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CTRI Number  CTRI/2023/05/053338 [Registered on: 31/05/2023] Trial Registered Prospectively
Last Modified On: 25/05/2023
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 DOUBLE TASK EXERCISES VS SIMILARITY EXERCISES ON WALKING SPEED AND BALANCE IN OLDER PEOPLE.  
Scientific Title of Study   “EFFECT OF DUAL TASK TRAINING VERSUS ANALOGY TRAINING ON GAIT SPEED AND BALANCE IN OLDER ADULTS.”  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Chetana tetgure 
Designation  Post graduate  
Affiliation  Dr.D.Y.Patil college of physiotherpy,Pimpri  
Address  Dr.D.Y.Patil college of physiotherpy Pimpri. 190, Dr DY Patil College Rd, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
Dr.D.Y.Patil college of physiotherpy Pimpri. 190, Dr DY Patil College Rd, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA
411018
India 
Phone  7304681063  
Fax    
Email  chetanatetgure20@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Reema Joshi 
Designation  Associate professor  
Affiliation  Dr.D.Y.Patil college of physiotherpy,Pimpri  
Address  Dr.D.Y.Patil college of physiotherpy Pimpri. 190, Dr DY Patil College Rd, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
Dr.D.Y.Patil college of physiotherpy Pimpri. 190, Dr DY Patil College Rd, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA
411018
India 
Phone  9890437630  
Fax    
Email  reema.joshi@dpu.edu.in  
 
Details of Contact Person
Public Query
 
Name  Chetana tetgure 
Designation  Post graduate  
Affiliation  Dr.D.Y.Patil college of physiotherpy,Pimpri  
Address  Dr.D.Y.Patil college of physiotherpy Pimpri. 190, Dr DY Patil College Rd, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
Dr.D.Y.Patil college of physiotherpy Pimpri. 190, Dr DY Patil College Rd, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA
402104
India 
Phone  7304681063  
Fax    
Email  chetanatetgure20@gmail.com  
 
Source of Monetary or Material Support  
Dr. D.Y.Patil college of physiotherpy, Pimpri Pune. 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
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 
CHETANA TETGURE   Dr.D.Y.Patil college of Physiotherapy, pimpri   Ground floor 1 cabin , Dr.D.Y.Patil college of Physiotherapy ,Sant tukaram nagar , Pimpri,Pune .
Pune
MAHARASHTRA 
7304681063

chetanatetgure20@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee of DR.D.Y.patil college of Physiotherapy,Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy volunteers  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Analogy training   3 session/ week 1st week-walk as if you follow footprints. 2nd week- Try to cross a small bridge 3rd week-walk as if you are Crossing the signal on road 4th week-walk imagining you are kicking a football in front of you.  
Comparator Agent  Control group   - Walking advice and conventional therapy  
Intervention  Dual task   3 session/ week 1st week- walk with counting backwards. 2nd week- Walk with counting backwards ,Obstacles walking,Speed alterations 3rd week- Walk with counting backwards,Zic sac patterns,Speed alteration 4th week-Walk with counting backwards,Figure of 8 patterns Speed alteration  
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  74.00 Year(s)
Gender  Both 
Details  1)Both male and female .
2) subject youngest old adults .
3) Mini Mental State Examination score 24 or higher out of 30
4) Tinetti’s Performance Oriented Mobility Assessment Scale (POMA) score higher than 19 out of 28.
5) Time up and go test score more than 20 secs .
 
 
ExclusionCriteria 
Details  1)Neurological impairments
2)Recent fracture
3)Visual impairments.( which cannot be corrected by glass)
4) vestibular impairment
5) Use of assistive device (cane, walker)
6) cognitive impairments
7) Presence of artificial prosthesis
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. 10 meter walk test
2. Time up and go test
3. Mini Mental state examination scale
4. Tinetti’s Performance Oriented Mobility Assessment scale (POMA)
5.Modified fall efficacy scale
6. Activities-Specific Balance confidence scale
 
At the beginning and at the end of the study ( 4 weeks)
 
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable   Not applicable  
 
Target Sample Size   Total Sample Size="69"
Sample Size from India="69" 
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   Phase 1 
Date of First Enrollment (India)   10/08/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/08/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Successful aging suffer less from declining abilities and enjoy a relatively higher level of cognitive wellness through the reorganization of brain networks. While, cognitive aging is typically associated with reductions of attention and memory capacities. Aging also can affect attention capacity ,executive control, working memory, processing speed and episodic memory which results poorer working memory, and poor processing speed .which also can affect the walking pattern in older adults. Walking is a complex process involving the interaction of neuromuscular, sensory, and cognitive functions, all of which deteriorate with aging. Both cognitive and motor task impact the walking performance, including decreased speed, increased stride time and stride time variability, especially in the older population. Which can lead to falls, reduced confidence, reduced functional mobility and quality of life in older adults. Therefore, there is a need to develop interventions to improve walking performance in older adults. Cognitive strategies, such as attentional strategies (self-generated with an internal focus), the use of external cues (auditory, visual or tactile), or self-instruction strategies can be beneficial in improving gait. Using motor learning strategies with cognitive function can strengthen working memory, increase processing speed and to improve multitasking performance. Implicit motor learning strategies describe as learning that progress with non or minimal increase in verbal knowledge of movement performance without awareness. Practical approach to use implicit motor learning is using analogies. Prefrontal cortex (PFC) plays a crucial role in cognitive function and was evident to be involved in dual tasking. Increased activation in PFC was observed during dual task walking healthy adults, and older adults tended to activate more compared to younger participants. Other Motor brain areas such as premotor cortex (PMC) and supplemental motor area (SMA) were also found to activate during dual task walking, which were responsible for stabilizing gait and adapting walking speed. Hence there is need to explore the potential impact of dual-task, analogy training on rehabilitation outcomes it could provide practical insights for the development of future therapeutic interventions for fall prevention programs. 





 
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