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CTRI Number  CTRI/2026/02/103336 [Registered on: 09/02/2026] Trial Registered Prospectively
Last Modified On: 06/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study on sway training using Lord sway meter to reduce body sway and improve balance in Down syndrome children 
Scientific Title of Study   Feasibility and effectiveness of Lord sway meter in improving postural sway and balance in children with Down syndrome over conventional physiotherapy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR UPPULA SHIVANI 
Designation  Post Graduate student 
Affiliation  Durgabai Deshmukh College Of Physiotherapy 
Address  Physiotherapy OPD Ground floor Exercise therapy room DDH campus Durgabai Deshmukh Hospital and Research Centre Vidya nagar Adikmet Osmania University road Hyderabad

Hyderabad
TELANGANA
500044
India 
Phone  9100843678  
Fax    
Email  shivaniuppula49@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR A DURGA REDDY 
Designation  Professor 
Affiliation  Durgabai Deshmukh College Of Physiotherapy 
Address  Physiotherapy OPD Ground floor Exercise therapy room DDH campus Durgabai Deshmukh Hospital and Research Centre Vidya nagar Adikmet Osmania University road Hyderabad

Hyderabad
TELANGANA
500044
India 
Phone  9492925784  
Fax    
Email  abbadidurga@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR A DURGA REDDY 
Designation  Professor 
Affiliation  Durgabai Deshmukh College Of Physiotherapy 
Address  Physiotherapy OPD Ground floor Exercise therapy room DDH campus Durgabai Deshmukh Hospital and Research Centre Vidya nagar Adikmet Osmania University road Hyderabad

Hyderabad
TELANGANA
500044
India 
Phone  9492925784  
Fax    
Email  abbadidurga@gmail.com  
 
Source of Monetary or Material Support  
Physiotherapy OPD Ground floor Exercise therapy room DDH campus Durgabai Deshmukh Hospital and Research Centre Vidya nagar Adikmet Osmania University road Hyderabad Telangana 500044 India 
 
Primary Sponsor  
Name  DR UPPULA SHIVANI 
Address  Physiotherapy OPD Ground floor Exercise therapy room DDH campus Durgabai Deshmukh Hospital and Research Centre Vidya nagar Adikmet Osmania University road Hyderabad Telangana 500044 India 
Type of Sponsor  Research institution and hospital 
 
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 UPPULA SHIVANI  Durgabai Deshmukh Hospital and Research Centre  Physiotherapy OPD Ground floor Exercise therapy room DDH campus Vidya nagar Adikmet Osmania University road
Hyderabad
TELANGANA 		 9100843678

shivaniuppula49@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Durgabai Deshmukh Hospital And Research Centre  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 
Comparator Agent  Conventional Physiotherapy  Control Group Will Receive Core Strengthening Postural Control And Balance Exercises For 40 Minutes Per Session For 5 Days In A Week For 6 Weeks. The Core Strengthening Exercises Given To Be Included Are Pelvic Tilts Pelvic Bridging In Week 1 Abdominal Curls Prone Lying With Head And Shoulder Lift In Week 2 Quadruped Exercises Like Bird Dog Rocking Movements In Week 3 Sitting On Therapy Ball Involves Perturbations Reaching Activities Ball Roll Outs In Week 4. During 5 And 6 Week The Repetitions And Sets Of Exercise Are Gradually Progressed. Postural Control And Balance Exercises Include Standing On Firm Surface With Wide Base To Narrow Base Gradually In Week 1 Weight Shiftings From Side To Side Forward To Backward In Week 2 Tandem Standing Single Leg Standing In Week 3 Ball Activities In Standing Involves Throwing Catching Kicking In Week 4. During 5 And 6 Week The Repetitions And Sets Of Exercise Are Gradually Progressed. Each Exercise Will Be Initially Performed For 10 Repetitions With One Set From Week 1 To Week 4. In Week 5 The Exercises Are Performed For 15 Repetitions With 2 Sets And In Week 6 Exercises Performed For 20 Repetitions With 2 Sets.  
Intervention  Lord Sway Meter Training  Experimental Group Will Receive Lord Sway Meter Training For 40-60 Minutes Per Session For 5 Days In A Week For 6 Weeks. Sway Training Will Be Given To The Children With In Their Limit Of Stability Using Verbal Feedback Initially In Week 1 The Participant Is Made To Stand On A Firm Surface With Eyes Open Followed By Eyes Closed In Week 2. Progression Is Made From Firm To Foam Surface With Eyes Open In Week 3 Followed By Eyes Closed In Week 4. During Week 5 And 6 The Limit Of Stability Is Reduced While Continuing All Previously Performed Exercises Training Is Gradually Progressed In Regards Of Time And Type Of Exercise 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children who are interested and cooperative will be included
Children with IQ 50-69 capable of understanding visual and verbal instructions
Montreal cognitive assessment score greater than 24
Children who can stand and walk independently with balance problems
Pediatric berg balance score is greater than 35 smaller than 40
Balance evaluation system test score is 73 to 80 out of 108
 
 
ExclusionCriteria 
Details  Children who were on medical treatment that restricted their participation in the study
Children with associated musculoskeletal or cardiac problems were excluded
Associated visual and auditory problems 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Lord sway meter  Assessed at Base line and after 6 weeks of treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Pediatric Balance Scale
Balance Evaluation System Test 		 Assessed at Base line and after 6 weeks of treatment 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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)   20/02/2026 
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 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  
The study is focusing on to examine the effectiveness of Lord sway meter in Down Syndrome children who are presenting with increased postural sway and balance deficit due to hypotonia ligament joint laxity muscle imbalance proprioceptive deficits etc. It is an Experimental Randomized control trial with sample size of 52 participants randomized in to two groups 26 participants in each group using lottery method. Interventional group will receive sway training using lord sway meter along with conventional physiotherapy,  Where Control group will receive conventional physiotherapy includes core strengthening postural control and balance exercises. The treatment will be given for 40 minutes for both groups with an additional 5-20 minutes for experimental group for 5 days in a week for 6 weeks. Outcomes included are Lord Sway Meter, Pediatric Balance Scale, Balance Evaluation System Test which are measured at baseline and after 6 weeks of treatment. Collected data at baseline and after 6 weeks of treatment will be analyzed with in and between groups statistically. Through the results of this study we can determine whether Lord sway meter is feasible and effective for training postural sway and balance deficits in down syndrome children.
 
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