NCT07475741

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress45%
Feb 2026Nov 2026

Study Start

First participant enrolled

February 20, 2026

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

March 5, 2026

Last Update Submit

May 14, 2026

Conditions

Keywords

ExergamingParkinson DiseasePhysical TherapyUpper Limb Rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Box and Block Test

    The Box and Block Test (BBT) is a 60-second, standardized, unilateral assessment measuring gross manual dexterity in individuals with Parkinson's Condition

    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.

Study Arms (2)

Control Group (Conventional Physical Therapy Group)

ACTIVE COMPARATOR

It will act as control group. The participants in this control group will receive the 36 sessions (three sessions per week over 12 weeks), each lasting approximately 30 minutes).

Procedure: Conventional Physical Therapy

Phygital Group (Exergamig)

EXPERIMENTAL

The intervention group (phygital) will receive thirty six 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.

Combination Product: Exergaming

Interventions

ExergamingCOMBINATION_PRODUCT

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.

Also known as: Phygital Training
Phygital Group (Exergamig)

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

Also known as: Strength Training, Flexibility and Mobility, Balance and Coordination, Gait and Functional Training, Conentional Physical Therapy
Control Group (Conventional Physical Therapy Group)

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Punjab institute of Neuroscience Lahore

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

ExergamingResistance TrainingPliabilityRange of Motion, ArticularGait

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanMechanical PhenomenaPhysical PhenomenaPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisWalkingLocomotion

Study Officials

  • Dr. Nadia Naseem, Ph.D.

    University of Health Sciences Lahore

    STUDY CHAIR

Central Study Contacts

Hafiz Muddassir Riaz, Ph.D Scholar

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

March 5, 2026

First Posted

March 16, 2026

Study Start

February 20, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

May 19, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations