| CTRI Number |
CTRI/2025/07/091227 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
19/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A trail to compare the efficacy of clock turn strategy versus dynamic balance training on balance and fall in geriatric population. |
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Scientific Title of Study
|
Effectiveness of Clock Turn Strategy On Balance And Fall In Geriatric Population
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| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shyni M |
| Designation |
Associate professor |
| Affiliation |
Kerala University Of Health Sciences |
| Address |
School of Medical Education
Centre For Professional And Advanced Studies
Kottayam Kerala
Kottayam KERALA 686008 India |
| Phone |
8921079405 |
| Fax |
|
| Email |
sanahana12@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sandhiya M |
| Designation |
Assisstant professor |
| Affiliation |
Vels University VISTAS |
| Address |
School of Physiotherapy
Vels University VISTAS
Pallavaram Chennai
Tamil Nadu School of Physiotherapy
Vels University VISTAS
Pallavaram Chennai
Tamil Nadu Chennai TAMIL NADU 600117 India |
| Phone |
9940583928 |
| Fax |
|
| Email |
sandhiya.sp@vistas.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr. Prof. Harish Kumar K.S |
| Designation |
Professor |
| Affiliation |
Kerala University Of Health Sciences |
| Address |
School of Medical Education
Centre For Professional And Advanced Studies
Kottayam Kerala
KERALA 686008 India |
| Phone |
9447265198 |
| Fax |
|
| Email |
drharishkumarks@gmail.com |
|
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Source of Monetary or Material Support
|
| Great Jubilee Memorial, Alphonsa Abhaya Bhavan, Alphonsapuram,
Arpookara East PO, Kottayam – 686008, Kerala
|
|
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Primary Sponsor
|
| Name |
Shyni M |
| Address |
School Of Medical Education
Centre For Professional And Advanced Studies
Kottayam 686008
Kerala |
| Type of Sponsor |
Other [SELF ] |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shyni M |
Great Jubilee Memorial Alphonsa Abhaya Bhavan |
Geriatric Rehabilitation Centre
Arpookara PO
Kottayam 686008 Kottayam KERALA |
8921079405
sanahana12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| School Of Medical Education Kottayam Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z878||Personal history of other specified conditions, |
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CLOCK TURN STRATEGY ALONG WITH BALANCE STRENGTH TRAINING |
EXPERIMENTAL GROUP (GROUP A)
WARM UP EXERCISES: (5 MINUTES)
a.Neck side
b.Neck rotation
c.Arm circles
d.Trunk twisting (2
e.Marching and walking for 5 seconds
BALANCE STRENGTH TRAINING (BST) (12 MINUTES)
1.BALANCE EXERCISES:
a.Single- Leg Stance (2 sets) Stand on one leg Eye open and eye closed.
b.Foam Pad (2 sets, 30 seconds) Stand on Foam pad with eye open . and closed.
2. STRENGTH TRAINING EXERCISES:
Upper extremity:
a.Arm Raises (2 sets)
b.Shoulder Presses (2sets)
Lower Extremity:
a.Squats (2 sets)
b.Seated Marching (2 sets)
3. CORE:
a.Bridge ( 2 sets)
b.Seated Leg Press (2 set)
CLOCK TURN STRATEGY (CTS): (12 minutes)
The participants perform 180 degrees turn into two parts first from 12 to 3 O’clock and then from 3 to 6 O’clock in clock wise and then back from 6 O’clock to 3 O’ clock then to 12 in anti-clock-wise direction. Anti-clock-wise direction from 12 to 9 O’clock and then from 9 to 6 O’clock from there back to 9 O clock and then to 12 O’clock in clock wise direction.
PROCEDURE OF CLOCK TURN STRATEGY:
The patient will be asked to stand at a point, a circle will be drawn and reading and foot print will be calibrated on the circle similar to a clock. The patient will be asked to stand in the circle where 12 is indicated. The reading will be 12, 3, 6, and 9 similar to a clock. The participants perform 180 degrees turn into two parts first from 12 to 3 O’clock and then from 3 to 6 O’clock and then back from 6 O’clock to 3 O’ clock, from 3 to 12 which would take around 2 minutes to be completed. A 2-minute rest will be given to the patient and he will be allowed to rest and take water if required. After this the patient will have to begin again from 12 in an anti-clockwise direction, 12 to 9 O’clock and then from 9 to 6 from there back to 9 and then to 12 O’clock which will again take 2 minutes for the process to complete. Patient has to repeat 2 sets in clock wise and 2 sets in anti- clock direction. As done earlier a cool down period of 2 minutes will be given. The patient will be asked for any difficulties or suggestions. The total period will be for 12 minutes
COOL- DOWN: (5 MINUTES)
1.Static stretches for core muscles, Hamstrings, quadriceps.
