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CTRI Number  CTRI/2024/07/070951 [Registered on: 22/07/2024] Trial Registered Prospectively
Last Modified On: 19/07/2024
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 dual task training on motor and cognitive functions in patients with Parkinsons disease  
Scientific Title of Study   Impact of dual task training on cognitive function, balance, gait and quality of life in patients with Parkinson’s disease 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Monika 
Designation  PG student 
Affiliation  College of Physiotherapy, PGIMS, Rohtak 
Address  Physiotherapy Department, E block, College of Physiotherapy, PGIMS, Rohtak, HARYANA,124001, India

Rohtak
HARYANA
124001
India 
Phone  9896292418  
Fax    
Email  monuchhimpa2000@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dimple Choudhry 
Designation  Assistant Professor  
Affiliation  College of Physiotherapy, PGIMS, Rohtak 
Address  Physiotherapy Department, Teaching staff room, E block, College of Physiotherapy, PGIMS, Rohtak, HARYANA,124001, India

Rohtak
HARYANA
124001
India 
Phone  9416666445  
Fax    
Email  dimplephysio80@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Dimple Choudhry 
Designation  Assistant Professor  
Affiliation  College of Physiotherapy, PGIMS, Rohtak 
Address  Physiotherapy Department, Teaching staff room, E block, College of Physiotherapy, PGIMS, Rohtak, HARYANA,124001, India

Rohtak
HARYANA
124001
India 
Phone  9416666445  
Fax    
Email  dimplephysio80@gmail.com  
 
Source of Monetary or Material Support  
Pt. B. D. Sharma, PGIMS, Rohtak, Haryana, India, 124001 
 
Primary Sponsor  
Name  College of Physiotherapy, PGIMS, Rohtak 
Address  Pt. B . D. Sharma, PGIMS, Rohtak, Haryana, India, 124001 
Type of Sponsor  Government 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 Dimple Choudhry  Pt. B. D. Sharma, PGIMS  Neurology OPD and Physiotherapy Department, E-Block, college of Physiotherapy, Pt. B. D. Sharma, PGIMS/UHS, Rohtak HARYANA
Rohtak
HARYANA 		 9416666445

dimplephysio80@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical Research Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G20||Parkinsons disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dual task training   Dual task training -12-meter walking with verbal instructions of “walk to the end of the walkway at comfortable pace, count backwards by threes” until I tell you to stop start with a beginning number, Tandem standing with remembering shapes, Tandem walking with backward counting, Backward walking with naming objects i.e.(Table, Chair, Pen etc.) Dosimetry-Each task done for 3 times with 1 min rest in between task and 2 min rest after each task for 12 Session (2 session/ week) for 6 weeks  
Comparator Agent  Single task training   Single task training-Include motor task like-12-meter walking with verbal instructions of “walk to the end of the walkway at comfortable pace”, Tandem standing, Tandem walking, Backward walking. Dosimetry-Each task done for 3 times with 1 min rest in between task and 2 min rest after each task for 12 Session (2 session/ week) for 6 weeks  
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients diagnosed with idiopathic Parkinson’s disease by neurologist.
Patients able to walk for 12m without assistance.
 
 
ExclusionCriteria 
Details  1.Severe mental retardation
2.History of intracranial surgery
3.History of traumatic brain injury
4.History of visual and hearing defect 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Time up and go test, gait parameters (step length, stride length), fluency test , Parkinson’s disease questionnaire-39  Baseline, 3 Weeks After post-Intervention, 6 Weeks After post-Intervention
 
 
Secondary Outcome  
Outcome  TimePoints 
Parkinsons disease questionnaire-39  Baseline, 3 Weeks After post-Intervention, 6 Weeks After post-Intervention 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/08/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   In this is a experimental study design Impact of dual task training is check on patients with Parkinson’s disease. Patients divided into two group experimental (n=15) and control group (n=15) in which dual task training and single task training will be given respectively. Outcome measure used are  time up and go test, gait parameters (step length, stride length), fluency test , Parkinson’s   disease questionnaire to assess balance, gait parameters ,cognition, quality of life respectively. After the pre-test assessment experimental group will be provided with 12 sessions (each session will be of 40 minutes, conducted twice a week for 6 weeks) of dual task training and control group will be provided with  12 sessions (each session will be of 40 minutes, conducted twice a week for 6 weeks) of Single task training. This study explore the Impact of dual task training on cognitive function, balance, gait and quality of life in patients with Parkinson’s disease. 
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