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Exergaming With Physical Objects for Upper Limb Rehabilitation in Parkinson's Disease (NCT07475741)
Exergaming With Physical Objects for Upper Limb Rehabilitation in Parkinson's Disease
Clinical Trial Identifier: [NCT07475741](https://clinicaltrials.gov/study/NCT07475741)
Overview
Exergaming With Physical Objects for Upper Limb Rehabilitation in Parkinson's Disease
Clinical Trial Identifier: [NCT07475741](https://clinicaltrials.gov/study/NCT07475741)
Overview
Parkinson's disease (PD) affects millions of people worldwide, causing progressive motor dysfunction including tremor, bradykinesia, rigidity, and postural instability. While much attention focuses on gait and balance, upper limb dysfunction—manifesting as decreased manual dexterity, reduced grip strength, and impaired coordination—significantly impacts daily activities like writing, dressing, eating, and using electronic devices["@yang2022"].
This clinical trial investigates a novel "phygital" (physical + digital) rehabilitation approach combining exergaming with physical objects to improve upper limb function in Parkinson's disease patients. The study is conducted by the University of Health Sciences Lahore at the Punjab Institute of Neuroscience["@exergaming"].
Study Details
| Field | Value |
|-------|-------|
| NCT Number | NCT07475741 |
| Phase | Not Applicable |
| Status | Recruiting |
| Sponsor | University of Health Sciences Lahore |
| Lead Investigator | Hafiz Muddassir Riaz, Ph.D Scholar (Lecturer) |
| Enrollment | 30 participants |
| Start Date | February 20, 2026 |
| Est. Primary Completion | September 2026 |
| Est. Study Completion | November 2026 |
| Location | Lahore, Pakistan |
| Study Type | Interventional |
| Allocation | Randomized controlled trial |
| Intervention Model | Parallel assignment |
Background and Rationale
The Challenge of Upper Limb Dysfunction in PD
Upper limb impairment in Parkinson's disease presents as:
These deficits lead to:
- Difficulty with self-care activities (dressing, grooming, eating)
- Reduced independence in daily living
- Impaired handwriting (micrographia)
- Reduced quality of life
- Social isolation and depression
Limitations of Current Rehabilitation Approaches
Traditional physical therapy for PD upper limb dysfunction includes:
- Passive and active range of motion exercises
- Strengthening exercises
- Occupational therapy for ADL (activities of daily living) training
- Constraint-induced movement therapy (CIMT)
However, these approaches face limitations:
- Motivation: Traditional exercises can be repetitive and boring
- Adherence: Long-term compliance with home exercise programs is poor
- Objectivity: Hard to measure progress objectively
- Intensity: Difficult to achieve optimal training intensity
- Accessibility: Requires regular clinic visits
The Promise of Exergaming
Exergaming (exercise + gaming) combines physical activity with game-based motivation, offering several advantages[@chen2021]:
- Increased motivation: Games provide intrinsic reward and engagement
- Objective feedback: Score and progress tracking provides immediate feedback
- Optimal challenge: Games can adapt difficulty to maintain optimal challenge
- Increased adherence: Fun and engaging format improves long-term compliance
- Home-based delivery: Can be delivered remotely, increasing accessibility
The Phygital Innovation
This trial introduces a "phygital" approach combining physical objects with digital game-based rehabilitation[@giovanetti2022]:
Physical Objects:
- Real-world objects (blocks, balls, cups) that provide tactile feedback
- Graduated resistance and weight for progressive strengthening
- Familiar objects that translate to daily activities
- Ergonomic design appropriate for PD patients
- Motion tracking sensors capture movement data
- Games respond to physical object manipulation
- Progress tracking and scoring
- Remote monitoring capability
- Combines benefits of physical therapy with gamification
- Maintains tactile, real-world object interaction
- Provides digital tracking of progress
- Bridges clinic-based and home-based rehabilitation
Study Design
This is a randomized controlled trial comparing phygital exergaming with conventional physical therapy.
