VirtualPark_Pediatric
2026년 8월 7일 업데이트: Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato
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?
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.
연구 개요
연구 유형
중재적
등록 (추정된)
22
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Sara Arlati, Bioengineer
- 전화번호: (+39)03412350202
- 이메일: sara.arlati@cnr.it
연구 장소
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LC
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Bosisio Parini, LC, 이탈리아, 23849
- 모병
- IRCCS E. Medea - La Nostra Famiglia
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수석 연구원:
- Eleonora Diella
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연락하다:
- Emilia Biffi
- 이메일: emilia.biffi@lanostrafamiglia.it
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PI
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Pisa, PI, 이탈리아, 56128
- 모병
- IRCCS Fondazione Stella Maris
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연락하다:
- Giada Sgherri
- 이메일: giada.sgherri@unipi.it
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수석 연구원:
- Giada Sgherri
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PV
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Pavia, PV, 이탈리아, 27100
- 모병
- IRCCS Fondazione Mondino
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연락하다:
- Angela Berardinelli
- 이메일: angela.berardinelli@mondino.it
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수석 연구원:
- Angela Berardinelli
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SA
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Salerno, SA, 이탈리아, 84131
- 정지된
- Fondazione Don Gnocchi - Centro "S. Maria al Mare"
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Two-phase arm
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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.
Participants undergo their standard plan: outpatient treatment, if planned, or no treatment.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Motor Function Measure-32 (MFM-32) - Total score
기간: Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
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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.
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Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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North Star Ambulatory Assessment (NSSA)
기간: Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
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[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.
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Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
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Timed functional tests (TFTs)
기간: Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
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[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.
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Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
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6-Minute Walking Test (6MWT)
기간: Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
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[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.
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Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
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Performance Upper Limb Module 2.0 scale (PUL version 2.0)
기간: Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
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[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].
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Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
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Assisted-6 Minute Cycling Test (A6MWT)
기간: Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
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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].
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Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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NEPSY-II
기간: Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
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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. |
Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
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Endurance
기간: Continuously assessed during each training session from Month 3 (T1) to Month 6 (T2).
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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.
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Continuously assessed during each training session from Month 3 (T1) to Month 6 (T2).
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User Engagement Scale-Short Form (UES-SF)
기간: Every week (i.e., every 3 sessions) from Month 3 (T1) to Month 6 (T2).
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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.
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Every week (i.e., every 3 sessions) from Month 3 (T1) to Month 6 (T2).
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Device safety
기간: From Month 3 (T1) to Month 6 (T2).
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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.
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From Month 3 (T1) to Month 6 (T2).
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 6월 30일
기본 완료 (추정된)
2026년 12월 1일
연구 완료 (추정된)
2028년 6월 1일
연구 등록 날짜
최초 제출
2026년 5월 5일
QC 기준을 충족하는 최초 제출
2026년 5월 5일
처음 게시됨 (실제)
2026년 5월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 7일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 0057550-28/04/2026
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .