| 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
|
|
|
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
|
|
|
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
|