Trial Structure
| Component | Experimental Arm | Control Arm |
|-----------|-----------------|-------------|
| Intervention | Phygital Exergaming | Conventional Physical Therapy |
| Sessions | 36 sessions over 12 weeks | 36 sessions over 12 weeks |
| Frequency | 3 sessions per week | 3 sessions per week |
| Duration | 30 minutes per session | 30 minutes per session |
| Total Dose | 18 hours | 18 hours |
Experimental Arm: Phygital Exergaming
The phygital exergaming intervention uses specialized software with physical objects:
Physical Objects Used:
Game Components:
- Virtual environments that respond to physical object manipulation
- Progressive difficulty levels
- Score tracking and achievement systems
- Movement quality feedback
Control Arm: Conventional Physical Therapy
Conventional physical therapy includes:
- Passive and active range of motion exercises
- Stretching programs
- Strengthening exercises (isometric and resistive)
- Coordination and dexterity training
- Functional training for ADLs
- Balance and posture exercises
Randomization and Blinding
- Allocation: 1:1 randomization using computer-generated sequence
- Blinding: Outcome assessors blinded to group allocation (single-blind design)
- Blinding limitations: Participants and therapists cannot be blinded due to nature of intervention
Outcome Measures
Primary Endpoints
- Measures gross manual dexterity
- Counts number of blocks transferred between compartments in 60 seconds
- Validated measure with established reliability in PD
- Assessment timepoints: Baseline and 12 weeks post-intervention
- Measures fine motor coordination
- Time to place and remove 9 pegs
- Sensitive to PD upper limb impairment
- Assessment timepoints: Baseline and 12 weeks
Secondary Endpoints
- MDS-UPDRS Part III: Motor examination (bradykinesia subscore)
- Purdue Pegboard Test: Assesses fine motor skill
- Jamar Dynamometer: Grip strength measurement
- Barthel Index: Activities of daily living
- MDS-UPDRS Part II: Motor aspects of daily living
- PDQ-39: Parkinson's Disease Questionnaire-39
- SF-36: Short Form Health Survey
- Adverse events monitoring
- Fall incidence
- Exercise tolerance
Assessment Schedule
| Timepoint | Box and Block Test | Secondary Measures |
|-----------|-------------------|-------------------|
| Baseline | Yes | Full battery |
| Week 4 | No | Safety check |
| Week 8 | No | Partial assessment |
| Week 12 | Yes | Full battery |
| Week 16 (Follow-up) | Yes | Partial assessment |
Eligibility Criteria
Inclusion Criteria
Exclusion Criteria
Safety Considerations
The trial includes several safety measures:
- Medical clearance required before enrollment
- Continuous vital sign monitoring during sessions
- Exercise intensity appropriate for PD patients
- Rest periods between exercises
- Emergency protocols in place
Scientific Significance
Addressing an Unmet Need
This trial addresses a critical gap in Parkinson's disease rehabilitation[@shapiro2019]:
- High prevalence: Up to 80% of PD patients experience upper limb dysfunction
- Limited evidence: Fewer rehabilitation trials focus on upper limb vs. gait/balance
- Daily impact: Upper limb impairment directly affects independence
- Undertreated: Often receives less clinical attention than other symptoms
Innovation in Rehabilitation
The phygital approach represents several innovations:
| Traditional | This Trial |
|-------------|-----------|
| Clinic-based | Can be delivered at home |
| Generic exercises | Personalized object-based training |
| Subjective progress | Objective digital tracking |
| Intrinsic motivation only | Gamified engagement |
| One-size-fits-all | Adaptive difficulty |
Comparison with Other Approaches
| Intervention | Evidence Level | Key Advantage | Limitations |
|-------------|---------------|---------------|------------|
| Conventional PT | Moderate | Established | Limited engagement |
| Exergaming (digital only) | Growing | High engagement | Lacks tactile feedback |
| Phygital (this trial) | Investigational | Combines benefits | New approach |
| Robot-assisted | Moderate | Precise control | Cost, accessibility |
| Virtual reality | Growing | Immersive | Hardware requirements |
Technical Components
Exercise System
The phygital system includes:
- Ergonomic grips for reduced tremor interference
- Variable resistance for progressive strengthening
- Different textures for sensory feedback
- Camera-based tracking system
- Position and movement accuracy
- Real-time data processing
- Multiple game modes for variety
- Adaptive difficulty based on performance
- Progress tracking and rewards
- Movement quality metrics
- Session adherence tracking
- Progress visualization
Safety Features
Designed with PD-specific considerations:
- Slowed movement detection (bradykinesia)
- Tremor accommodation
- Fatigue monitoring
- Rest periods integrated
- Emergency stop functionality
Clinical Rationale
Neuroplasticity Principles
The intervention is designed to promote neuroplasticity:
Evidence from Related Approaches
Multiple studies support exergaming in PD[@alonso2019]:
- Improved motor function (MDS-UPDRS Part III)
- Enhanced quality of life (PDQ-39)
- Better adherence vs. traditional exercises
- Improved balance and gait
- Reduced freezing of gait
The phygital approach adds:
- Tactile feedback missing from purely digital approaches
- Transfer of skills to real-world activities
- Enhanced proprioceptive input
Trial Progress and Expectations
Current Status
As of the latest update, this trial is actively recruiting at the Punjab Institute of Neuroscience in Lahore, Pakistan.
