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CTRI Number  CTRI/2024/11/076787 [Registered on: 14/11/2024] Trial Registered Prospectively
Last Modified On: 09/03/2026
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 clinical trial to compare the effects of Brain exercises and Computerized game-based training in Parkinsons patients 
Scientific Title of Study   Comparative efficacy of Brain gym exercises and Computerized game based training on cognitive development 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  Krittika Pal 
Designation  Post Graduate Student 
Affiliation  The West Bengal University of Health Sciences 
Address  Nopany Physiotherapy Clinic, Ground floor, Nopany Institute of Healthcare Studies, 2C, Nando Mullick Lane, Girish Park, Kolkata

Kolkata
WEST BENGAL
700006
India 
Phone  9831141625  
Fax    
Email  krittikapal1999@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Namita Kaushik 
Designation  Assistant Professor 
Affiliation  The West Bengal University of Health Sciences 
Address  Nopany Physiotherapy Clinic, Ground floor, Nopany Institute of Healthcare Studies, 2C, Nando Mullick Lane, Girish Park, Kolkata

Kolkata
WEST BENGAL
700006
India 
Phone  9874144749  
Fax    
Email  namitakausshik93@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Anwesh Pradhan 
Designation  Associate Professor 
Affiliation  The West Bengal University of Health Sciences 
Address  Nopany Physiotherapy Clinic, Ground floor, Nopany Institute of Healthcare Studies, 2C, Nando Mullick Lane, Girish Park, Kolkata

Kolkata
WEST BENGAL
700006
India 
Phone  9932874589  
Fax    
Email  anweshpradhan696@gmail.com  
 
Source of Monetary or Material Support  
Nopany Institute of Healthcare Studies, Nando Mullick Lane, Kolkata, West Bengal, PIN- 700006 
 
Primary Sponsor  
Name  Krittika Pal 
Address  Nopany Institute of Healthcare Studies, 2C, Nando Mullick Lane, Girish Park, Kolkata, West Bengal, PIN - 700006 
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 Krittika Pal  Nopany Institute of Healthcare Studies  Nopany Physiotherapy Clinic, Ground floor, Nopany Institute of Healthcare Studies, 2C, Nando Mullick Lane, Girish Park, Kolkata
Kolkata
WEST BENGAL 
9831141625

krittikapal1999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Nopany Institute of Healthcare Studies 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  BRAIN GYM EXERCISES  This group will receive only brain gym exercises for 30 minutes thrice a week for 4 weeks. 
Comparator Agent  COMPUTERIZED GAME-BASED TRAINING  This group will receive computer-based cognitive training. The session will continue for 30 minutes thrice a week for 4 weeks.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Both male and female genders between ages 40-80 years
2. The patient should be in Modified Hoehn and Yahr classification scale I-III
3. Patient should be independent for ambulation  
 
ExclusionCriteria 
Details  1. Dependent mobility
2. Subjects with other neurological, musculoskeletal, and associated disorders and cognitive alterations that could interfere with the evaluation process were excluded from the study
3. Subjects having contractures or deformity
 
 
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. Cognition
2. Quality of Life 
2 times - on Day 0 and after 4 weeks of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  N/A 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   23/11/2024 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

PURPOSE OF THE STUDY:

Non-motor symptoms have a greater impact on quality of life compared to motor symptoms in Parkinson’s Disease, and the conventional treatment, which includes antiparkinsonian drugs, is largely ineffective at alleviating non-motor symptoms, particularly those related to cognitive abilities.

BG is sometimes more pleasant for older adults who tend not to participate in conventional exercises and also has a positive effect on cognitive function.

Previous research indicated that solely those patients who underwent computerized training exhibited an improvement in the progression of cognitive deterioration. Conversely, those who were only provided with motor rehabilitation displayed a tendency to deteriorate as time passed. 

Therefore, an interest developed that which technique would be more helpful in improving cognition in patients with Parkinson’s disease. 

