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VirtualPark_Pediatric

2026年8月7日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

22

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Sara Arlati, Bioengineer
  • 電話番号：(+39)03412350202
  • メール：sara.arlati@cnr.it

研究場所

  • イタリア
    • LC
      • Bosisio Parini、LC、イタリア、23849
    • PI
      • Pisa、PI、イタリア、56128
        • 募集
        • IRCCS Fondazione Stella Maris
        • コンタクト：
        • 主任研究者：
          • Giada Sgherri
    • PV
      • Pavia、PV、イタリア、27100
        • 募集
        • IRCCS Fondazione Mondino
        • コンタクト：
        • 主任研究者：
          • Angela Berardinelli
    • SA
      • Salerno、SA、イタリア、84131
        • 一時停止
        • Fondazione Don Gnocchi - Centro "S. Maria al Mare"

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：支持療法
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Two-phase arm
  • 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).
デバイス：Dual-task cycling
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.
他の：Standard therapy
Participants undergo their standard plan: outpatient treatment, if planned, or no treatment.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Motor Function Measure-32 (MFM-32) - Total score
時間枠：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.
Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)

二次結果の測定

結果測定
メジャーの説明
時間枠
North Star Ambulatory Assessment (NSSA)
時間枠：Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
[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.
Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
Timed functional tests (TFTs)
時間枠：Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
[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.
Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
6-Minute Walking Test (6MWT)
時間枠：Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
[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.
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)
時間枠：Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
[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].
Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
Assisted-6 Minute Cycling Test (A6MWT)
時間枠：Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
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].
Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)

その他の成果指標

結果測定
メジャーの説明
時間枠
NEPSY-II
時間枠：Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)

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)
Endurance
時間枠：Continuously assessed during each training session from Month 3 (T1) to Month 6 (T2).
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.
Continuously assessed during each training session from Month 3 (T1) to Month 6 (T2).
User Engagement Scale-Short Form (UES-SF)
時間枠：Every week (i.e., every 3 sessions) from Month 3 (T1) to Month 6 (T2).
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.
Every week (i.e., every 3 sessions) from Month 3 (T1) to Month 6 (T2).
Device safety
時間枠：From Month 3 (T1) to Month 6 (T2).
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.
From Month 3 (T1) to Month 6 (T2).

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato

協力者

IRCCS Eugenio Medea
IRCCS Fondazione Stella Maris
IRCCS National Neurological Institute "C. Mondino" Foundation
Fondazione Don Carlo Gnocchi ETS

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年6月30日

一次修了 (推定)

2026年12月1日

研究の完了 (推定)

2028年6月1日

試験登録日

最初に提出

2026年5月5日

QC基準を満たした最初の提出物

2026年5月5日

最初の投稿 (実際)

2026年5月12日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月11日

QC基準を満たした最後の更新が送信されました

2026年8月7日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 0057550-28/04/2026

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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