Expected Outcomes
This trial will provide:
Implications
Regardless of outcome, this trial contributes:
- Evidence for digital rehabilitation in PD
- Data on phygital approach feasibility
- Methodology for future trials
- Expansion of rehabilitation evidence to diverse populations
Limitations and Considerations
Potential Limitations
Geographic Considerations
The study in Pakistan provides important data:
- Represents understudied population
- Resource-limited setting demonstration
- Demonstrates feasibility of digital rehabilitation globally
Future Directions
This trial may inform:
- Larger multi-site trials
- Home-based delivery models
- Combination with other interventions
- Long-term maintenance protocols
- Device optimization for PD
Detailed Intervention Components
Phase 1: Warm-Up (5 minutes)
The warm-up phase prepares the upper limb for more intensive exercise:
Phase 2: Main Activity (20 minutes)
The core gaming component involves:
Game Modes:
Progressive Difficulty:
- Initial levels: Large objects, slow movements, simple patterns
- Progression: Smaller objects, faster movements, complex patterns
- Adaptation: Real-time adjustment based on performance
- Position and velocity measurement
- Accuracy and precision metrics
- Range of motion quantification
- Movement quality assessment
Phase 3: Cool-Down (5 minutes)
The cool-down phase includes:
Outcome Measure Details
Box and Block Test (BBT)
The BBT is the primary outcome measure:
Procedure:
- Two compartments divided by a partition
- 150 wooden blocks (2.5 cm per side)
- Patient transfers as many blocks as possible in 60 seconds
- Count blocks moved from one side to the other
- Number of blocks transferred (0-150)
- Higher scores indicate better dexterity
- High test-retest reliability (r = 0.95)
- Good construct validity
- Sensitive to change in PD
- Normative data available by age
9-Hole Peg Test (9HPT)
The 9-Hole Peg Test assesses fine motor coordination:
Procedure:
- Nine holes in a square pattern
- Nine pegs to be placed and removed
- Time measured from first peg placement to last peg removal
- Time in seconds (shorter is better)
- Average of two trials per hand
- Excellent reliability
- Validated in PD populations
- Sensitive to subtle deficits
Purdue Pegboard Test
Assesses fine motor skill across multiple dimensions:
Subtests:
Applications in PD:
- Detects lateralized deficits
- Tracks treatment response
- Predicts functional outcomes
MDS-UPDRS Part II
The Movement Disorder Society Unified Parkinson's Disease Rating Scale Part II assesses motor aspects of daily living:
Relevant Items:
- Handwriting
- Cutting food and handling utensils
- Dressing
- Hygiene
- Turning in bed
- 0-4 per item (0 = normal, 4 = severe impairment)
- Total score range: 0-52
- Higher scores indicate greater disability
PDQ-39
The Parkinson's Disease Questionnaire-39 assesses quality of life:
Domains:
- Mobility
- Activities of daily living
- Emotional well-being
- Stigma
- Social support
- Communication
- Bodily discomfort
- Cognition
- 0-100 scale per domain
- Lower scores indicate better quality of life
- Validated in multiple languages
Safety Monitoring Protocol
Adverse Event Monitoring
All adverse events are tracked systematically:
Categories:
- Expected (common, mild)
- Unexpected (rare or severe)
- Serious (requires hospitalization, life-threatening)
- Type and description
- Severity (mild, moderate, severe)
- Relationship to intervention (unrelated, unlikely, possible, probable, definite)
- Action taken
- Outcome
Fall Monitoring
Falls are particularly important in PD:
Definition: Unintentional coming to rest on ground, floor, or lower level
Recording:
- Number and timing of falls
- Circumstances (location, activity, environmental factors)
- Injuries sustained
- Medical attention required
- Assessment of fall risk at baseline
- Safety education
- Appropriate supervision during sessions
Vital Sign Monitoring
Safety parameters tracked during each session:
| Parameter | Normal Range | Action Threshold |
|-----------|-------------|-----------------|
| Blood pressure (systolic) | 90-140 mmHg | <90 or >160 |
| Blood pressure (diastolic) | 60-90 mmHg | <50 or >100 |
| Heart rate | 60-100 bpm | <50 or >120 |
| Respiratory rate | 12-20/min | <10 or >24 |
| Oxygen saturation | ≥95% | <92% |
Session Safety Protocols
Each session includes:
Statistical Considerations
Sample Size Justification
The sample size of 30 (15 per arm) is adequate for:
- Preliminary efficacy estimation
- Safety signal detection
- Feasibility assessment
- Effect size estimation for future trials
Analysis Plan
Primary Analysis:
- Comparison of BBT change from baseline between groups
- Mixed-model ANOVA or ANCOVA
- Intention-to-treat analysis
- Per-protocol analysis
- Subgroup analyses by disease severity, age
- Missing data sensitivity analyses
- Two-sided alpha = 0.05
- Power calculations based on effect size estimates
- Appropriate handling of multiple comparisons
Implementation Challenges and Solutions
Recruitment Challenges
Potential barriers and solutions:
| Challenge | Solution |
|-----------|----------|
| Limited awareness | Multi-channel recruitment (clinics, support groups, social media) |
| Transportation | Explore home-based delivery for future |
| Disease stage | Clear eligibility criteria, screening process |
| Competing trials | Emphasize unique features of this intervention |
Retention Strategies
To maximize completion rates:
- Flexible scheduling
- Regular communication
- Incentives for completion
- Address transportation barriers
- Maintain engagement throughout
Data Quality
Ensuring high-quality data:
- Standardized training for assessors
- Regular calibration sessions
- Centralized data management
- Quality control checks
- Audit procedures
Related Content
- [Parkinson's Disease](/diseases/parkinsons-disease)
- [Motor Symptoms in Parkinson's Disease](/mechanisms/pd-motor-symptoms)
- [Physical Therapy for Parkinson's](/therapeutics/physical-therapy-pd)
- [Digital Therapeutics for Neurodegeneration](/therapeutics/digital-therapeutics)
- [Occupational Therapy in PD](/therapeutics/occupational-therapy-pd)
References
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