CTRI Trial Data

PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Sat, 25 Sep 2021 23:42:29 GMT) CTRI Number CTRI/2016/10/007337 [Registered on: 05/10/2016] - Trial Registered Retrospectively Last Modified On 05/10/2016 Post Graduate Thesis No Type of Trial Interventional Type of Study Physiotherapy (Not Including YOGA) Study Design Randomized, Parallel Group, Active Controlled Trial Public Title of Study Effectiveness of Physiotherapy training to improve control of sitting on floor. Scientific Title of Improving deep knee flexion activities (squatting and sitting on the floor)in persons with stroke using Study functional exercise Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name V Prakash Trial Coordinator (multi-center study) Designation Assistant Professor Affiliation Ashok and Rita patel Institute of Physiotherapy,Charotar University of Science and Technology Address Charotar University of Science And Technology Changa Anand GUJARAT 388421 India Phone 7874671938 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name V Prakash Query) Designation Assistant Professor Affiliation Ashok and Rita patel Institute of Physiotherapy,Charotar University of Science and Technology Address Charotar University of Science And Technology Changa Anand GUJARAT 388421 India Phone 7874671938 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name V Prakash Designation Assistant Professor Affiliation Ashok and Rita patel Institute of Physiotherapy,Charotar University of Science and Technology Address Charotar University of Science And Technology Changa Anand GUJARAT 388421 India Phone 7874671938 page 1 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Ashok and Rita Patel Institute of Physiotherapy,Charotar University of Science and Technology, CHARUSAT Campus, Changa, Ta.Petlad, Dist.Anand, Gujarat-388421 Primary Sponsor Primary Sponsor Details Name Principal Investigator Address Prakash Vaidhiyalingam Assistant Professor Ashok and Rita Patel Institute of Physiotherapy Charotar University of Science and Technology Changa, Anand Gujarat Type of Sponsor Other [Primary Investigator Institution] Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr V Prakash CHARUSAT Hostpital Room No 113, 7874671938 Nero-physiotherapy Unit,Department of prakashvaidhiyalingam Physiotherapy @gmail.com Anand GUJARAT Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institutional Review Approved 30/01/2015 No Board Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Stroke Intervention / Type Name Details Comparator Agent Intervention Task oriented exercise Random practice of sit-to stand, half squat, semi squat and deep squat exercises and home program consisting of same exercises Comparator Agent Impairment oriented exercise a.Lunges with the affected limb forward. b.sit to stand from a standard stool (42-45 cm) raising on the toes c.Step over a small block (measuring 21-16 cm approximately) using the affected limb alternating with the unaffected limb. d.Side stepping e.Performing turning on the spot. Inclusion Criteria Inclusion Criteria Age From 45.00 Year(s) Age To 70.00 Year(s) Gender Both page 2 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Details 1.1 to 12 months duration. 2.any artery affection including Middle cerebral artery, Anterior cerebral artery or Posterior cerebral artery and Ischemic or Haemorhagic Type. 3.Both male and female between the age group of 45 to 70. 4.They should have consented to participate in the study and having deep knee flexion activity improvement as a goal 5.Able to perform sit to stand 3 times without support from a standard chair. 6.They should have a score of greater than 23 on Mini Mental Scale examination. Exclusion Criteria Exclusion Criteria Details 1.People who have musculoskeletal clinical conditions that restrict them from successfully completing deep knee flexion activities, such as pain with a VAS Score greater than 7, contractures and recent fracture. 2. Unstable cardiac conditions that would contraindicate participation in an exercise program and communication difficulties such as Wernicke’s or Broca’s aphasia that makes it difficult for them to understand the exercise instructions would be excluded from the study. 3. Gross perceptual problem (e.g hemineglect, pusher syndrome etc) will be excluded by performing the following test a. drawing test b. star cancellation test c. line bisection test Method of Generating Computer generated randomization Random Sequence Method of Centralized Concealment Blinding/Masking Outcome Assessor Blinded Primary Outcome Outcome Timepoints Attainment of squatting and sitting on the floor 1 month, 3 months and 6 months using goal attainment scale Secondary Outcome Outcome Timepoints Lower limb motor recovery using Fugl Meyer 1 month, 3 months and 6 months Scale Lower limb strength using Motricity Index 1 month, 3 months and 6 months Fear of fall using short fall efficacy scale 1 month, 3 months and 6 months Ability to Participate in Social Roles and 1 month, 3 months and 6 months Activities using Neuro QOL-Short form Target Sample Size Total Sample Size=50 Sample Size from India=50 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 11/09/2015 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=1 Trial Months=6 Days=15 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Open to Recruitment page 3 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Trial (India) Publication Details Brief Summary page 4 / 4 Powered by TCPDF (www.tcpdf.org).

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