| 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
|
|
|
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
|
|
|
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. |