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Parkinson DiseaseNCT05696197

Learning Potential of Patients With Parkinson's Disease After Two Weeks of Targeted Touchscreen Training

A study testing Targeted touchscreen training in people with Parkinson Disease, run by KU Leuven at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Parkinson's disease (PD) is characterized by severe motor and non-motor symptoms, including upper limb dysfunction. Due to the degradation of dopaminergic neurons in the striatum, PD patients experience difficulties with motor learning and more specifically with the consolidation of motor memory. Read more about this study

Who is it for?
Any age
Conditions the study is for
Parkinson Disease
What is being tested?
Targeted touchscreen training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteBelgium
Study dates
10 Jan 2022to 31 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Diagnosis of Parkinson's disease based on the 'UK Brain Bank' criteria
  • Hoehn and Yahr (H\&Y) stage I-III, participants in H\&Y stage I should have the right side as the most affected side
  • Right handed, or right-handed use of touchscreen devices.

Who cannot join

  • Cognitive decline (Mini Mental State Examination < 24)
  • 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

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • Department of Rehabilitation Sciences KU Leuven

    Leuven, 3000

Other trials in Belgium

About this study

Official title: Predicting Motor Learning of an Upper Limb Task Based on Behavioral and Disease-specific Characteristics in Patients With Parkinson's Disease

Parkinson's disease (PD) is characterized by severe motor and non-motor symptoms, including upper limb dysfunction. Due to the degradation of dopaminergic neurons in the striatum, PD patients experience difficulties with motor learning and more specifically with the consolidation of motor memory. Recent work showed that intensive writing training improved writing skills in PD. Although consolidation effects were present, difficulties with retention were also still apparent. Besides impacting writing, manual dexterity deficits in PD can also affect the use of touchscreens. Researchers from our lab demonstrated that impairments were most pronounced in multi-direction sliding motions, indicating the need for training of these motor skills. Our lab demonstrated the classic difficulties with retention in PD after one session of training of a swipe and slide pattern on a tablet (SSP-task) as single task (ST), although immediate gains were demonstrated. Therefore, in this study the investigators will examine whether a two-week home-based training program of a tablet-based SSP-training program will lead to immediate and consolidated improvements that are retained in time. This program will combine ST and dual task (DT) training to provide variation during the training period, but also to increase the cognitive challenge during learning, thereby stimulation consolidation of learning. The primary aim of this study consists of investigating the learning effects after two weeks of targeted touchscreen training. Secondary, the investigators will examine whether these effects will also be retained after four weeks without practice and whether targeted training results in consolidated improvements, in terms of automaticity and transfer towards an untrained task. Given the objective recording of compliance to the training protocol, the investigators will explore the association between compliance rates and learning effects.

Read the detailed description

Given the impaired touchscreen skills and the espoused difficulties with retention in PD, th e investigators will examine the training of touchscreen sliding motions delivered on a tablet enabling practice in the home setting. Both ST and DT conditions will be offered in a random order and feedback will be provided by means of knowledge of performance to enhance motivation and retention, as proved successful in previous work. The objective of this study is to examine the effects of this innovative training program immediately after two weeks of targeted training as the primary outcome in a randomized controlled trial (RCT). To resemble daily life as much as possible, all test and training sessions will be carried out in the ON-phase of the medication-cycle, i.e., approximately 1 hour after last medication intake. The effect of a 2-week home-based training program with a 4-week follow-up will be examined by including 36 PD patients, who will be randomized (strata: age, H\&Y stage) in the experimental or control group. Sample size was based on the pilot study using the SSP-task showing an average movement time of 7.4s ± 3.43 in PD for sequence swiping at baseline in ST. Based on literature, the researchers assumed an improvement of 20.2% following training at retention. For the control group, the researchers expect a deterioration in performance of 5.6% after a period without training based on the changes observed in the control groups of recent studies investigating manual dexterity parameters over time. Using an α = 0.05 and β = 0.20, a sample size was calculated for repeated measures ANOVA analysis with a within-between factor interaction design (within: pre - post - retention; between: experimental group - control group). Consequently, total sample size was estimated at 30 participants. Taking a 20% dropout rate into account, this resulted in a total of 18 participants in each group.

The experimental group will train the SSP task for a duration of two weeks, whereas the control group will not receive any intervention. On day 1 (T0), all participants will undergo an extensive screening session, including motor and non-motor screening. Testing can be performed at the subject's home or in our laboratory according to patients' preference.