So, to compare the efficacies between brain gym exercises and computerized-based training on the cognitive domain in patients with Parkinson’s Disease, this study was needed to be conducted.

 

AIM OF THE STUDY:

The study aimed to compare the efficacy between Brain Gym Exercises and Computerized Game-based training on cognitive development in patients with Parkinson’s Disease.

 

OBJECTIVES:

1. To check whether brain gym exercises could improve cognition in patients with Parkinson’s Disease

2. To find out whether Computerized Game-based training could improve cognition in patients with Parkinson’s Disease.

3. To compare brain gym exercises and Computerized Game-based training on cognitive development in patients with Parkinson’s Disease.

 

NULL HYPOTHESIS:

There will be no significant difference between the efficacies of brain gym exercise and computerized game-based training on cognitive development in patients with Parkinson’s Disease.

 

ALTERNATE HYPOTHESIS:

There will be a significant difference between the efficacies of brain gym exercise and Computerized Game-based training on cognitive development in patients with Parkinson’s Disease.

 

MATERIALS AND METHODS:

A total of 36 participants who met the predefined inclusion and exclusion criteria were enrolled in this randomized controlled trial. The intended sample size was 40, but only 36 participants qualified. Participants were randomly allocated into two groups— Group A (Brain Gym Exercise) and Group B (Computerized Game-based Exercise)— using the toss method. Allocation was performed after enrollment and consent by the toss method. Prior to intervention, each participant received a detailed explanation of the study protocol. Written informed consent was obtained from all participants. The study commenced only after signed consent forms were collected. Interventions were administered during the participants’ ‘ON-phase’—approximately one hour after intake of antiparkinsonian medication to ensure optimal motor function during sessions. Both groups received their respective interventions over a 4-week period. Baseline assessments were conducted on Day 1 and post-intervention assessments were completed on Day 14 in the 4th week. Cognitive function was measured using the Montreal Cognitive Assessment and quality of life was evaluated using the Parkinson’s Impact Scale. During the study, 7 participants withdrew (Group A: 3; Group B: 4) and 6 were unable to complete the intervention (Group A: 1; Group B: 5). The final analysis included 23 participants which are 14 in Group A and 9 in Group B.

STATISTICAL ANALYSIS:

The statistical analysis was conducted using SPSS software version 25. The primary analysis used descriptive statistics to analyse the demographic data and the patient score. Pre (baseline) and post (after 4 weeks) intervention data were collected and analysed. The treatment effect within the groups was measured separately using paired t-test. Independent sample t-test was used to analyse the difference between the effect of Group A (Brain Gym exercises) and Group B (Computerized Game based training ). A significance threshold of p<0.05 was determined.

RESULTS:

The analysis of the results showed both BG exercises (Group A) and CGBT (Group B) led to statistically significant changes in cognitive function (p < 0.05) as indicated by the increase in MoCA scores (p< 0.05), whereas the shift observed in Group B was not statistically significant (p > 0.05). Between-group comparisons showed no significant differences in post-intervention mean differences for either cognition or quality of life (p > 0.05). The study accepts the null hypothesis, as no significant differences were found between the two groups in either cognitive or quality of life, indicating that both approaches are similarly effective in enhancing cognition among individuals with Parkinson’s disease.

CONCLUSION:

Both Brain Gym (BG) and computerized cognitive training (CGBT) produced comparable short-term improvements in cognitive function in individuals with Parkinson’s disease, while BG additionally enhanced quality of life, likely due to its movement-based and psychosocial benefits. These findings support the use of individualized, non-pharmacological cognitive rehabilitation approaches based on patient preference, physical ability, and accessibility, with potential value in combining or alternating methods to sustain engagement. However, interpretation is limited by the small sample size, short intervention duration, absence of a no-treatment control group, and variability in cognitive profiles. Future research should involve larger samples, longer follow-up periods, inclusion of control groups, and exploration of combined or multimodal interventions across Parkinson’s disease and other neurological conditions to determine long-term and broader therapeutic benefits.

 

 
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