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CTRI Number  CTRI/2025/10/095839 [Registered on: 09/10/2025] Trial Registered Prospectively
Last Modified On: 09/10/2025
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   Improving Movement and Brain Function in People with Parkinson’s Disease Using Sensory Motor Rhythm Neurofeedback Training and Brainobics 
Scientific Title of Study   Efficacy of Sensory Motor Rhythm Neurofeedback Training and Brainobics in patients with Parkinsons 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  Dr Varun Kalia 
Designation  Associate Professor 
Affiliation  Lovely Professional University 
Address  Block 3, Room 105, Department of Physiotherapy, School of Allied Medical Sciences, Jalandhar - Delhi G.T. Road, Phagwara, Punjab, INDIA

Jalandhar
PUNJAB
144411
India 
Phone  8360374990  
Fax    
Email  varun.26576@lpu.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Varun Kalia 
Designation  Associate Professor 
Affiliation  Lovely Professional University 
Address  Block 3, Room 105, Department of Physiotherapy, School of Allied Medical Sciences, Jalandhar - Delhi G.T. Road, Phagwara, Punjab, INDIA

Jalandhar
PUNJAB
144411
India 
Phone  8360374990  
Fax    
Email  varun.26576@lpu.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Varun Kalia 
Designation  Associate Professor  
Affiliation  Lovely Professional University 
Address  Block 3, Room 105, Department of Physiotherapy, School of Allied Medical Sciences, Jalandhar - Delhi G.T. Road, Phagwara, Punjab, INDIA

Jalandhar
PUNJAB
144411
India 
Phone  8360374990  
Fax    
Email  varun.26576@lpu.co.in  
 
Source of Monetary or Material Support  
Lovely Professional University, Jalandhar - Delhi G.T. Road, Phagwara, Punjab (India) - 144411 
 
Primary Sponsor  
Name  Dr Varun Kalia 
Address  Block 3, Room 105, Department of Physiotherapy, School of Allied Medical Sciences, Jalandhar - Delhi G.T. Road, Phagwara, Punjab, INDIA 
Type of Sponsor  Other [Private University ] 
 
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 Suresh Mani  Lovely Professional University  Block 3, Room 105, Department of Physiotherapy, School of Allied Medical Sciences
Kapurthala
PUNJAB 		 9878331006

suresh.22315@lpu.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Lovely Professional University (IEC-LPU)  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  Brainobics  The Brainobics Exercises will be performed 3 days per week for total of eight weeks, and each session lasting 60 minutes. These exercises include Dual-Task Training (20 minutes/session) combining walking with cognitive tasks such as counting or solving math problems; Obstacle Navigation with Cognitive Engagement (10 minutes/session) involving navigation through hurdles while solving puzzles or recalling sequences; and Structured Cognitive-Motor Games like Wii Fit-based tasks (15-20 minutes/session) to improve hand-eye coordination and balance. Additional components include Quadrato Motor Training (QMT) (10 minutes/session) for motor planning and memory tasks and Aerobic-Cognitive Integration (10 minutes/session) combining cycling with mental tasks. To enhance upper limb coordination and hand motor skills, exercises like In-Hand Manipulation (10 minutes/session), Finger Isolation Tasks (10 minutes/session), Dynamic Dexterity Movements (15 minutes/session), and Handwriting Exercises (10 minutes/session) are included, progressing in complexity over time. Conventional Treatment is also provided to support motor, balance, and cognitive functions. 
Comparator Agent  CONVENTIONAL PHYSIOTHERAPY MANAGEMENT  The conventional physiotherapy management will be performed 3 days per week for total of eight weeks, and will include Balance and Gait Training (e.g., single-leg stands, tandem walking, step-up exercises) performed in 2 sets of 8-10 repetitions, progressing to uneven surfaces as balance improves. Cognitive-Motor Integration exercises (10-15 minutes/session) involve dual-task activities such as walking while solving arithmetic problems or naming objects (Tan et al., 2009). Upper Limb Coordination and Dexterity Training (10 minutes/session) focuses on threading beads, gripping objects, and practicing buttoning, progressing to more intricate tasks. Dance Therapy (20-30 minutes/session) includes rhythmic movements and multitasking, with routines advancing in complexity. Finally, Aerobic and Resistance Training combines 20 minutes/session of aerobic activity (e.g., cycling) with 2 sets of 8-12 repetitions for resistance exercises, with gradual intensity increases. 
Intervention  SMR Neurofeedback Training  SMR Neurofeedback Training for 3 days per week for eight weeks, and each session lasting 60 minutes. Electrodes are placed on the C3 and C4 regions of the motor cortex, referenced to mastoid electrodes, while subjects remain seated comfortably. Training involves multiple 5-minute rounds where real-time visual feedback is displayed as a bar graph. Subjects are rewarded for maintaining SMR activity within the 22-30 Hz frequency range for a minimum of 250 ms.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Clinically diagnosed patients of Parkinson Disease. (Hoehn and Yahr stages I-III).
Aged between 40-80 years.
Both male or female.
Stable medication regimens for at least 8 weeks
Able to provide informed consent
 