2. Deep breathing Exercises
|
| Comparator Agent |
DYNAMIC BALANCE TRAINING ALONG WITH BALANCE STRENGTH TRAINING |
CONTROL GROUP(GROUP B)
which starts with
WARM UP EXERCISES: (5 MINUTES) a.Neck side b.Neck rotation c.Arm circles d.Trunk twisting (2 e.Marching and walking for 5 seconds BALANCE STRENGTH TRAINING (BST) (12 MINUTES) 1.BALANCE EXERCISES: a.Single- Leg Stance (2 sets) Stand on one leg Eye open and eye closed. b.Foam Pad (2 sets, 30 seconds) Stand on Foam pad with eye open . and closed. 2. STRENGTH TRAINING EXERCISES: Upper extremity: a.Arm Raises (2 sets) b.Shoulder Presses (2sets) Lower Extremity: a.Squats (2 sets) b.Seated Marching (2 sets) 3. CORE: a.Bridge ( 2 sets) b.Seated Leg Press (2 set)
DYNAMIC BALANCE TRAINING: (12 MINUTES)
1. Dynamic standing (2 sets, 30 seconds stand with feet together, shoulder . . width apart Shift weight from one leg to the other.
2. Obstacles course walking (2 sets, 10 steps, Navigate through small
Obstacles, change direction slowly.
3. Balance Reaches (2 sets, stand with feet shoulder width
apart reach for objects in different directions.
COOL- DOWN: (5 MINUTES)
a.Static stretches for core muscles, Hamstrings, quadriceps
b. Deep breathing Exercises
|
|
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Inclusion Criteria
|
| Age From |
65.00 Day(s) |
| Age To |
95.00 Day(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA
Ambulatory elderly men and women aged 65 years to 95 years.
History of falls reported by the geriatric rehabilitation centre in the past 12 months.
Physical ability to participate in a balance training program.
Patients with Body Mass Index (BMI) ranges from normal to overweight (18.5-29.9).
Patients who exhibit Skin and Soft tissue assessments documented in Physical
Examination section of the Geriatric assessment form.
Patients who have fulfilled the palpation session of the Geriatric assessment form.
Patient with mild pain as per Numerical pain rating scale score (1-3) in any
location as documented on the body pain chart.
Patients with normal sensation and reflexes, as documented in the examination session
of the Geriatric assessment form.
Patients with a functional range of motion in the upper and lower limbs or mild
limitations not significantly impacting mobility and balance exercises.
Patients with Hand grip strength and lower extremity strength ( grade 3 or higher as per
MMT) documented in the Geriatric assessment.
Muscle tone Modified Ashworth scale (MAS) score 0-2 in upper and lower limbs.
Abbreviated Mental Test Score (AMTS) 7-8/10 indicates mild cognitive impairment.
Patients who have completed a satisfactory risk factor assessment documented in
Geriatric assessment form.
Experiencing activity limitations and restrictions related to IADL Scores within 5 to 8.
Selected patients with a home safety assessment checklist indicating YES(home safety measures are provided) or N/A ( not applicable).
Medically stable patients who satisfy all the geriatric assessment criteria outlined in the Comprehensive Geriatric Assessment form will be included in the study.
Able to understand and respond effectively in the language used for the assessment and study.
Subjects willing to participate in the study by providing informed consent.
Co- operative patients with controlled health conditions.
|
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| ExclusionCriteria |
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
A. Berg Balance Scale (BBS)
B. Timed Up and Go Test (TUG)
D. Functional reach scale FRT)
E. Falls Risk Assessment Tool(FRAT)
|
Treatment is administered thrice a week on alternate days for a period of 08 weeks and total of 24 sessions both for experimental (group –A) and Control (group B).
