Clinical Trial Identifier: NCT07475741
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.
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.
| 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
Upper limb impairment in Parkinson's disease presents as:
- Bradykinesia: Slowness of movement affecting reaching, grasping, and manipulation
- Rigidity: Increased muscle tone limiting range of motion
- Fine motor deficits: Impaired precision grip anddexterity
- Impaired coordination: Difficulty with sequential movements
- Reduced velocity: Slower movement speeds during functional tasks
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
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
Exergaming (exercise + gaming) combines physical activity with game-based motivation, offering several advantages:
- 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
This trial introduces a "phygital" approach combining physical objects with digital game-based rehabilitation:
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
Digital Integration:
- Motion tracking sensors capture movement data
- Games respond to physical object manipulation
- Progress tracking and scoring
- Remote monitoring capability
Synergy:
- 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
This is a randomized controlled trial comparing phygital exergaming with conventional physical therapy.
| 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 |
The phygital exergaming intervention uses specialized software with physical objects:
Physical Objects Used:
- Grasping objects: Variably sized blocks for grip training
- Manipulation objects: Balls of different sizes and textures
- Reach objects: Cushions and targets for arm movement
- Resistance objects: Weighted objects for strengthening
Game Components:
- Virtual environments that respond to physical object manipulation
- Progressive difficulty levels
- Score tracking and achievement systems
- Movement quality feedback
Session Structure:
- Warm-up (5 minutes): Gentle range of motion exercises
- Main activity (20 minutes): Game-based object manipulation
- Cool-down (5 minutes): Stretching and relaxation
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
-
Box and Block Test (BBT)
- 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
-
9-Hole Peg Test (9HPT)
- Measures fine motor coordination
- Time to place and remove 9 pegs
- Sensitive to PD upper limb impairment
- Assessment timepoints: Baseline and 12 weeks
-
Motor Function
- MDS-UPDRS Part III: Motor examination (bradykinesia subscore)
- Purdue Pegboard Test: Assesses fine motor skill
- Jamar Dynamometer: Grip strength measurement
-
Functional Independence
- Barthel Index: Activities of daily living
- MDS-UPDRS Part II: Motor aspects of daily living
-
Quality of Life
- PDQ-39: Parkinson's Disease Questionnaire-39
- SF-36: Short Form Health Survey
-
Safety Measures
- Adverse events monitoring
- Fall incidence
- Exercise tolerance
| 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 |
- Diagnosis: Early-stage Parkinson's disease (Hoehn & Yahr stages I-III)
- Age: 45-85 years
- Cognition: MMSE score ≥ 24 (no significant cognitive impairment)
- Communication: Able to communicate and understand commands
- Medication: On regular Levodopa/carbidopa medication (stable dose ≥ 4 weeks)
- Upper limb involvement: Clinically evident upper limb motor impairment
- Consent: Willing to provide informed consent and attend all sessions
- Disease stage: Advanced stage IV-V Parkinson's disease (Hoehn & Yahr)
- Cognition: Severe cognitive deficits (MMSE < 24)
- Neurological history: History of neurological or musculoskeletal conditions affecting hand use (stroke, arthritis, neuropathy)
- Medical stability: Not taking medicine for systemic illness
- Surgical history: Upper limb orthopedic surgery within past 6 months
- Visual impairment: Severe visual impairment preventing participation
- Other exclusion: Any other condition that, in investigator's judgment, precludes participation
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
This trial addresses a critical gap in Parkinson's disease rehabilitation:
- 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
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 |
| 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 |
The phygital system includes:
-
Physical Objects: Specially designed objects for PD patients
- Ergonomic grips for reduced tremor interference
- Variable resistance for progressive strengthening
- Different textures for sensory feedback
-
Motion Capture: Technology to track object movement
- Camera-based tracking system
- Position and movement accuracy
- Real-time data processing
-
Game Software: Engaging rehabilitation games
- Multiple game modes for variety
- Adaptive difficulty based on performance
- Progress tracking and rewards
-
Data Dashboard: For clinicians and researchers
- Movement quality metrics
- Session adherence tracking
- Progress visualization
Designed with PD-specific considerations:
- Slowed movement detection (bradykinesia)
- Tremor accommodation
- Fatigue monitoring
- Rest periods integrated
- Emergency stop functionality
The intervention is designed to promote neuroplasticity:
- Repetitive practice: High number of repetitions (game-based)
- Task-specific training: Real-world object manipulation
- Implicit learning: Games promote motor learning without explicit focus
- Reward engagement: Dopaminergic activation from game rewards may enhance learning
- Attention: Increased attention from game engagement enhances encoding
Multiple studies support exergaming in PD:
- 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
As of the latest update, this trial is actively recruiting at the Punjab Institute of Neuroscience in Lahore, Pakistan.
