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CTRI Number  CTRI/2024/04/066462 [Registered on: 29/04/2024] Trial Registered Prospectively
Last Modified On: 29/04/2024
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   Role of Exercises on the Gait Parameters in Elderly Patients 
Scientific Title of Study   Dual Task Training with Different Priority Instructional Sets on the Gait Parameters in Elderly Patients 
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 Mamta Boora 
Designation  Assistant professor 
Affiliation  Department of physitherapy Guru Jambheshwar university of science and technology 
Address  Room no 105 Department of Physiotherapy Guru Jambheshwar university of science and technology, Hisar

Hisar
HARYANA
125001
India 
Phone  08683810061  
Fax    
Email  mamtaboora50@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mamta Boora 
Designation  Assistant Professor 
Affiliation  Guru Jambheshwar university of science and technology 
Address  Room 09 Department of physiotherapy guru Jambheshwar university of science and technology, Hisar

Hisar
HARYANA
125001
India 
Phone  8683810061  
Fax    
Email  mamtaboora50@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mamta Boora 
Designation  Assistant Professor 
Affiliation  Guru Jambheshwar university of science and technology 
Address  Room 09 Department of physiotherapy guru Jambheshwar university of science and technology, Hisar

Hisar
HARYANA
125001
India 
Phone  8683810061  
Fax    
Email  mamtaboora50@gmail.com  
 
Source of Monetary or Material Support  
Department of Physiotherapy,Guru Jambheshwar university of science and technology, Hisar 125001 haryana india 
 
Primary Sponsor  
Name  Nancy Kamra 
Address  MPT Neurology Department of Physiotherapy Guru Jambheshwar university of science and technology Hisar 125001 haryana india 
Type of Sponsor  Other [] 
 
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 
Mamta Boora  old age home, community centres, neighbourhood and OPD   Guru Jambheshwar University of science and technology, Hisar , Haryana
Hisar
HARYANA 		 8683810061

mamtaboora50@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee Department of physiotherapy Guru jambheshwar university if sciensce and technology  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control   Participants were instructed to continue their regular activities schedule throughout the study  
Intervention  Dual Task training with fixed priority  Patient performed Dual Task training with fixed priority for 3 days in a week for 4 weeks 
Intervention  Dual Task training with Variable priority  Patient performed Dual Task training with variable priority for 3 days in a week for 4 weeks 
 
Inclusion Criteria  
Age From  55.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Subjects within the age group of 55-75 years. Independent ambulators with ability to walk Nine meter without any assistance.
Their MMSE (Mini Mental State Examination) score will be below than 24.
Number of falls should be atleast 2 in the previous years.
 
 
ExclusionCriteria 
Details  History of any other neurological, musculoskeletal and cardiovascular condition that affected balance.
Any history of dizziness.
Any uncorrected severe hearing and visual impairment which will affect the balance and gait in elderly.
Receipt of physical therapy or enrollment in any other formal exercise program at the same time 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Cognition
Balance
Stride length on Comfortable or Maximal Walking Speed
Step length on Comfortable or Maximal Walking Speed 		 Cognition by MMSE Scale
Balance by BBS
Stride length was measured before the start of intervention (0 week) & after the completion of intervention (4 weeks)
Step length (0 week) & after the completion of intervention (4 weeks) 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
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)   28/05/2024 
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="3"
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 ability to complete two activities at once is known as dual-tasking. Poor dual-task performance during gait increases the risk of falls, lowers functional capacities, and lowers quality of life and dual tasks are necessary in daily living, such as conversing while walking or carrying a suitcase while, walking performance is impacted by both cognitive and motor dual functions, especially in the older population, which results in a drop in speed and an increase in stride duration  stride time, variability and Gait impairment raises the possibility of falling. Numerous studies have been done on single versus dual task balance training to improve gait parameters, balance and cognition in elderly population. However, in our knowledge, none of the studies examined the efficacy of dual-task training with either fixed or variable priority instructional sets on gait parameters such as stride and step length, balance and cognition among elderly with balance impairment. Therefore, this study is required to assess the gait parameters and the effect of dual task training on balance and cognition. 
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