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临床试验/CTRI/2024/11/076787
CTRI/2024/11/076787进行中(未招募)不适用

Comparative efficacy of Brain gym exercises and Computerized game based training on cognitive development in patients with Parkinsons Disease

Krittika Pal1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年11月23日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
40
试验地点
1
主要终点
1. Cognition

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
40.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Both male and female genders between ages 40-80 years
  • The patient should be in Modified Hoehn and Yahr classification scale I-III
  • Patient should be independent for ambulation.

排除标准

  • Dependent mobility
  • Subjects with other neurological, musculoskeletal, and associated disorders and cognitive alterations that could interfere with the evaluation process were excluded from the study
  • Subjects having contractures or deformity.

结局指标

主要结局

1. Cognition

时间窗: 2 times - on Day 0 and after 4 weeks of intervention

2. Quality of Life

时间窗: 2 times - on Day 0 and after 4 weeks of intervention

次要结局

未报告次要终点

研究者

发起方
Krittika Pal
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Krittika Pal

The West Bengal University of Health Sciences

研究点 (1)

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