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

Sponsor

KU Leuven (Other)

Overall Status

Recruiting

CT.gov ID

NCT05696197

Collaborator

(none)

Enrollment

Location

Arms

13.6

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Behavioral: Targeted touchscreen training	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel, randomization in two groups (intervention/control)Parallel, randomization in two groups (intervention/control)

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 10, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group 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.	Behavioral: Targeted touchscreen training 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.
No Intervention: Control group 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.

Arm

Intervention/Treatment

Experimental: Experimental group

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.

Behavioral: Targeted touchscreen training

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.

No Intervention: Control group

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.

Outcome Measures

Primary Outcome Measures

Average slide duration (in ms) after two weeks of training [Baseline and post-training (2 weeks)]
The automatically recorded slide duration will be averaged and compared between the experimental group and the control group.

Secondary Outcome Measures

Performance accuracy (in %) [Baseline, post (2 weeks) and retention (4 weeks)]
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.
Retention effects on average slide duration (in ms) after four weeks follow-up [Baseline, post (2 weeks) and retention (4 weeks)]
The automatically recorded slide duration will be averaged and compared between the experimental group and the control group.
Consolidation effects of two weeks of training [Baseline, post-training (2 weeks)]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Rehabilitation Sciences KU Leuven	Leuven		Belgium	3000

Sponsors and Collaborators

KU Leuven

Investigators

Principal Investigator: Alice Nieuwboer, PhD, KU Leuven

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Alice Nieuwboer, Full Professor, KU Leuven

ClinicalTrials.gov Identifier:

NCT05696197

Other Study ID Numbers:

S64842

First Posted:

Jan 25, 2023

Last Update Posted:

Jan 25, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Alice Nieuwboer, Full Professor, KU Leuven

Neurological rehabilitation

Motor learning

Touchscreen skills

Home-based training

Additional relevant MeSH terms:

Parkinson Disease

Study Results

No Results Posted as of Jan 25, 2023