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CTRI Number  CTRI/2026/01/100553 [Registered on: 08/01/2026] Trial Registered Prospectively
Last Modified On: 07/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Efficacy of treadmill training and dual task cognition for freezing of gait in patients with parkinson’s disease 
Scientific Title of Study   Efficacy of treadmill training and dual task cognition for freezing of gait in patients with parkinson’s disease : Randomized controlled 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  Disha Vikas Patil 
Designation  Undergraduate Student 
Affiliation  Dr APJ Abdul Kalam College Of Physiotherapy  
Address  Dr APJ Abdul Kalam College Of Physiotherapy, Pravara Institute of Medical Sciences, Loni Maharashtra
J8R Kulkarni garden back, Sharanpur Rd, Racca Colony, Jejurkar Wadi, Sharanpur, Nashik, Maharashtra 422002
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  7756040885  
Fax    
Email  dishapatil0611@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shyam Kurapati 
Designation  HOD Neuro Physiotherapy Department 
Affiliation  Dr APJ Abdul Kalam College Of Physiotherapy 
Address  Dr APJ Abdul Kalam College Of Physiotherapy, Pravara Institute of Medical Sciences, Loni Maharashtra

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  8978438484  
Fax    
Email  kurapatishyam82@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shyam Kurapati 
Designation  HOD Neuro Physiotherapy Department 
Affiliation  Dr APJ Abdul Kalam College Of Physiotherapy 
Address  Dr APJ Abdul Kalam College Of Physiotherapy, Pravara Institute of Medical Sciences, Loni Maharashtra


MAHARASHTRA
413736
India 
Phone  8978438484  
Fax    
Email  kurapatishyam82@gmail.com  
 
Source of Monetary or Material Support  
303 OPD Neuro Physiotherapy Department Dr APJ Abdul Kalam College Of Physiotherapy PIMS (DU) Loni Ahmednagar Maharashtra 413736 India 
 
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 = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Disha Vikas Patil  Arihant Neurocenter  J8R Kulkarni Garden Back Sharanpur Road Racca Colony Jejurkar Wadi Sharanpur Nashik Maharashtra 422002
Nashik
MAHARASHTRA 
7756040885

dishapatil0611@gmail.com 
Disha Vikas Patil  Dr APJ Abdul Kalam College Of Physiotherapy   303 OPD Dr APJ Abdul Kalam College Of Physiotherapy Loni Ahmednagar
Ahmadnagar
MAHARASHTRA 
7756040885

dishapatil0611@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical 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  Conventional   Participants in conventional will receive standard physiotherapy for gait for a period of eight weeks with sessions conducted three days per week and each session lasting approximately forty five minutes This intervention will focus on improving lower limb strength balance and functional mobility The physiotherapy program will include static and dynamic balance training obstacle negotiation activities lower limb strengthening exercises targeting major muscle groups of the legs and specific gait training exercises aimed at improving stride length cadence and overall walking quality 
Comparator Agent  Experimental   Participants in experimental group will receive cognitive training combined with treadmill therapy for a duration of eight weeks with sessions conducted three days per week Each session will involve thirty to forty five minutes of treadmill walking during which participants will simultaneously perform cognitive tasks This dual task approach is designed to engage physical movement along with mental processing with the aim of improving gait pattern reducing freezing episodes and enhancing cognitive performance The cognitive activities performed during walking will include word retrieval tasks such as recalling or classifying words simple arithmetic tasks such as basic addition or subtraction and auditory or visual tasks that require responding to sounds or identifying colors or objects 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Medically diagnosed staged Parkinsons Disease Hoehn and Yahr stage one to four
Age between fifty and eighty years
Able to follow instructions and perform physical exercises
Patients with at least one episode of freezing of gait in the past six months to one year depending on the timeline of diagnosis
Written informed consent
Patient should be able to walk independently 
 
ExclusionCriteria 
Details  Severe cardiovascular or musculoskeletal disorders
Recent surgeries or fractures
Cognitive impairments that prevent participation in cognitive training tasks
Uncontrolled medical conditions or psychiatric disorders
Patients confined to bed or wheel chair stage five
Seizures
Pregnancy
Parkinsonism
 
 
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 
Body structure and function MDS UPDRS part three MDS UPDRS part one
Activity six minute walk Montreal Cognitive Assessment nine hole peg test
Freezing of gait Freezing of Gait questionnaire
Dual task Timed Up and Go 
week 0-week 8 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   20/01/2026 
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 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  
As Parkinsons Disease progresses individuals experience significant mobility limitations with freezing of gait emerging as one of the most disabling symptoms Despite advances in pharmacological management freezing of gait remains poorly controlled particularly in the advanced stages of the disease Non pharmacological interventions such as treadmill therapy and dual task cognitive training have demonstrated potential benefits in improving gait and motor performance in individuals with Parkinsons Disease however limited research has specifically focused on patients with advanced Parkinsons Disease This study aims to address the existing lack of evidence regarding the combined effects of treadmill therapy and dual task cognitive training on freezing of gait in patients with advanced Parkinsons Disease and the findings may provide valuable insights into effective rehabilitation strategies that can enhance independence and improve overall quality of life 
MATERIAL AND METHODOLOGY The study will be conducted as an interventional study with data collected from Dr Vitthalrao Vikhe Patil Pravara Rural Hospital Loni and Arihant Neuro Centre Nashik using a sample size of twenty participants selected through simple random sampling over a duration of one year Participants will include patients diagnosed with Parkinsons Disease The materials used for the study will include the Freezing of Gait Severity Scale Montreal Cognitive Assessment Unified Parkinsons Disease Rating Scale Hoehn and Yahr scale consent form assessment form and treadmill 
INTERVENTION  Participants will be divided into two groups 
Group A will receive cognitive training combined with treadmill therapy for eight weeks three days per week with each session lasting thirty to forty five minutes during which participants will perform cognitive tasks simultaneously with walking This integrated approach is intended to address both motor and cognitive components with the goal of improving walking pattern reducing freezing episodes and enhancing cognitive performance The cognitive tasks will include word retrieval activities such as recalling or classifying words basic arithmetic tasks such as simple addition or subtraction and auditory or visual tasks requiring responses to sounds or identification of colors or objects 
Group B will receive standard physiotherapy focused on gait for eight weeks three days per week with each session lasting forty five minutes This intervention will aim to improve lower limb strength balance and functional mobility and will include balance training using static and dynamic activities obstacle negotiation tasks lower limb strengthening exercises targeting major muscle groups such as the quadriceps hamstrings and calves and gait training exercises to improve stride length cadence and smoothness of walking


 
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