NCT06738290

Brief Summary

Manual dexterity deficits and loss of motor automaticity are commonly seen in patients with Parkinson's disease (PD). Amongst these problems, using a touchscreen is becoming increasingly burdensome. In addition, a variety of non-motor symptoms, including cognitive impairment have a significant impact on the quality of life of patients with PD which will also affect the use of mobile devices. As the degradation of dopaminergic neurons in the striatum results in an impaired capacity for motor learning and more specifically for consolidation in motor memory, the investigators want to unravel the remaining rehabilitation potential in this patient group. Recent work on the consolidation of an intensive writing training program from our group, indicated inconsistent and variable results on retention of learning gains, which strongly depended on the clinical profile of the patients involved. This raises the question whether it is possible to predict different training responses and better understand how this is determined by clinical characteristics, such as disease severity and the degree of cognitive impairment. Also, baseline task performance and early acquisition may determine long-term learning outcomes. Our main focus (primary dependent outcome) is to know which patients will be able to retain the learning gains after 4 weeks without training. For this aim, the investigators will use a home-based training program of a touchscreen task called the Swipe-Slide Pattern (SSP) task. Training of this SSP-task will be offered on a tablet under single and dual task conditions in a random fashion, not only to provide variation but also to increase the cognitive challenge, thereby stimulating consolidation. A crucial factor, which may affect the success of training, is compliance, which the investigators will measure objectively for the first time. As independent variables the investigators will measure several motor and cognitive functions as well as compliance, while including a broad sample of PD patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 10, 2022

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 17, 2024

Completed
Last Updated

March 3, 2025

Status Verified

December 1, 2024

Enrollment Period

2.9 years

First QC Date

December 12, 2024

Last Update Submit

February 27, 2025

Conditions

Keywords

Neurologic rehabilitationMotor learningTouchscreen skillsPersonalization

Outcome Measures

Primary Outcomes (1)

  • Overall learning effects of training on the average slide duration in ST condition

    Using the behavioral data gathered at the different time points (described in Time frame), the changes in average slide duration in ST condition will be determined and used in a multiple linear regression model as dependent variable.

    Baseline and retention (4 weeks)

Secondary Outcomes (6)

  • Immediate training effects and retention of training on performance accuracy in ST condition

    Baseline, post (2 weeks) and retention (4 weeks)

  • Immediate training effects and retention of training of the average slide duration in ST condition

    Baseline, post (2 weeks) and retention (4 weeks)

  • Immediate and retained training effects and overall learning of the average slide duration in DT condition

    Baseline, post (2 weeks) and retention (4 weeks)

  • Immediate and retained training effects and overall learning on performance accuracy in DT condition

    Baseline, post (2 weeks) and retention (4 weeks)

  • Transfer of learning towards an untrained Mobile Phone Task

    Baseline, post (2 weeks) and retention (4 weeks)

  • +1 more secondary outcomes

Study Arms (1)

Parkinson's disease

Only one cohort will be observed. All participants have been diagnosed with Parkinson's disease, according to the criteria of the Movement Disorders Society by a movement disorders specialist. Other eligibility criteria are described below.

Behavioral: Targeted home-based touchscreen training

Interventions

Participants will practice the Swipe-Slide Pattern (SSP) task independently at home in both ST and DT condition, offered in a random order. During this task, participants perform different pre-defined patterns by moving their finger over a touchscreen, resembling a touchscreen unlock trace. The DT condition includes the SSP-task while counting either red or green lights illuminated on the screen. They will receive 10 training sessions of the SSP-task over a period of two weeks. Each week will consist of 5 consecutive days of training for approximately 10 min. per session. Participants will perform 9 trials of 12 patterns each, alternated with rest periods of 14s. Instruction and answers are also included. Feedback will be provided during the rest periods.

Parkinson's disease

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Recruiting of PD patients will be in collaboration with Prof. Dr. Wim Vandenberghe and Dr. Bruno Bergmans. Patients will receive information about the study after which they can contact the researcher. In addition, our lab has a database with contact information of patients that allowed storages of their information. Moreover, our network of neurologists and physiotherapists across Flanders will be contacted. Finally, our website contains all the information about the ongoing studies. All interested patients will receive detailed information about the aims and procedures of the study before partaking in the study.

You may qualify if:

  • Diagnosis of idiopathic Parkinson's disease based on the criteria of the Movement Disorders Society
  • Right-handed, or right-handed use of touchscreen devices.

You may not qualify if:

  • Parkinson's disease dementia (PD-D), determined by the level I diagnostics according to Dubois et al. (2007)
  • Comorbidities of the upper limb that could interfere with the study and are not caused by Parkinson's disease
  • Other neurological disorders besides Parkinson's disease
  • Color blindness as determined by the Ishihara test for color deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rehabilitation Sciences KU Leuven

Leuven, 3001, Belgium

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Alice Nieuwboer, PhD

    KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Emeritus Professor

Study Record Dates

First Submitted

December 12, 2024

First Posted

December 17, 2024

Study Start

January 10, 2022

Primary Completion

December 12, 2024

Study Completion

December 13, 2024

Last Updated

March 3, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations