| CTRI Number |
CTRI/2022/09/045300 [Registered on: 07/09/2022] Trial Registered Prospectively |
| Last Modified On: |
06/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Non target and target oriented functional reach in elderly persons |
|
Scientific Title of Study
|
To Analyse difference between Non target and Target oriented functional reach among elderly population |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sangeetha B |
| Designation |
Student |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
No 6 VOC Nagar Extension,
Peethambaram Complex Phase-II, Sathuvachari,
Vellore. Faculty Of Physiotherapy
Sri Ramachandra Institute Of Higher Education And Research
Porur
CHENNAI-600116. Chennai TAMIL NADU 632009 India |
| Phone |
9894480896 |
| Fax |
|
| Email |
t0320003@sriramachandra.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Radhika CM |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
Faculty Of Physiotherapy,
Sri Ramachandra Institute Of Higher Education And Research,
Porur,
Chennai.
Chennai TAMIL NADU 600116 India |
| Phone |
9841376961 |
| Fax |
|
| Email |
radhikacm@sriramachandra.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Radhika CM |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
Faculty Of Physiotherapy,
Sri Ramachandra Institute Of Higher Education And Research,
PORUR,
CHENNAI.
Chennai TAMIL NADU 600116 India |
| Phone |
9841376961 |
| Fax |
|
| Email |
radhikacm@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| faculty of physiotherapy
sri ramachandra institute of higher education and research |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [nil] |
|
|
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 |
| SANGEETHA B |
Faculty Of Physiotherapy |
Faculty Of Physiotherapy (Outpatient department),
Sri Ramachandra Institute Of Higher Education And Research,
PORUR,
CHENNAI -600116 Chennai TAMIL NADU |
9894480896
t0320003@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ELDERLY POPULATION |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NL |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Both male and female 65 years and above
Asymptomatic individuals
Subject lining in community who can ambulate with or without walking aids
Shoulder flexion and abduction within the range and ankle dorsiflexion range present which doesn’t affect the test.
Subject should stand independently for atleast 30 seconds
|
|
| ExclusionCriteria |
| Details |
Subject with severe musculoskeletal conditions requiring active management
Neurological disorders such as stroke, brain injury, multiple sclerosis, peripheral neuropathy, vertigo and whiplash injury.
Blindness and deafness
Cardio-respiratory disorder
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Fall efficacy scale
Forward reach test
Target-oriented forward reach
Lateral reach test
Target-oriented lateral reach |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="124" Sample Size from India="124"
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)
|
12/09/2022 |
| 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="1" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aging
is often accompanied by decreased muscle strength, aerobic capacity, balance
and gait which can lead to impaired physical performance and experience
difficulty in the activities of daily living (ADL). Balance is maintained by
interaction between Visual, vestibular and proprioceptive, thus involvement of
any one of these systems can cause balance impairment. If balance is affected
then it will also affect the flexibility. Measurement of balance is an
important component of balance rehabilitation, both static and dynamic balance
abilities are considered integral parts of flexibility skills. The Functional
Reach Test (FRT) and Lateral Reach Test (LRT) are two commonly used tools that measure
dynamic balance. The Functional Reach Test evaluates the forward stability of a standing
subject who voluntarily extends one arm as far forward as possible in the
horizontal plane, while keeping both heels in contact with the ground. The
score is obtained by measuring the distance between fingertips’s starting and
end position. The FRT score correlates with the
anteroposterior excursion of the centre of pressure (CoP). The FRT has
demonstrated good test-retest and inter rater reliability, and it can predict
community-dwelling older adults who are at a high risk for falling, which is a
marker of frailty and functional dependency.
The lateral reach
test measures lateral postural stability by assessing the maximum distance an
individual can reach laterally while standing in a fixed position. The test is
correlated with center of pressure excursion and has high test-retest
reliability, thereby supporting its use as a clinical indicator of
medial-lateral postural stability and its use as an indicator of risk of
falling.
A task similar to
functional reach and lateral reach is incorporated that is to reach a target
among the elderly subjects in order to find the difference. A major difference
compared to reaching task is to reach for a target object. The
test was considered successfully completed when the subject grasped the
circumference of the object and reached the target of the object returned to an upright standing position. The maximum distance achieved by the subject beyond
his/her FR score was recorded as the target-oriented functional reach score.
It would seem that
the task of Functional Reach, lateral reach and the task of reaching on
targeted object would likely produce different quantitative results since they
are not identical tasks.
This study is done
to analyse difference between non target and target oriented functional reach
among elderly population with and without fear of fall. Ag |