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CTRI Number  CTRI/2021/04/032719 [Registered on: 09/04/2021] Trial Registered Prospectively
Last Modified On: 08/04/2021
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   To check and compare Effects of obstacle walking under dual task on confidence level and mobility in elderly population 
Scientific Title of Study   Effects of Dual task obstacle walking v/s Dual task walking on functional mobility and balance confidence in Community dwelling elderly population. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Chetna Jain 
Designation  MPT 1 Masters in Neuro Physiotherapy 
Affiliation  Sancheti Institute College of Physiotherapy 
Address  1st floor, Department of neuro physiotherapy, Sancheti Institute College of Physiotherapy, 12 Thube Park, Shivajinagar, Pune

Pune
MAHARASHTRA
411005
India 
Phone  8087963811  
Fax    
Email  jain.chetna33@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vivek Kulkarni 
Designation  Principal, Sancheti Institute College of Physiotherapy 
Affiliation  Sancheti Institute College of Physiotherapy 
Address  1st floor, Department of neuro physiotherapy, Sancheti Institute College of Physiotherapy, 12 Thube Park, Shivajinagar, Pune

Pune
MAHARASHTRA
411005
India 
Phone  9890611747  
Fax    
Email  vnkulkarni19@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Vivek Kulkarni 
Designation  Principal, Sancheti Institute College of Physiotherapy 
Affiliation  Sancheti Institute College of Physiotherapy 
Address  1st floor, Department of neuro physiotherapy, Sancheti Institute College of Physiotherapy, 12 Thube Park, Shivajinagar, Pune

Pune
MAHARASHTRA
411005
India 
Phone  9890611747  
Fax    
Email  vnkulkarni19@yahoo.co.in  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Sancheti Institute College of Physiotherapy 
Address  Sancheti Institute College of Physiotherap 
Type of Sponsor  Other [College of Physiotherapy 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 
Chetna Jain  Sancheti hospital Institute for Orthopaedics and Rehabilitation  Neuro settings,Department of Neuro Physiotherapy, Pune Pune MAHARASHTRA
Pune
MAHARASHTRA 		 08087963811

jain.chetna33@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee Sancheti Institute Orthopaedics and rehabilitation  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Elderly population 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dual task obstacle walking  Crossing Four obstacles on 10 meter pathway along with cognitive task for 15-20 minutes, 3 times a week for 3 weeks. 
Comparator Agent  Dual task walking  walking on 10 meter pathway and simultaneously performing cognitive task for 15-20 minutes. 3 times a week for 3 weeks 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1) Able to walk 10 meters with or without assistive devices
2) Score greater than or equal to 24 on the Mini-Mental State Examination (MMSE)  
 
ExclusionCriteria 
Details  1)Any Neurological disorders affecting balance and Gait
2) Any Musculoskeletal deformities of lower limbs affecting balance and Gait
3) Uncorrected hearing and visual impairments.
4) On anti-depressants 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Functional mobility will be assessed Timed Up and Go test  Pre assessment (0 week)
Post assessment (3 week) 
 
Secondary Outcome  
Outcome  TimePoints 
Balance confidence by using Activity Specific balance confidence scale  Pre assessment (0 week)
Post assessment (3 week) 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   15/04/2021 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This is an experimental study to see the effects of Dual Task obstacle walking v/s Dual task walking on functional mobility and balance confidence in Community dwelling elderly population. One group will receive Dual task obstacle walking and other group will receive Dual task walking. In Dual task Obstacle walking (Experimental)- group four obstacles will be placed on 10 m pathway and participants has to walk at comfortable speed and to navigate over the obstacles while simultaneously performing a cognitive task like subtracting 3 randomly from 60-100.Task will be performed for 15-20 minutes along with general mobility exercises 3 times a week for 3 weeks . In Dual task walking(Control) group participants has to walk at comfortable speed while simultaneously performing a cognitive task like subtracting 3 randomly from 60-100.Task will be performed for 15-20 minutes along with general mobility exercises 3 times a week for 3weeks. Functional mobility will be assessed by Timed Up and Go Test and Balance confidence will be assessed by Activity specific Balance Confidence Scale pre and post treatment. Data will be analyzed using statistical test within and between the groups. 
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