 [Registered on: 18/08/2023] Trial Registered Prospectively |
| Last Modified On: |
25/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Establishment of normative values of Functional Reach Test’, ‘Timed Up and Go’ test, Apley’s scratch test’ and ‘Pectoralis minor muscle resting length test ’ in healthy adults in Haryana, India |
|
Scientific Title of Study
|
Establishment of normative reference values for balance and flexibility tests in heathy adults in Haryana, India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suman |
| Designation |
Assistant Professor |
| Affiliation |
Pt BD Sharma University of Health Sciences/ PGIMS Rohtak, Haryana, India |
| Address |
College of Physiotherapy,E- Block, Old OPD, Pt BD Sharma University of Health Sciences/ PGIMS, Rohtak, Haryana, India
Rohtak
HARYANA
124001
India |
| Phone |
8814063412 |
| Fax |
|
| Email |
sumanmehra2017@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suman |
| Designation |
Assistant Professor |
| Affiliation |
Pt BD Sharma University of Health Sciences/ PGIMS Rohtak, Haryana, India |
| Address |
College of Physiotherapy, E-Block, Old OPD, Pt BD Sharma University of Health Sciences/ PGIMS Rohtak, Haryana, India
HARYANA
124001
India |
| Phone |
8814063412 |
| Fax |
|
| Email |
sumanmehra2017@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Suman |
| Designation |
Assistant Professor |
| Affiliation |
Pt BD Sharma University of Health Sciences/ PGIMS Rohtak, Haryana, India |
| Address |
College of Physiotherapy, E-B lock, Old OPD, Pt BD Sharma University of Health Sciences/ PGIMS Rohtak, Haryana, India
HARYANA
124001
India |
| Phone |
8814063412 |
| Fax |
|
| Email |
sumanmehra2017@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. BD Sharma PGIMS Rohtak, Haryana |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Medical Sciences |
| Address |
PGIMS, Rohtak, Haryana, India
PIN- 124001 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Suman |
PGIMS, Rohtak |
College of Physiotherapy, E- Block, Old OPD, Pt BD Sharma PGIMS/ UHS, Rohtak
Rohtak
HARYANA |
8814063412
sumanmehra2017@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committe, PT BD Sharma PGIMS/UHS Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects with balance and flexibility impairments |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Normal healthy individuals (self‑reported, not on any medications)
2. Age - ≥18 years
3. Gender- Both males and females.
4. All subjects should present a clinical stability, defined as absence of any acute disease during 6 weeks preceding the study.
5. Subjects who have no medical condition, physical or cognitive limitation which would prohibit them from participating safely in the study.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with history of any recent upper, lower extremity or back injury/surgery.
2. Individuals with current diagnosis of any neuromuscular, musculoskeletal, respiratory, or cardiovascular problems.
3. Pregnant females
4. Subjects with history of chest pain, fainting, vertigo, or dizziness.
5. Subjects undergoing any athletic training programme.
6. Individuals with any psychiatric illness or difficulty in understanding and performing the tests
7. Subjects who refuse to give informed consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Timed Up & Go Test scores (in seconds)
2.Functional Reach Test Scores (in cm.)
3.Apley’s Back Scratch Test scores ( in cm.)
4.Pectoralis Minor muscle resting length ( in cm. ) |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="350"
Sample Size from India="350"
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)
|
27/08/2023 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Normative scores of an outcome measure from a reference population, provide information about the range of performance that can be expected of individuals at different ages, and make it possible to compare the performance of one person or group of individuals, with others of the same age and gender. Reference scores of an objective test help clinicians and researchers in differentiating the test results as ‘normal’ or ‘abnormal’, increasing its usefulness and allowing comparison and interpretability of test scores in several ways ( P J O’Connor, 1990). Although reference values of ‘Functional Reach Test’, ‘Timed Up and Go’ Test, Apley’s scratch test and pectoralis minor muscle resting length are available from western populations and few other Indian states but the normative values of these four tests have not been established in healthy Haryanvi adults. As normative values of a test are influenced by variations in genetic, environmental and nutritional factors which influence overall performance of an individual, it would be appropriate to find out the normative values of these tests in Haryanvi adults for use in Haryanvi settings specifically. The aim of this study is to establish normative values of ‘Functional Reach Test’ and ‘Timed Up and Go’ Test, ‘Apley’s scratch test’ and ‘Pectoralis minor muscle resting length’ across ages and gender groups in healthy adults in Haryana, India. Study Design- Observational study. Place Of Data Collection- PGIMS Rohtak. Study subjects- Normal healthy subjects ( male and female) , ≥18 years old. Procedure- The willing subjects will be explained about the nature of the study and will undergo a screening procedure for inclusion and exclusion criteria. Subjects who meet the inclusion criterion will be invited to participate in the study and an informed consent will be obtained. The measurements for all four tests will be obtained and analysed using appropriate statistical tests.
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