VirtualPark_Pediatric
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorIstituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato
About this trial
The goal of this clinical trial is to assess the effects of a dual-task, multimodal training program on slowing functional motor decline in children and adolescents with neuromuscular disorders. The main questions it aims to answer are:
Does Virtual Park slow functional motor decline in children and adolescents with neuromuscular diseases compared with standard therapy?
Does Virtual Park contribute to increased engagement and improved neuropsychological function?
If there is a comparison group, Researchers will compare dual-task cycling supported by the Virtual Park application to standard therapy to see whether it improves motor and neuropsychological functions and engagement.
Participants will undergo two phases:
* Phase 1: 3 months of standard therapy; * Phase 2: 3 months of experimental conditions in which patients undergo a rehabilitative intervention with Virtual Park, 3 times a week.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
availability of a definitive clinical or molecular genetic diagnosis of a neuromuscular disease;
age between 6 years and 17 years and 11 months (inclusive);
height compatible with the use of the Thera-Trainer (minimum 120 cm);
performance Upper Limb Module 2.0 assessment: Entry level >= 2
Disqualifiers
other concomitant genetic diseases;
presence of visual impairments that prevent access to the experimental virtual reality protocol;
concomitant compromised cardio-respiratory function that contraindicates cycle ergometer training;
severe osteoporosis.
Trial design
Design model
Single group
Treatments tested in this trial
Dual-task cycling
DeviceVirtualPark is a software application connecting to a medical certified cycle/arm ergometer (i.e., TheraTrainer TIGO). The application allows for dual task training. In particular, while cycling, participants can perform one of four different available exercises. Each exercise is focused on a specific cognitive domain: Task 1: visual attention, inhibition and cognitive flexibility; Task 2: working memory; Task 3: inhibition; Task 4: navigation.
Standard therapy
Other interventionParticipants undergo their standard plan: outpatient treatment, if planned, or no treatment.
Treatment groups
22 Participants
are divided into 1 treatment groupGroup A: Two-phase armExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Motor Function Measure-32 (MFM-32) - Total score
The Motor Function Measure-32 is a motor skills assessment scale validated for patients affected by neuromuscular pathology from 6 years of age. The instrument consists of 32 items (scored from 0 to 3) divided into 3 dimensions: D1- standing position and transfers (13 items), D2- axial and proximal motor skills (12 items) and D3- distal motor skills (7 items). The results are expressed as a percentage in relation to the maximum score. The result of each dimension corresponds to the sum of the scores obtained by the subject in the items of this dimension divided by the maximum score of the same dimension and multiplied by 100. For the MFM-32 the total score corresponds to the sum of all the scores attributed to the subject (all dimensions together) divided by 96 and multiplied by 100.
Time frame
Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)Secondary outcomes
1
North Star Ambulatory Assessment (NSSA)
\[FOR AMBULATORY PARTICIPANTS ONLY\] The North Star Ambulatory Assessment (NSSA) scale was developed specifically for ambulatory children with dystrophinopathy starting at age 5 to obtain information on their motor and functional abilities. The instrument consists of 17 items scored from 0 to 2. The final score is the sum of the scores obtained for all items. Two timed tests are also recorded: the time to stand up from the ground and the time required to walk/run 10 meters.
Time frame
Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)2
Timed functional tests (TFTs)
\[FOR AMBULATORY PARTICIPANTS ONLY\] Timed functional tests (TFTs) are administered in a standardized manner to subjects with Duchenne muscular dystrophy to measure the time taken to perform the following four activities: moving from a supine to a standing position, walking/running for 10 meters, and ascending and descending a standardized 4-step staircase. The scoresheet records, in addition to the time taken to complete the task, a qualitative grading score from 1 to 6.
Time frame
Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)3
6-Minute Walking Test (6MWT)
\[FOR AMBULATORY PARTICIPANTS ONLY\] The 6-Minute Walking Test (6MWT) was developed in the cardio-respiratory field but is now used across various fields of motor rehabilitation where it is necessary to quantify the patient's walking endurance. The test measures the distance a patient can cover, walking on a flat surface along a standardized path, in a period of 6 minutes \[25\]. In addition to the total distance covered, the distances covered for each minute are also collected and any falls/pauses are recorded.
Time frame
Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)4
Performance Upper Limb Module 2.0 scale (PUL version 2.0)
\[FOR NON-AMBULATORY PARTICIPANTS ONLY\] The Performance Upper Limb Module 2.0 scale (PUL version 2.0) was developed to evaluate the motor performance of the upper limbs of subjects with dystrophinopathies from 5 years of age. This latest version of the instrument consists of an entry item useful for defining the patient's functional level and scored separately (from 0 to 6) and of 22 other items (scored from 0 to 2). The final score is made up of 2 values: the entry level score and the total score given by the sum of the scores obtained in the individual items \[26\].
Time frame
Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)Other outcomes
1
NEPSY-II
The NEPSY-II scale is a battery of tests that allows a neuropsychological evaluation of pediatric subjects, in relation to specific cognitive domains. It is composed of 33 tests that refer to 6 different cognitive domains (Attention and Executive Functions, Language, Memory and Learning, Sensorimotor Functions, Social Perception, Visuospatial Processing). For the purposes of the study, the items "list memory" and "drawing memory" (Memory and Learning domain), the item "Inhibition" (Attention and Executive Functions domain) and the item "find the way" (Visuospatial Processing domain) are used.
Time frame
Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)2
Endurance
Measurement of heart rate (HR) and heart rate variability (HRV) collected with a wearable sensor (chest band), Movesense Medical (class IIa MDR 2017/745) or comparable medically certified device.
Time frame
Continuously assessed during each training session from Month 3 (T1) to Month 6 (T2).3
User Engagement Scale-Short Form (UES-SF)
The User Engagement Scale-Short Form (UES-SF) questionnaire will be used to measure engagement. It is a self-report questionnaire, composed of 12 items rated on a 5-point Likert scale (1 = strongly disagree; 5 = strongly agree). In particular, the UES-SF questionnaire investigates the following four factors: perceived usability, aesthetic appeal, focused attention, and reward. This questionnaire will be administered to the study participants in the Italian version, for which the scale has been translated and validated.
Time frame
Every week (i.e., every 3 sessions) from Month 3 (T1) to Month 6 (T2).4
Device safety
The number and description of any adverse events attributable to the use of the device are collected. Adverse events are monitored in accordance with MDR 2017/745, with events reported to responsible office of the Ministry of Health and the relevant Ethical Committee.
Time frame
From Month 3 (T1) to Month 6 (T2).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato
Lead sponsor
IRCCS National Neurological Institute "C. Mondino" Foundation
Collaborator
IRCCS Eugenio Medea
Collaborator
Fondazione Don Carlo Gnocchi ETS
Collaborator
IRCCS Fondazione Stella Maris
Collaborator
Source ClinicalTrials.gov