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CTRI Number  CTRI/2023/09/057419 [Registered on: 11/09/2023] Trial Registered Prospectively
Last Modified On: 18/09/2024
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   Effect Of Motor Dual Task Training On Balance And Quality Of Life In Elderly Fallers - A Randomized Control Trial. 
Scientific Title of Study   Effect Of Motor Dual Task Training As Compared To Conventional Balance Training On Balance And Quality Of Life In Elderly Fallers - A Randomized Control Trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aayushi Atal 
Designation  Post Graduate 
Affiliation  Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy 
Address  Community Physiotherapy Department Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy 11/12 Thube Park Shivajinagar Pune 411005

Pune
MAHARASHTRA
411005
India 
Phone  7219222131  
Fax    
Email  aayushiatal2018@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Suroshree Mitra 
Designation  Professor and HOD 
Affiliation  Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy 
Address  Community Physiotherapy Department Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy 11/12 Thube Park Shivajinagar Pune 411005

Pune
MAHARASHTRA
411005
India 
Phone  8087715596  
Fax    
Email  drsurmitra@gmail.com  
 
Details of Contact Person
Public Query  
Name  Aayushi Atal 
Designation  Postgraduate 
Affiliation  Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy 
Address  Community Physiotherapy Department Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy 11/12 Thube Park Shivajinagar Pune 411005

Pune
MAHARASHTRA
411005
India 
Phone  7219222131  
Fax    
Email  aayushiatal2018@gmail.com  
 
Source of Monetary or Material Support  
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy 
 
Primary Sponsor  
Name  Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy  
Address  Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy 11/12 Thube Park Shivajinagar Pune 411005 
Type of Sponsor  Private medical college 
 
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 
Dr Aayushi Atal  Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy  Community Physiotherapy Department Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy 11/12 Thube park Shivajinagar Pune
Pune
MAHARASHTRA 		 7219222131

aayushiatal2018@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sancheti Institute for Orthopaedics and Rehabilitation Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Elderly Fallers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Balance Training   1) Unilateral stance 2) Walking with head turns 3) Slalom walking 4) Transferring from one chair to another 5) Lateral Foot Scooting 6) Ascending and descending stairs. Unilateral Stance - 15 sec hold followed by 5 sec rest; 10 repetitions. 2 minutes walking for each followed by a rest period of 30 seconds; 2 repetitions. Sessions will be taken for thrice a week for 4 weeks. 
Intervention  Motor Dual Task Training   1) Unilateral Stance. 2) Walking forward at a fast speed and returning walking backwards with head turns. 3) Slalom Walking. 4) Transferring from one chair to another. 5) Tandem Walking. 6) Lateral Foot Scooting 7) Ascending and Descending Stairs. All these exercises will be done simultaneously while carrying a glass of water. Unilateral Stance - 15 sec hold followed by 5 sec rest; 10 repetitions. 2 minutes walking for each followed by a rest period of 30 seconds; 2 repetitions. Sessions will be taken for thrice a week for 4 weeks. 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1) score ≥ 24 on the Mini-Mental State Exam (MMSE),
2) Functionally independent and willing to participate.
 
 
ExclusionCriteria 
Details  1) Patients with any surgical history for the spine or lower limb in the past 6 months.
2) history of cerebrovascular accidents.
3) use of medication(s) such as sedatives and hypnotics, antidepressants and benzodiazepines.
4) have some chronic health condition for which physical exercise is contraindicated.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Community Balance & Mobility Scale  At baseline (0 weeks) & after intervention (after 4 weeks) 
 
Secondary Outcome  
Outcome  TimePoints 
WHOQOL BREF  At baseline (0 weeks) & after intervention (after 4 weeks) 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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)   15/09/2023 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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   One of the most common occurrences in older adults is fall that leads to serious injuries. This leads to public health issues in elderly by hampering their functional activity. Daily activities include dynamic functional tasks that require combined motor tasks. In people with altered balance combined motor dual activity will be hampered. Many studies show the positive effects of dual task training on balance but they have not reviewed more of the motor component. Motor component of dual task training seems to be not much explored in the elderly fallers. Outcome Measures to be used are Community Balance and Mobility Scale for Balance and WHOQOL-BREF for Quality of Life at baseline and after 4 weeks. Randomized Control Trial will be done on 84 participants where they will be given same set of exercises for same duration with the interventional group carrying a glass of water on a tray. Research Hypothesis states that motor dual task training will be more effective than conventional balance exercises on balance and quality of life in elderly fallers. 
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