This trial will provide:
- Efficacy data: Does phygital exergaming improve upper limb function?
- Comparison: How does it compare to conventional PT?
- Safety: Is the approach safe in PD patients?
- Feasibility: Can this be implemented in resource-limited settings?
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
- Sample size: 30 participants may limit generalizability
- Single site: Results may not generalize to other populations
- Duration: 12-week follow-up may miss long-term effects
- Blinding: Therapist and patient unblinded may introduce bias
- Disease stage: Only early-stage patients included
The study in Pakistan provides important data:
- Represents understudied population
- Resource-limited setting demonstration
- Demonstrates feasibility of digital rehabilitation globally
This trial may inform:
- Larger multi-site trials
- Home-based delivery models
- Combination with other interventions
- Long-term maintenance protocols
- Device optimization for PD
The warm-up phase prepares the upper limb for more intensive exercise:
- Passive range of motion: Therapist-assisted movement through comfortable ranges
- Active range of motion: Patient-initiated movement without resistance
- Dynamic stretching: Gentle arm circles, wrist flexion/extension
- Task-oriented热身: Simple reaching movements toward targets
¶ Phase 2: Main Activity (20 minutes)
The core gaming component involves:
Game Modes:
- Block stacking: Virtual blocks that respond to physical block manipulation
- Target reaching: Hitting targets at various positions to train range of motion
- Ball manipulation: Catching and throwing virtual balls with physical balls
- Pattern tracing: Following visual paths with physical objects
- Collection games: Gathering items by manipulating objects
Progressive Difficulty:
- Initial levels: Large objects, slow movements, simple patterns
- Progression: Smaller objects, faster movements, complex patterns
- Adaptation: Real-time adjustment based on performance
Movement Tracking:
- Position and velocity measurement
- Accuracy and precision metrics
- Range of motion quantification
- Movement quality assessment
The cool-down phase includes:
- Gentle stretching: Upper limb muscle groups
- Relaxation techniques: Breathing and progressive relaxation
- Functional practice: Simulated ADL tasks
- Progress review: Summary of session performance
¶ 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
Scoring:
- Number of blocks transferred (0-150)
- Higher scores indicate better dexterity
Psychometric Properties:
- High test-retest reliability (r = 0.95)
- Good construct validity
- Sensitive to change in PD
- Normative data available by age
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
Scoring:
- Time in seconds (shorter is better)
- Average of two trials per hand
Properties:
- Excellent reliability
- Validated in PD populations
- Sensitive to subtle deficits
Assesses fine motor skill across multiple dimensions:
Subtests:
- Right hand: Insert as many pins as possible in 30 seconds
- Left hand: Same for left hand
- Both hands: Alternating hands to insert pins
- Assembly: Assemble pins, washers, and collars
Applications in PD:
- Detects lateralized deficits
- Tracks treatment response
- Predicts functional outcomes
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
Scoring:
- 0-4 per item (0 = normal, 4 = severe impairment)
- Total score range: 0-52
- Higher scores indicate greater disability
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
Scoring:
- 0-100 scale per domain
- Lower scores indicate better quality of life
- Validated in multiple languages
All adverse events are tracked systematically:
Categories:
- Expected (common, mild)
- Unexpected (rare or severe)
- Serious (requires hospitalization, life-threatening)
Recording:
- Type and description
- Severity (mild, moderate, severe)
- Relationship to intervention (unrelated, unlikely, possible, probable, definite)
- Action taken
- Outcome
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
Prevention measures:
- Assessment of fall risk at baseline
- Safety education
- Appropriate supervision during sessions
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% |
Each session includes:
- Pre-session check: Verify patient readiness, medication status
- During session: Continuous observation, rest breaks available
- Post-session: Review of any concerns, advise on post-session activity
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
Primary Analysis:
- Comparison of BBT change from baseline between groups
- Mixed-model ANOVA or ANCOVA
- Intention-to-treat analysis
Secondary Analyses:
- Per-protocol analysis
- Subgroup analyses by disease severity, age
- Missing data sensitivity analyses
Statistical Considerations:
- Two-sided alpha = 0.05
- Power calculations based on effect size estimates
- Appropriate handling of multiple comparisons
¶ Implementation Challenges and Solutions
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 |
To maximize completion rates:
- Flexible scheduling
- Regular communication
- Incentives for completion
- Address transportation barriers
- Maintain engagement throughout
Ensuring high-quality data:
- Standardized training for assessors
- Regular calibration sessions
- Centralized data management
- Quality control checks
- Audit procedures