Exergaming for Improving Upper Limb Functions in Parkinson's Disease

Official title

Exergaming With Physical Objects for Upper Limb Rehabilitation in Parkinson's Disease: Effects on Functional Outcome

Overview

Parkinson's Disease commonly results in impaired hand dexterity, reducing a patient's ability to perform activities of daily living. While digital exergaming has been used to encourage physical activity and improve motor function, it often lacks real-world tactile engagement. Integrating physical objects into exergaming known as a phygital approach which may enhance sensorimotor learning and functional carryover. However, its impact on upper limb functional outcomes in PD remains underexplored. Objectives: To assess the effectiveness of exergaming with physical objects on functional outcomes of upper limb rehabilitation in individuals with Parkinson's Disease. Methodology: This randomized controlled pilot study will include 30 individuals with early-stage Parkinson's Disease, recruited through convenience sampling and randomly assigned to either a phygital exergaming group or a control group. Both groups will receive sessions over three monthd (3 sessions/week, 30 minutes each). The phygital group will perform task-based exergaming using both physical objects and digital prompts, while the control group will use digital prompts alone. Functional outcomes will be assessed using the Box and Block Test (BBT), at baseline (day 1) and post intervention 12 weeks. Statistical Analysis: Data will be analyzed using SPSS version 25. Descriptive statistics like gender, stages of diseases etc. will be summarized and described as bar charts and percentages. Within-group differences will be assessed using paired t-tests or Wilcoxon signed-rank tests based on data normality. Between-group comparisons will be conducted using independent t-tests or Mann-Whitney U tests. A p-value of less than 0.05 will be considered statistically significant.

Detailed description

Upper limb motor impairments in Parkinson's Disease significantly affect daily functioning and independence . While digital exergaming has emerged as a promising tool in neurorehabilitation, traditional models often rely solely on screen-based interaction and lack real-world physical engagement. Recent studies have highlighted the need to include tactile and sensory feedback to improve functional relevance and user experience. Integrating physical objects into exergames referred to as a "phygital" approach, enhances realism, encourages multisensory stimulation, and may result in better motor learning and functional outcomes.

After the selection of subjects as per the guideline of university ethical review board. Informed consent will be taken from each participant. Participants who meet the inclusion criteria and provide informed consent will be assigned to one of two groups (30 per group) Data collection will occur in private examination rooms to ensure privacy and minimize distractions during assessments. Measures will be taken to maintain participant privacy during assessments and data collection. Data will be collected using Box and Block Test (BBT).

The intervention group (phygital) will receive 36 sessions (three sessions per week over 12 weeks), each lasting approximately 30 minutes, involving structured exergaming tasks using physical objects (e.g., blocks, spoons, cups) combined with digital prompts on a tablet or laptop. Control group B will receive the same session frequency and duration, with identical digital prompts, but without the use of physical objects. While conventional Physical Therapy will be given to all the subjects of both groups. All sessions will be conducted under the supervision of a physiotherapist in a controlled clinical environment. Data will be collected at two points: baseline (pre-intervention), immediately after the 6-weeks intervention. Outcome measures will include the Box and Block Test (BBT) for gross manual dexterity.

Data shall be collected through an assessor who will be blinded to the patient group to minimize biases.

Data will be analyzed using IBM SPSS version 25. Descriptive Statistics shall be used to summarize demographics and clinical characteristics (e.g., age, gender, P.D. stage) and shall be presented as means, standard deviations, frequencies, and percentages. Data will be visualized using bar charts and tables. Within group comparisons will be performed to assess pre- and post-intervention changes using the paired t-test for data that meet assumptions of normality. If the data are non-normally distributed, the Wilcoxon signed-rank test will be used as a non-parametric alternative. For between-group comparisons, the independent t-test will be applied to compare outcomes between the intervention and control groups when data are normally distributed, while the Mann-Whitney U test will be used for non-parametric data.

Independent sample t test will be used for comparison of hand motor movements between. A p-value ≤ 0.05 will be considered as significant.

Interventions

• Combination product Exergaming
  The intervention group (phygital) will receive 36 sessions (three sessions per week over twelve weeks), each lasting approximately 30 minutes, involving structured exergaming tasks using physical objects (e.g., blocks, spoons, cups) combined with digital prompts on a tablet or laptop.
• Procedure Conventional Physical Therapy
  Patients will receive routine physiotherapy treatment based on the impairments: Strength Training Flexibility and Mobility Balance and Coordination Gait and Functional Training Conentional Physical Therapy

Primary outcome measures

• Box and Block Test [Time frame: Baseline Measurements at day 1 will be taken prior to the interventions, and late Post-treatment after 12 weeks of intervention, another assessment will be taken. At followup visits, the consistency in the improvement will be assessed.]

Eligibility criteria

Inclusion criteria

• Early-stage Parkinson's Disease from I-III of Hoehn and Yahr scale
• Cognitinve Assessment MMSE >= 24 Score
• Able to communicate and understand the commands
• Must be on regular use of Levodopa/carbidopa

Exclusion criteria

• Advanced stage IV or V
• Patients with severe cognitive deficits.
• History of suffering from other neurological or musculoskeletal conditions affecting hand use for the exercise
• Not taking any medicine for systemic illness

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Pakistan · 1 center

• Punjab institute of Neuroscience Lahore — Lahore

Identifiers

NCT: NCT07475741 · UHS/DPS-25/1158

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