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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. 
Scientific Title of Study   Effectiveness of Clock Turn Strategy On Balance And Fall In Geriatric Population  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
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  
 
Source of Monetary or Material Support  
Great Jubilee Memorial, Alphonsa Abhaya Bhavan, Alphonsapuram, Arpookara East PO, Kottayam – 686008, Kerala  
 
Primary Sponsor  
Name  Shyni M 
Address  School Of Medical Education Centre For Professional And Advanced Studies Kottayam 686008 Kerala 
Type of Sponsor  Other [SELF ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z878||Personal history of other specified conditions,  
 
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  
 
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.



 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
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).


 
 
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" 
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  

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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