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CTRI Number  CTRI/2026/01/102518 [Registered on: 30/01/2026] Trial Registered Prospectively
Last Modified On: 30/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Cawthorne–Cooksey Exercises Combined with Physiotherapy on Balance and Mobility in Children with Down Syndrome. 
Scientific Title of Study   Added effect of Cawthorne Cooksey Exercises along with Conventional Physiotherapy on Balance and Mobility in children with Downs Syndrome. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Janhavi Jadhav PT 
Designation  PG Student 
Affiliation  MAEERS Physiotherapy College Talegaon Dabhade 
Address  A230 Neurophysiotherapy, 2nd floor , OPD Building, BSTR Hospital, near MIMER Medical College Campus, Talegaon Station Rd, Talegaon Dabhade, Maharashtra 410507

Pune
MAHARASHTRA
410507
India 
Phone  9082659167  
Fax    
Email  janhavisatishjadhav@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Tanpreet Mehta PT 
Designation  Associate Professor 
Affiliation  MAEERS Physiotherapy College Talegaon Dabhade 
Address  A230 Neurophysiotherapy, 2nd floor , OPD Building, near MIMER Medical College Campus, Talegaon Station Rd, Talegaon Dabhade, Maharashtra 410507

Pune
MAHARASHTRA
410507
India 
Phone  9960900260  
Fax    
Email  tanpreetkaurb8@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrJanhavi Jadhav PT 
Designation  PG Student 
Affiliation  MAEERS Physiotherapy College Talegaon Dabhade 
Address  A230,2nd floor , OPD Building, near MIMER Medical College Campus, Talegaon Station Rd, Talegaon Dabhade, Maharashtra

Pune
MAHARASHTRA
410507
India 
Phone  9082659167  
Fax    
Email  janhavisatishjadhav@gmail.com  
 
Source of Monetary or Material Support  
Neurophysiotherapy OPD,MAEERS Physiotherapy college, 2nd floor , OPD Building, near MIMER Medical College Campus, Talegaon Station Rd, Talegaon Dabhade, Maharashtra 410507  
 
Primary Sponsor  
Name  Dr. Janhavi Satish Jadhav PT 
Address  15 Prajakta CHS LTD, Bamanwada, Sahar Road, Andheri East, Mumbai-400099 
Type of Sponsor  Other [Self Financed] 
 
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 
Dr Janhavi Jadhav PT  MAEERS Physiotherapy College , Bhausaheb Sardesai Talegaon Rural Hospital   A230 Neurophysiotherapy OPD,2nd floor,MAEERS Physiotherapy College, OPD Building,BSTR Hospital, near MIMER Medical College Campus, Talegaon Station Rd, Talegaon Dabhade, Maharashtra 410507
Pune
MAHARASHTRA 		 9082659168

janhavisatishjadhav@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MAEERS Physiotherapy College Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q909||Down syndrome, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cawthorne Cooksey Exercises in addition to Conventional Physiotherapy  CAWTHORNE COOKSEY EXERCISES PROTOCOL- Applied to Participants in Group B (3 days/ 4 weeks) A) Eye and head movement, sitting down – first slowly, then faster: 1) Look up and down 2) Look to the right and to the left 3) Bring your fingers closer and farther, looking at it 4) Move your head (slowly and then faster) to the right and to the left, with open eyes 5) Move your head (slowly and then faster) up and down, with open eyes 6) Repeat 4 and 5 with closed eyes. B) Head and body movement, sitting down: 1) Place an object on the floor. Take it and bring it above your head and place it on the floor again (look at the object the whole time) 2) Shrugging your shoulders and make circular movements 3) Bend forward and take an object through the back and front of your knees. C) Standing up exercises: Repeat A and B2 1) Sit down and stand up, sit down and stand up again 2) Sit down and stand up; Sit down and stand up again with closed eyes 3) Stand up, but turn to the right while standing 4) Stand up, but turn to the left while standing 5) Throw a small ball from one hand to the other (above the eye level) 6) Throw a small ball from one hand to the other under your knees and alternatively. 
Comparator Agent  Conventional Physiotherapy  Treatment Protocol CONVENTIONAL PHYSIOTHERAPY- Both Group A and Group B will receive conventional physiotherapy protocol ( 3 days per week/ 4 weeks) ( Note-Protocol will be tailor made as per the individual assessment parameters of the participants) Core Training (10 repetitions, 3 days/week) 1] Abdominal Curls 2] Bridging 3] Prone on elbow 4] Quadruped with Reach outs Strengthening Exercises (10 repetitions, 3 days/week) 1] Lower Limb Strengthening (Hip, Knee ,Ankle) 2] Seated Marches 3] Standing Marches 4] Lunges 5] Mini-Squats Strength training will be started at 50% of 1RM. Resistance exercises will be done using sandbags. The resistance will be increased by half a kilogram when the child will be able to complete the sets with ease and without undue stress. Balance Exercises (10 repetitions, 3 days/week) 1] One leg stance with eye open 2] Tandem stance 3] Walking on line 4] Standing on balance board 5] Figure of 8 walking 6] Walking across obstacles (blocks, books, wedges, and rolls of different sizes) 7] Walking in three directions: backwards, forwards, and sideway. Exercises will be increased by five repetitions when the child will be able to do it with ease.  
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Children’s with Downs syndrome between age 6-18 years.
Able to walk independently.
Able to follow simple verbal instructions.
Dynamic Visual Acuity Test –positive
Interpretation - A dynamic visual acuity of 3 or more lines above static visual acuity assessed using HOVT Chart indicates a vestibular defect  
 
ExclusionCriteria 
Details  Children’s with Downs syndrome
Known case of atlantoaxial instability.
Known case of uncontrolled cardiopulmonary problems Any known orthopedic procedure in Past 6 months.
Uncontrolled epilepsy within 6 months. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Balance assessed using Pediatric Balance Scale (PBS).
2. Mobility assessed using Time Up and Go Test.
3.Vestibular Dysfunction assessed using Dynamic Visual
Acuity Test. 		 T0-Baseline assessment done Pre-Intervention.
T1-Assessment done Post-Intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   11/02/2026 
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)   Not Yet Recruiting 
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  
Children with Down’s syndrome commonly present with hypotonia, joint hypermobility, delayed motor development, and impaired balance and mobility, largely due to associated vestibular dysfunction. Conventional physiotherapy focuses on improving strength, posture, and functional mobility; however, targeted vestibular rehabilitation is less frequently incorporated despite known vestibular abnormalities in this population. Cawthorne-Cooksey Exercises (CCE) are structured vestibular rehabilitation exercises designed to enhance gaze stability, postural control, and balance through coordinated eye, head, and body movements.
This experimental study aims to evaluate the added effect of Cawthorne-Cooksey Exercises combined with conventional physiotherapy compared to conventional physiotherapy alone on balance, mobility, and vestibular function in children with Down’s syndrome aged 6–18 years. A total of 36 participants will be randomly allocated into two groups: Group A receiving conventional physiotherapy and Group B receiving CCE along with conventional physiotherapy for four weeks. Outcome measures include the Pediatric Balance Scale, Timed Up and Go Test, and Dynamic Visual Acuity Test, assessed pre- and post-intervention. The findings of this study may provide evidence for integrating vestibular-focused exercises into routine physiotherapy rehabilitation to improve functional outcomes and quality of life in children with Down’s syndrome.
 
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