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the effectiveness of clock turn strategy along with Balance strength training in enhancing balance in geriatric population.
To assess the effectiveness of Dynamic Balance Training along with Balance Strength Training in enhancing balance in geriatric population.
To identify the effect of Clock Turn Strategy along with Balance Strength Training in reducing falls among geriatric population
To identify the effect of Dynamic Balance Training along with Balance Strength Training in reducing falls among geriatric population.
|
Treatment is administered thrice a week on alternate days for a period of 08 weeks & total of 24 sessions both for experimental (group –A) & Control (group B).
|
|
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Target Sample Size
|
Total Sample Size="6" Sample Size from India="6"
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)
|
01/08/2025 |
| 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="2" Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
METHOD OF DATA COLLECTION
The study
is planned to be conducted in Geriatric
Rehabilitation Centre - GREAT
JUBILEE MEMORIAL, ALPHONSA ABHAYA BHAVAN, ALPHONSAPURAM, ARPOOKARA EAST PO,
KOTTAYAM – 686008, KERALA. After receiving ethical committee
consent, consent has to be obtained from the Geriatric Rehabilitation Centre
and patients by explaining the purpose and relevance of
the study.
Medical data of the patients with a risk
of falls will be collected, and a detailed cross-checking of the case sheet will
be done with the geriatric assessment later on. Necessary information and the
benefits that they receive will be passed on to the patients regarding the study.
The patients willing to participate will be provided with a consent form for the
same.
After getting the consent from willing
patients, a Geriatric assessment will be
taken with the help of the information gathered from the case sheets and
information provided and elicited from the subjects using a structured
geriatric assessment form.
Subjects
who satisfy the inclusion criteria will be assessed using outcome measures: Berg Balance Scale (BBS), Timed Up and Go
Test (TUG), Functional Reach Test (FRT)
Falls Risk Assessment Tool (FRAT).
After
this the patients are segregated as Group A (Experimental group) and Group B
(Control group) randomly. The scores of
the Berg Balance scale (BBS), Timed Up and Go Test (TUG), Functional Reach Test
(FRT) Falls Risk Assessment Tool (FRAT) of each patient will be entered as pre
data in the data collection sheet a day before the study.
The
patients of Group A (Experimental group)
will be given general information about the methods and the special
interventions ‘Clock Turn Strategy’ (CTS) and Balance Strength Training (BST), and Group B (control group) about Dynamic Balance Training (DBT) and Balance
Strength Training (BST) to be used for
this study.
§
BBS - scoring from 0-56 with higher scores indicating better balance, 14
tasks divided into- Sitting- 4 tasks, Standing- 5 tasks, Transfers -2 tasks,
Balance challenges- 3 tasks. Interpretation: 41-56-low fall risk, 21-40 –
Moderate fall risk, 0-20 High fall risk.
§ TUG - scoring by time (seconds) to complete
task, cut-off Scores: Normative
TUG Scoring for geriatric patients with balance problems and risk of falls. Time
(Seconds): Low risk -Less than or equal to 12 seconds, Moderate risk - 13-19 seconds, High risk -Greater than or equal to 20 seconds.
§FRT -
Normal:> 25.4cm (10 inches), Mild impairment: 15.2-25.5cm (6-10
inches),
Moderate impairment: 10-15.1cm ( 4-6
inches), Severe impairment:< 10 cm
(4inches)
§ Falls
Risk Assessment Tool (FRAT), which can be used to predict who will
fall. The
FRAT has three sections: Part 1 - falls
risk status; Part 2 – risk factor
checklist; and GROUP A (EXPERIMENTAL GROUP)
In the experimental group time of 06
minutes are for patient instruction and for explaining the drawing of the clock
turn pattern on the floor and about the exercises. Balance
Strength Training (BST) and Clock turn Strategy (CTS), which starts with Warm-up
exercise (5minutes), BST exercises (12 minutes), Clock turn strategy training
(12 minutes), Cool-down exercise (5minutes).
Amounting to a total time of 40 minutes.
