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.
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
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- 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.
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.
- Conditions
- Parkinson Disease
- 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 group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Practicing 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 group | No intervention | Participants 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.
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)
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)
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)
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.
- First posted25 Jan 2023
- Study start10 Jan 2022
- Primary completion19 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alice Nieuwboer, KU Leuven
- Investigators
- Alice Nieuwboer, PhD, Principal investigator, KU Leuven
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 26990651Nieuwboer 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 20083008Nackaerts 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 31568836Sidaway 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 27340809Taghizadeh 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 29150384Correa 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 32951706Aarsland 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 12633150Lofgren 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 30531385Strouwen 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 30531381Nasreddine 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 15817019BLACKBURN 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 13416432Llinas-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 26318386Hyde 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 21123105Winegarden 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Motor Learning of an Upper Limb Task Based on Behavioral and Disease-specific Characteristics in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05696197
- Acronym / sponsor ID
- S64842
- Conditions
- Parkinson Disease
- Keywords
- Neurological rehabilitation, Motor learning, Touchscreen skills, Home-based training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 19 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel, randomization in two groups (intervention/control)
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Targeted touchscreen trainingPracticing 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. |
| Control group | No intervention | –Participants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted touchscreen trainingParticipants 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. | Behavioural | Experimental group |
Primary outcome
Average slide duration (in ms) after two weeks of training
Time frame: Baseline and post-training (2 weeks)
The automatically recorded slide duration will be averaged and compared between the experimental group and the control group.
3 secondary outcomes
Performance accuracy (in %)
Time frame: Baseline, post (2 weeks) and retention (4 weeks)
Retention effects on average slide duration (in ms) after four weeks follow-up
Time frame: Baseline, post (2 weeks) and retention (4 weeks)
Consolidation effects of two weeks of training
Time frame: Baseline, post-training (2 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Background: PubMed 26990651Nackaerts 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.
- Background: PubMed 20083008Nieuwboer 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.
- Background: PubMed 31568836Nackaerts 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.
- Background: PubMed 27340809Sidaway 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.
- Background: PubMed 29150384Taghizadeh 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.
- Background: PubMed 32951706Correa 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.
- Background: PubMed 12633150Aarsland 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.
- Background: PubMed 30531385Lofgren 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.
- Background: PubMed 30531381Strouwen 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.
- Background: PubMed 15817019Nasreddine 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.
- Background: PubMed 13416432BLACKBURN 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.
- Background: PubMed 26318386Llinas-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alice Nieuwboer, PhD principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
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.