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Clinical Trial Details (PDF Generation Date :- Thu, 30 Sep 2021 19:19:39 GMT)
CTRI Number CTRI/2014/08/004932 [Registered on: 27/08/2014] - Trial Registered Prospectively Last Modified On 18/09/2014 Post Graduate Thesis No Type of Trial Observational Type of Study Cross Sectional Study Study Design Single Arm Trial Public Title of Study Real change in standing balance test in adolescents with Down syndrome Scientific Title of Minimal Detectable Change of the standing balance test in adolescents with Down syndrome: how Study much change is true change? Secondary IDs if Any Secondary ID Identifier U1111-1160-8065 UTN Details of Principal Details of Principal Investigator Investigator or overall Name Vencita Priyanka Aranha Trial Coordinator (multi-center study) Designation PG Student Affiliation Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation Address Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation, Mullana- 133 207, Ambala District, Haryana, India Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation, Mullana- 133 207, Ambala District, Haryana, India Ambala HARYANA 133207 India Phone 8607274555 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name ASIR JOHN SAMUEL Query) Designation Assistant Professor Affiliation Maharishi Markandeshwar University Address Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation, Mullana- 133 207, Ambala District, Haryana, India Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation, Mullana- 133 207, Ambala District, Haryana, India Ambala HARYANA 133207 India Phone 8059930222 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Vencita Priyanka Aranha Designation PG Student Affiliation Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation Address Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation, Mullana- 133 207, Ambala District, Haryana, India
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Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation, Mullana- 133 207, Ambala District, Haryana, India
HARYANA 133207 India Phone 8607274555 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation, Mullana- 133 207, Ambala District, Haryana, India Primary Sponsor Primary Sponsor Details Name Asir John Samuel Address Assistant Professor, Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation, Mullana- 133 207, Ambala District, Haryana, India Type of Sponsor Other [Individual] Details of Secondary Name Address Sponsor NA NA Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Vencita Priyanka Neurorehabilitation Lab PG student, Maharishi 8607274555 Aranha Markandeshwar Institute of [email protected] physiotherapy and Rehabilitation, Mullana- 133 207, Ambala District, Haryana, India Ambala HARYANA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? MMIPR, Institutional Approved 02/08/2014 No Research and Ethics committee Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Children with Downs syndrome Intervention / Type Name Details Comparator Agent Intervention Not Applicable Not Applicable Comparator Agent Not Applicable Not Applicable Inclusion Criteria Inclusion Criteria Age From 11.00 Year(s) Age To 17.00 Year(s) Gender Both Details 1.Adolescents with downs syndrome
2.Who were able to
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understand and obey simple commands
3.Able to stand without support Exclusion Criteria Exclusion Criteria Details 1. Non cooperative 2. Mentally retarded with low IQ Method of Generating Not Applicable Random Sequence Method of Not Applicable Concealment Blinding/Masking Participant and Outcome Assessor Blinded Primary Outcome Outcome Timepoints Standing Balance measured in seconds (s). That 3 times is, the duration of time the adolescents stood without loosing balance Secondary Outcome Outcome Timepoints Not applicable Not applicable Target Sample Size Total Sample Size=9 Sample Size from India=9 Final Enrollment numbers achieved (Total)= Final Enrollment numbers achieved (India)= Phase of Trial N/A Date of First 15/09/2014 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=2 Days=1 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Completed Trial (India) Publication Details Not applicable Brief Summary A sample of nine adolescents with Down syndrome, aged between 11 and 17 years will be recruited randomly from the recognized special school. Adolescents who were able to understand and obey simple commands will be selected and noted their anthropometric measurements. Standing balance will be assessed using timed unipedal stance on a hard floor for static and on foam with uniform density for dynamic balance. They will be asked to stand on 1 leg with the opposite knee held at 90? of flexion and with the upper limbs relaxed. One rater will be assessing the standing balance twice in four conditions, Eyes Open Static (EOS), Eyes Closed Static (ECS), Eyes Open Dynamic (EOD) and Eyes Closed Dynamic (ECD) at an interval of two days to estimate test retest reliability, expressed in terms of Pearson’s correlation co-efficient (r). Then standard
error of measure (SEM) and minimal detectable change (MDC95) will be calculated.
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