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CTRI Number  CTRI/2025/12/099475 [Registered on: 19/12/2025] Trial Registered Prospectively
Last Modified On: 19/12/2025
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   A study on how walking backwards on a treadmill affects balance and thinking skills in people with parkinsons disease 
Scientific Title of Study   Effect of Treadmill Based Backward Walking training on Postural Control and Cognitive Function In Individuals with Parkinsons Disease 
Trial Acronym  TBWALK-PD 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Namathota Chandra Akshay Kumar 
Designation  PhD Scholar 
Affiliation  Manipal College of Health Professions 
Address  Department of physiotherapy ,Manipal College of Health Professions, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104

Udupi
KARNATAKA
576104
India 
Phone  9739594943  
Fax    
Email  namathota.mchpmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Manikandan Natarajan 
Designation  Professor HOD 
Affiliation  Manipal College of Health Professions 
Address  Department of physiotherapy ,Manipal College of Health Professions, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104

Udupi
KARNATAKA
576104
India 
Phone  9886898064  
Fax    
Email  mani.kandan@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Apoorva Malavalli 
Designation  Assistant Professor  
Affiliation  Manipal College of health professions 
Address  Manipal College of Health Professions, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104

Udupi
KARNATAKA
576104
India 
Phone  9591976213  
Fax    
Email  apoorva.s@manipal.edu  
 
Source of Monetary or Material Support  
Department of physiotherapy,Manipal college of health professions  
 
Primary Sponsor  
Name  Namathota Chandra Akshay Kumar 
Address  Manipal College of Health Professions, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104 
Type of Sponsor  Other [Self] 
 
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 Apoorva Malavalli  Kasturba Hospital, Manipal  Baliga block,N1,Department of physiotherapy,Kasturba Hospital, Manipal-576104
Udupi
KARNATAKA 		 9591976213

apoorva.s@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional 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 
Comparator Agent  Standard therapy  Flexibility training,postural Stability and balance training,transitions, gait training with cueing  
Intervention  Treadmill-based Backward walking training  The treatment will be conducted during the on-phase of levodopa medication. Warm-up, consisting of light stretching and mobility of the trunk and the limbs will be given. The investigator will provide detailed instructions and a demonstration of backward walking on the treadmill. Participants’ vital parameters and exertion level will be assessed using a 15-point Rating of Perceived Exertion (RPE) scale. Participants will be made to stand on the treadmill, supported using a bodyweight harness, and use the handrails for support. Safety switch is attached to the harness and a trial of backward walking given. Participants will be asked to walk backward on the treadmill, starting with the speed calculated prior (5% the speed from 3-meter BWT) and gradually, the speed is increased to a moderate level of exertion (13 out of 20 in RPE scale). During the entire training session, blood pressure, heart rate, and rate of perceived exertion will be monitored. Participants are permitted to take breaks if they experience any discomfort. Post walking, participants are allowed to rest till vital parameters and RPE reach baseline. Following the session, participants will be asked to visit the center after a day of rest. The BWT training will be provided for 45 minutes to one hour per session per day for 2-3 days a week. A minimum of one day’s rest will be provided after the intervention session. The number of treatment sessions will be approximately 12, over a course of 4 to 6 weeks. 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1 People with Parkinson’s disease who are ambulatory
2 Intact cognition (Montreal Cognition Assessment score (MoCA greater than 26)  
 
ExclusionCriteria 
Details  1 Severe fall risk (Pull test less than 2)
2 Severe motor fluctuations or Severe dyskinesia (less than grade 2)
3 Levodopa Equivalent Daily Dose variations in the last one month
4 Impairment of vision, hearing, or speech as documented in their medical records
or mentioned by caregivers
5 Individuals undergoing Deep Brain Stimulation
6 Physician-determined major medical problems such as musculoskeletal diseases, severe osteoarthritis, peripheral neuropathy, joint replacement that would affect the ability to walk
7 Deficits of somatic sensation involving the lower limbs
8 Vestibular disorders or paroxysmal vertigo
9 Cardiovascular comorbidities like recent myocardial infarction, heart failure, uncontrolled hypertension, and orthostatic hypotension
10 Signs of autonomic dysfunction
11 Other neurological conditions 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Postural control will be assessed in terms of balance using limits of stability test and Rombergs test, whole gait will be assessed in terms of distance walked in six minutes, average speed of walking, number of steps, step width, and gait symmetry
Cognitive function: Timed-up and Go test-cognition and Stroop test.
 		 3(Baseline, Post intervention and follow up) 
 
Secondary Outcome  
Outcome  TimePoints 
Balance confidence: Activities Specific Balance Confidence (ABC) scale   3(Baseline, Post intervention and follow up) 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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/ Phase 2 
Date of First Enrollment (India)   01/01/2026 
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="3"
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   Backward walking training, if found effective in improving postural control and cognition, could become a routine rehabilitation strategy for individuals with Parkinson’s disease. Incorporating treadmill-based backward walking may reduce fall risk, enhance cognitive function, and stimulate alternative neural pathways, offering distinct benefits beyond conventional gait training. Clinicians can use this approach to improve adaptability to dynamic environments, promote independence in daily activities, and ultimately enhance the quality of life for individuals with Parkinson’s disease. 
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