The average slide duration (in ms) and the accuracy (as the number of correctly formed patterns in %) on the SSP-task will be recorded as the main digitised outcomes, objectively recorded via the tablet. In addition to evaluating the immediate effects of touchscreen training, the investigators will also test retention effects after four weeks without training as a secondary outcome. Further, consolidation of learning will be assessed using secondary outcomes such as the SSP-test in ST and DT conditions to assess automaticity of learning, the mobile phone task to test transfer of learning (MPT, typing a predefined telephone number on a smartphone). As tertiary outcomes, specific questionnaires to capture motor and cognitive performance will be administered. Following the baseline session, the experimental group will receive 10 training sessions of the SSP-training (5 days/week, 10 min/session) over a period of two weeks. The training is home-based and unsupervised but is extensively explained by an expert trainer. The control group does not receive training. Both immediately after training (T1) and after a four-week retention period (T2), touchscreen motor skills will be re-assessed at home. The most appropriate linear mixed models will be used to analyse SSP performance, with group (intervention - control) as between-subject factor and time (baseline - post - retention) as within-subject factor. LEDD and other confounders will be included as covariates.

PD is a highly heterogeneous disorders, not only affecting motor but also cognitive functions. In fact, up to 80% of patients develops dementia over the disease course. Previous studies have identified global cognitive function as important determinants of training success. Therefore, cognitive function will be assessed extensively during the baseline session to investigate the association with training responsiveness. A global cognitive screen will consist of the Montreal Cognitive Assessment. Moreover, 2 specific tests will be used to assess each cognitive subdomain. Attention and working memory will be assessed using a digit and visual span forward and backward. The trail making test and alternating names test will be used for executive function. Visuospatial function will be examined using the short form of the Benton's judgement of line orientation and the Rey Osterrieth Complex figure. The 30-min recall of the latter test will also be used to assess memory, together with the Rey Auditory Verbal Learning test. The Boston naming test and the Animal fluency test of the Controlled Oral Word Association test will be used to assess language. Other non-motor features, such as anxiety, depression, and sleep quality, will be tested using validated questionnaires for PD.

Another important determinant of rehabilitation success is training compliance. However, previous studies have used self-reported logbooks of home-based exercise, which show high inter-participant variability. As such, our training program overcomes this limitation as training compliance is automatically recorded via the digitized training tablet. The investigators will explore whether compliance to training has an impact on learning effects within the training group by using a correlation analysis between compliance rates and training-related changes in performance.

Being tested
Targeted touchscreen training
Keywords
Neurological rehabilitation, Motor learning, Touchscreen skills, Home-based training
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Targeted touchscreen trainingBehavioural

    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 form 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 minutes per session. Participants will perform 9 trials of 12 patterns each, alternated with rest periods of 14 seconds. Instruction and answers are also included. Feedback will be provided by means of knowledge of performance. On each training day, participants will receive a reminder on the training tablet.

Study groups in NCT05696197
Study groupRoleWhat they receive
Experimental groupExperimentalPracticing the Swipe Slide Pattern task in ST and DT conditions, offered in a random order over a period of 2 weeks, 5 days a week, approximately 10 minutes per training session. Training will be performed independently at home.
Receives: Behavioral: Targeted touchscreen training
Control groupNo interventionParticipants in the control group will receive no intervention during the study period. They are given the opportunity to perform the SSP-training after the study period to ensure motivation in this group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average slide duration (in ms) after two weeks of training

    The automatically recorded slide duration will be averaged and compared between the experimental group and the control group.

    Measured: Baseline and post-training (2 weeks)

Secondary outcomes (3)
  1. Performance accuracy (in %)

    The performance accuracy will be calculated as the number of correctly performed patterns and will be compared between the experimental group and the control group.

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

  2. Retention effects on average slide duration (in ms) after four weeks follow-up

    The automatically recorded slide duration will be averaged and compared between the experimental group and the control group.

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

  3. Consolidation effects of two weeks of training

    Using the behavioral data gathered at the different time points described in Time frame, dual task interference will be calculated and compared between groups (experimental vs control), moreover the transfer towards an untrained task will be examined and compared between groups. The untrained task contains the mobile phone task, in which the time necessary to type in a predefined telephone number is recorded (in s).

    Measured: Baseline, post-training (2 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2023
  2. Study start10 Jan 2022
  3. Primary completion19 Jan 2023
  4. Study completion31 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel, randomization in two groups (intervention/control)
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05696197
Sponsor's protocol ID
S64842
Status last verified
Dec 2024
First submitted
13 Jan 2023
Last updated
23 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Nackaerts E, Heremans E, Vervoort G, Smits-Engelsman BC, Swinnen SP, Vandenberghe W, Bergmans B, Nieuwboer A. Relearning of Writing Skills in Parkinson's Disease After Intensive Amplitude Training. Mov Disord. 2016 Aug;31(8):1209-16. doi: 10.1002/mds.26565. Epub 2016 Mar 17.