WARM UP EXERCISES: (5
MINUTES)
•Neck side
flexion (2 repetitions on each side within the possible range) •
• Neck
rotation (2 repetitions each, both sides within the possible range)
•Arm
circles (2 times clockwise
and anti-clockwise for right and left)
•Trunk
twisting (2 repetitions each,
anti-clockwise and clockwise)
•Hip
circles (2 repetitions each,
anti-clockwise and clockwise)
•Marching
and walking for 5 seconds
BALANCE STRENGTH TRAINING (BST) (12 MINUTES)
1 BALANCE EXERCISES:
• Single-Leg Stance (2 sets): Stand on one leg. Eye open and eye closed.
•Foam Pad
(2 sets, 30 seconds). Stand on the Foam pad with eyes open and closed. 2. STRENGTH TRAINING EXERCISES:
Upper extremity:
•Arm Raises (2 sets)
•Shoulder Presses (2sets) Lower Extremity:
•Squats (2 sets)
•Seated Marching (2 sets)
3. CORE:
•Bridge ( 2
sets)
•Seated Leg Press (2 sets)
CLOCK TURN STRATEGY (CTS): (12
MINUTES)
The participants perform a 180-degree turn into two parts, first from 12 to 3 O’clock and then from 3 to 6 O’clock in a clockwise wise, and then back from 6 O’clock to 3 o’clock, then to 12 in an anti-clockwise direction. Anti-clockwise direction from 12 to 9 O’clock and
then from 9 to 6 O’clock, from there back to 9 O’clock and then to 12 O’clock in
clockwise direction.
PROCEDURE OF CLOCK TURN STRATEGY:
The patient will be asked to stand
at a point, a circle will be drawn, and a reading and footprint will be
calibrated on the circle, similar to a clock. The patient will be asked to stand
in the circle where 12 is indicated. The reading will be 12, 3, 6, and 9, similar to a clock. The participants perform a 180-degree turn into two parts, first from 12 to 3 O’clock and then from 3 to 6 O’clock, and then back from 6
O’clock to 3 o’clock, from 3 to 12, which would take around 2 minutes to be completed. A 2-minute
rest will be given to the patient, and he will be allowed to rest and take water
if required. After this, the patient will have to begin again from 12 in an
anti-clockwise direction, 12 to 9 o’clock, and then from 9 to 6, from there back
to 9, and then to 12 O’clock, which will again take 2 minutes for the process to complete.
Patient has to repeat 2 sets in a clockwise wise and 2 sets in the anti-clockwise direction.
As done earlier, a cool-down period of 2 minutes will be given. The patient will
be asked about any difficulties or suggestions. The total period will be for 12
minutes.
COOL-DOWN: (5
MINUTES)
1. Static
stretches for core muscles, Hamstrings, and quadriceps.
2.
Deep Breathing Exercises
DYNAMIC BALANCE TRAINING: (12 MINUTES)
1. Dynamic standing (2 sets, 30 seconds stand with feet
together, shoulder width apart. Shift weight from one
leg to the other.
2. Obstacles course walking (2 sets, 10 steps, navigate through
small
Obstacles, change direction slowly.
3. Balance Reaches (2 sets, stand with feet
shoulder width
Apart, reach for objects in different directions.
COOL-DOWN: (5 MINUTES)
1. Static stretches for core muscles,
Hamstrings, and quadriceps
2. Deep Breathing Exercises
The time for Experimental (group-A )
is 40 minutes, out of which 06 minutes is for patient preparation and instruction, and the remaining 32 minutes for Treatment. Amounting to a total time of 40
minutes.
The time for Control (group – B) is
40 minutes, time of 06 minutes is for patient preparation and instruction, and
the remaining time. 32 minutes is for Treatment, amounting to a total time of 40
minutes.
Treatment is administered thrice a
week on alternate days for 08 weeks and a total of 24 sessions, both
for experimental (group A) and Control (group B).
The scores of
Berg Balance Scale (BBS), Timed Up and Go Test (TUG), Functional Reach
Test (FRT) and Falls Risk Assessment Tool (FRAT) is taken a day before the commencement of treatment and a day after the completion of the treatment and is entered as pre and post data of each individual in the data
collection sheet.
Statistical analysis of this data
will be done subsequently to find the effectiveness of the Clock Turn Strategy on
balance and falls in the geriatric population.
Part 3 – action plan. Total
scoring is 20 : (Low risk: 5-11, Medium risk:12-15,
High risk:16 - 20)
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