 
ExclusionCriteria 
Details  Significant comorbid neurological or psychiatric disorders.
History of seizures.
Received treatment with neurofeedback or cognitive-motor therapy within the last 6 months.
Uncooperative behavior.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Unified Parkinson’s Disease Rating Scale (UPDRS part III) to access the Motor Function
2. Montreal Cognitive Assessment (MoCA) to access the Cognitive Function
3. Berg Balance Scale (BBS) to access the Balance.
4. Box and Blocks Test for manual dexterity and the Nine-Hole Peg Test for fine motor skills and coordination (to access theUpper Limb Coordination).
 		 Baseline, 8 week and 12 week.  
 
Secondary Outcome  
Outcome  TimePoints 
Parkinson’s Disease Questionnaire (PDQ-39).  Baseline, 8 week & 12 week.  
 
Target Sample Size   Total Sample Size="51"
Sample Size from India="51" 
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)   03/11/2025 
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="2"
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  
This research investigates the efficacy of Sensory Motor Rhythm (SMR) Neurofeedback Training with and without Brainobics in patients with Parkinson’s Disease through a randomized clinical trial. It aims to enhance motor, cognitive, balance, and coordination functions by targeting neuroplasticity using non-invasive interventions. The study compares outcomes across neurofeedback, combined brainobics, and conventional physiotherapy groups, addressing limitations of pharmacological treatments and exploring innovative rehabilitation strategies to improve quality of life. This randomized clinical trial aims to evaluate the efficacy of Sensory Motor Rhythm (SMR) Neurofeedback Training with and without Brainobics in patients with Parkinson’s disease, a progressive neurodegenerative disorder that impairs both motor and cognitive functions. While pharmacological therapies such as levodopa provide symptomatic relief, they are associated with long-term side effects and do not modify disease progression, highlighting the need for innovative non-pharmacological strategies. SMR Neurofeedback, which uses EEG-based real-time feedback at C3 and C4 electrode placements to train patients in maintaining sensorimotor rhythm activity, has shown promise in improving motor control and cognition. Brainobics, a structured program combining dual-task exercises, obstacle navigation, cognitive-motor games, Quadrato Motor Training, aerobic-cognitive integration, and fine motor/upper limb dexterity tasks, is designed to enhance neuroplasticity, balance, coordination, and cognitive flexibility. In this study, 51 subjects with clinically diagnosed Parkinson’s disease (Hoehn and Yahr stages I–III) will be randomly allocated into three groups: Group 1 will receive SMR Neurofeedback training along with conventional physiotherapy (3 sessions/week, 60 minutes each, for 8 weeks), Group 2 will receive a combined protocol of SMR Neurofeedback and Brainobics along with conventional physiotherapy on alternate days for 8 weeks, and Group 3 will undergo conventional physiotherapy management alone for 8 weeks. Outcomes will be measured using the Unified Parkinson’s Disease Rating Scale (UPDRS-III), Montreal Cognitive Assessment (MoCA), Berg Balance Scale, Box and Block Test, Nine-Hole Peg Test, and Parkinson’s Disease Questionnaire (PDQ-39). The findings are expected to generate evidence-based insights on the individual and synergistic effects of SMR Neurofeedback and Brainobics, potentially offering safe, cost-effective, and scalable rehabilitation options to improve motor and cognitive functions, quality of life, and functional independence in individuals with Parkinson’s disease.
 
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