DystrophinopathyNCT07580365
VirtualPark_Pediatric
A study testing Dual-task cycling and Standard therapy in people with Dystrophinopathy and Muscular Dystrophies, run by Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato at 4 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Dystrophinopathy, Muscular Dystrophies, Congenital Myopathies
- What is being tested?
- Dual-task cycling and Standard therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 4 sitesItaly
- Study dates
- 30 Jun 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy4 sites, 3 recruiting
- Recruiting
IRCCS E. Medea - La Nostra Famiglia
Bosisio Parini, LC, 23849
Emilia Biffi, emilia.biffi@lanostrafamiglia.it
Eleonora Diella
- Recruiting
IRCCS Fondazione Mondino
Pavia, PV, 27100
Angela Berardinelli, angela.berardinelli@mondino.it
Angela Berardinelli
- Recruiting
IRCCS Fondazione Stella Maris
Pisa, PI, 56128
Giada Sgherri, giada.sgherri@unipi.it
Giada Sgherri
- Suspended
Fondazione Don Gnocchi - Centro "S. Maria al Mare"
Salerno, SA, 84131
About this study
Official title: Evaluation of the Impact of a Rehabilitation Intervention Based on Cycling With Virtual Park on Slowing the Functional Motor Decline of Neuromuscular Patients in Developmental Age
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?
Read more
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.
- Being tested
- Dual-task cycling, Standard therapy
- Keywords
- Sports for Persons with Disabilities, Rehabilitation, Neuromuscular Diseases, Dual-Task Exercises, Virtual Reality, Children with Disabilities
- Medical subject headings
- Muscular Dystrophies, Myotonia Congenita, Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-task cyclingDevice
VirtualPark 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 therapyOther
Participants undergo their standard plan: outpatient treatment, if planned, or no treatment.
| Study group | Role | What they receive |
|---|---|---|
| Two-phase arm | Experimental | * 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 for 20 minutes (plus 5-10 minutes of warm-up and 5-10 minutes of cool down). Receives: Device: Dual-task cycling; Other: Standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
Secondary outcomes (5)
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.
Measured: Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
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.
Measured: Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
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.
Measured: Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
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].
Measured: Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
Assisted-6 Minute Cycling Test (A6MWT)
Performance change in the Assisted 6-minute cycling test (A6MCT). The A6MCT is a submaximal endurance test performed by pedaling with a cycle ergometer in passive mode for both upper and lower limbs, specifically created for subjects affected by Duchenne muscular dystrophy, both ambulatory and non-ambulatory. The final score records the number of complete revolutions performed in 6 minutes; the number of revolutions per minute and any breaks requested by the subject are also recorded [27].
Measured: Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start30 Jun 2026
- Primary completionDec 2026 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DystrophinopathyStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants first undergo 3 months of standard therapy, followed by 3 months of intervention with Virtual Park. They act as controls for themselves.
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS National Neurological Institute "C. Mondino" Foundation, IRCCS Eugenio Medea, Fondazione Don Carlo Gnocchi ETS, IRCCS Fondazione Stella Maris
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580365
- Sponsor's protocol ID
- 0057550-28/04/2026
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of a Rehabilitation Intervention Based on Cycling With Virtual Park on Slowing the Functional Motor Decline of Neuromuscular Patients in Developmental Age
- ClinicalTrials.gov ID
- NCT07580365
- Acronym / sponsor ID
- 0057550-28/04/2026
- Keywords
- Sports for Persons with Disabilities, Rehabilitation, Neuromuscular Diseases, Dual-Task Exercises, Virtual Reality, Children with Disabilities
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero AvanzatoUniversity, hospital or other
- Collaborators
- IRCCS National Neurological Institute "C. Mondino" Foundation, IRCCS Eugenio Medea, Fondazione Don Carlo Gnocchi ETS, IRCCS Fondazione Stella Maris
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 12 May 2026 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants first undergo 3 months of standard therapy, followed by 3 months of intervention with Virtual Park. They act as controls for themselves.
| Arm | Type | Receives |
|---|---|---|
| Two-phase arm | Experimental | Device: Dual-task cycling, Other: Standard therapy* 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 for 20 minutes (plus 5-10 minutes of warm-up and 5-10 minutes of cool down). |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Dual-task cyclingVirtualPark 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. | Device | Two-phase arm |
| Standard therapyParticipants undergo their standard plan: outpatient treatment, if planned, or no treatment. | Other | Two-phase arm |
Primary outcome
Motor Function Measure-32 (MFM-32) - Total score
Time frame: Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
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.
5 secondary outcomes
North Star Ambulatory Assessment (NSSA)
Time frame: Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
Timed functional tests (TFTs)
Time frame: Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
6-Minute Walking Test (6MWT)
Time frame: Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
Performance Upper Limb Module 2.0 scale (PUL version 2.0)
Time frame: Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
Assisted-6 Minute Cycling Test (A6MWT)
Time frame: Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-task cycling and Standard therapy in people with Dystrophinopathy and Muscular Dystrophies, run by Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato at 4 sites in Italy.
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 4 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: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Arlati, Bioengineer ((+39)03412350202, sara.arlati@cnr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Function Measure-32 (MFM-32) - Total score (time frame: Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2026.