    PubMed 26990651
  • Nieuwboer A, Rochester L, Muncks L, Swinnen SP. Motor learning in Parkinson's disease: limitations and potential for rehabilitation. Parkinsonism Relat Disord. 2009 Dec;15 Suppl 3:S53-8. doi: 10.1016/S1353-8020(09)70781-3.

    PubMed 20083008
  • Nackaerts E, Ginis P, Heremans E, Swinnen SP, Vandenberghe W, Nieuwboer A. Retention of touchscreen skills is compromised in Parkinson's disease. Behav Brain Res. 2020 Jan 27;378:112265. doi: 10.1016/j.bbr.2019.112265. Epub 2019 Sep 27.

    PubMed 31568836
  • Sidaway B, Ala B, Baughman K, Glidden J, Cowie S, Peabody A, Roundy D, Spaulding J, Stephens R, Wright DL. Contextual Interference Can Facilitate Motor Learning in Older Adults and in Individuals With Parkinson's Disease. J Mot Behav. 2016 Nov-Dec;48(6):509-518. doi: 10.1080/00222895.2016.1152221. Epub 2016 Jun 24.

    PubMed 27340809
  • Taghizadeh G, Azad A, Kashefi S, Fallah S, Daneshjoo F. The effect of sensory-motor training on hand and upper extremity sensory and motor function in patients with idiopathic Parkinson disease. J Hand Ther. 2018 Oct-Dec;31(4):486-493. doi: 10.1016/j.jht.2017.08.001. Epub 2017 Nov 14.

    PubMed 29150384
  • Correa TV, da Silva Rocha Paz T, Allodi S, de Britto VLS, Correa CL. Progressive muscle-strength protocol for the functionality of upper limbs and quality of life in individuals with Parkinson's disease: Pilot study. Complement Ther Med. 2020 Aug;52:102432. doi: 10.1016/j.ctim.2020.102432. Epub 2020 May 23.

    PubMed 32951706
  • Aarsland D, Andersen K, Larsen JP, Lolk A, Kragh-Sorensen P. Prevalence and characteristics of dementia in Parkinson disease: an 8-year prospective study. Arch Neurol. 2003 Mar;60(3):387-92. doi: 10.1001/archneur.60.3.387.

    PubMed 12633150
  • Lofgren N, Conradsson D, Joseph C, Leavy B, Hagstromer M, Franzen E. Factors Associated With Responsiveness to Gait and Balance Training in People With Parkinson Disease. J Neurol Phys Ther. 2019 Jan;43(1):42-49. doi: 10.1097/NPT.0000000000000246.

    PubMed 30531385
  • Strouwen C, Molenaar EALM, Munks L, Broeder S, Ginis P, Bloem BR, Nieuwboer A, Heremans E. Determinants of Dual-Task Training Effect Size in Parkinson Disease: Who Will Benefit Most? J Neurol Phys Ther. 2019 Jan;43(1):3-11. doi: 10.1097/NPT.0000000000000247.

    PubMed 30531381
  • Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.

    PubMed 15817019
  • BLACKBURN HL, BENTON AL. Revised administration and scoring of the digit span test. J Consult Psychol. 1957 Apr;21(2):139-43. doi: 10.1037/h0047235. No abstract available.

    PubMed 13416432
  • Llinas-Regla J, Vilalta-Franch J, Lopez-Pousa S, Calvo-Perxas L, Torrents Rodas D, Garre-Olmo J. The Trail Making Test. Assessment. 2017 Mar;24(2):183-196. doi: 10.1177/1073191115602552. Epub 2016 Jul 28.

    PubMed 26318386
  • Hyde T, Fritsch T. Assessing executive function in Parkinson disease: the alternating names test. Part I. Reliability, validity, and normative data. Parkinsonism Relat Disord. 2011 Feb;17(2):100-5. doi: 10.1016/j.parkreldis.2010.08.023. Epub 2010 Nov 30.

    PubMed 21123105
  • Winegarden BJ, Yates BL, Moses JA, Benton AL, Faustman WO. Development of an optimally reliable short form for Judgment of Line Orientation. Clin Neuropsychol. 1998;12(3):311-314. doi:10.1076/clin.12.3.311.1992

  • Gullett JM, Price CC, Nguyen P, Okun MS, Bauer RM, Bowers D. Reliability of three Benton Judgment of Line Orientation short forms in idiopathic Parkinson's disease. Clin Neuropsychol. 2013;27(7):1167-78. doi: 10.1080/13854046.2013.827744. Epub 2013 Aug 19.

    PubMed 23957375

Questions about this trial

What is this clinical trial studying?

A study testing Targeted touchscreen training in people with Parkinson Disease, run by KU Leuven at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average slide duration (in ms) after two weeks of training (time frame: Baseline and post-training (2 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05696197, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.

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