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VRehab-SMA Phase 1.2

9. června 2026 aktualizováno: University of Oxford

Virtual Targeted Rehabilitation for Patients With Spinal Muscular Atrophy: Phase 1.2: Proof-of-concept

Spinal muscular atrophy is a genetic disorder characterized by progressive muscle weakness, severely impacting patients' motor abilities. Several disease modifying therapies have been developed to treat Spinal muscular atrophy which have led to new disease trajectories . According to standard of care guidelines, exercise programs should be designed and monitored by a physical therapist and should include exercises to improve daily life activities. Exercises should be adapted to each patient and can be prescribed with an optimal frequency in various ways. However, of patients with Spinal muscular atrophy, only 20% reported access to endurance exercises and only 6% to mixed exercises. This incompliance to standard of care guidelines is due to manpower limitation and difficulties in engaging with young and sometimes highly disabled children. Our group has been pioneering in developing the UK at-home individualised rehabilitation program. To address this challenge, the Investigators propose the development of an innovative, virtual targeted rehabilitation platform specifically designed for young patients with Spinal muscular atrophy. This technology aims to provide a patient-centric, at-home rehabilitation solution, enabling parents/caregivers to facilitate daily exercises in a more accessible and enjoyable manner. This technology would constitute the first of its kind in Spinal muscular atrophy field, involving the integration of augmented electromyography signals and soft robotic haptic devices into a gamified virtual reality environment. By increasing the frequency and quality of exercise interventions at home, this technology has the potential to significantly address the critical unmet need for consistent rehabilitation. This technology will also serve as a clinical outcome measure for continuous home-based assessments of weaker and less functional population in place of hospital-based assessments.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

Spinal muscular atrophy is a genetic disorder where muscles progressively weaken, severely impacting patients' motor abilities eg sitting or walking etc.

Several disease modifying therapies have been developed to treat Spinal muscular atrophy which have led to new disease pathways. For example, previously patients who could not sit can now sit but still not walk. According to standard of care guidelines, exercise programs should be designed and monitored by a physical therapist and should include exercises to improve daily life activities. Exercises should be adapted to each patient and can be prescribed with an optimal frequency in various ways. However in a recent survey, of patients with Spinal muscular atrophy, only 20% report access to endurance exercises and only 6% report mixed exercises. This is due to manpower limitation and difficulties in engaging with young and sometimes highly disabled children.

To address this, the investigators propose the development of an innovative, virtual targeted rehabilitation platform specifically designed for young patients with Spinal muscular atrophy. This technology aims to provide a patient-centric, at-home rehabilitation solution, enabling caregivers to facilitate daily exercises in a more accessible and enjoyable manner. This technology would involve the integration of augmented electromyography signals and soft robotic haptic devices into a game controlled by exercise/movement for children. By increasing the frequency and quality of exercise interventions at home, this technology has the potential to significantly address the critically unmet need for consistent rehabilitation and decrease the burden of hospital-based assessments.

This is a proof of concept study to assess patients with Spinal muscular atrophy desire to use the equipment and the potential benefit this can bring to patients by surveying Spinal muscular atrophy patients about technology and exercise and testing the current equipment in a lab setting.

Typ studie

Intervenční

Zápis (Odhadovaný)

12

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Cohort 1 Inclusion Criteria:

  • Person with SMA

    • A person living with genetically confirmed SMA aged from 12-18 years
    • A good understanding of English or someone who can provide a good understanding of English for me to complete the survey
    • A young person living with SMA from 12-15 years of age and who's caregiver/legal guardian gives consent
    • A young person living with SMA from 16-18 years of age who provide their own consent

Caregiver/ Legal Guardian

  • A caregiver (legal guardian) of child/young person living with SMA aged from 6-18 years old
  • A good understanding of English or someone who can provide a good understanding of English for me to complete the survey

Exclusion Criteria: No exclusion criteria for Cohort 1, other than meeting the inclusion criteria

Cohort 2 Inclusion Criteria:

Participant with SMA aged 6-10 years

  • Genetically confirmed SMA
  • A comprehensive understanding of English
  • Treated with any disease-modifying therapy post-symptomatically
  • Number of SMN2 copies available
  • Functional status available
  • Age: Participants between 6-10 years at Visit 1 (inclusion)
  • Parent(s)/legal guardian(s)/caregiver(s) able to provide written informed consent and child able to provide assent prior to participation in the study

Participant with SMA aged 11-15 years

  • Genetically confirmed SMA
  • A comprehensive understanding of English
  • Treated with any disease-modifying therapy post-symptomatically
  • Number of SMN2 copies available
  • Functional status available
  • Age: Participants between 11-15 years at Visit 1 (inclusion)
  • Parent(s)/legal guardian(s)/caregiver(s) able to provide written informed consent and child able to provide assent prior to participation in the study

Participant with SMA aged 16-18 years

  • Genetically confirmed SMA
  • A comprehensive understanding of English
  • Treated with any disease-modifying therapy post-symptomatically
  • Number of SMN2 copies available
  • Functional status available
  • Age: Participants between 16-18 years at Visit 1 (inclusion)
  • Able to provide written informed consent

Exclusion Criteria:

Any acute or chronic condition which, according to the investigator, significantly interferes with the use of the device (example: Upper limbs injuries interfering with technology, skin conditions preventing the use of electrodes, etc)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Jiný
  • Přidělení: Nerandomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Žádný zásah: Cohort 1(Survey)
Participants will be asked to complete and online survey with 17 questions (with subparts). The first 4 questions will establish their Spinal muscular atrophy condition and their movement levels. The remaining 13 questions will establish their exercise routines and use of technology in daily life. Followed by their preference for gaming, types of games and TV programs they enjoy. The participants will only be asked once to fill in the survey and this will be carried out at their own homes on their own.
Experimentální: Cohort 2 (Testing)
Cohort 2 (Testing) will test out a basic device in a control laboratory environment to determine if further research for long term use and a at home device would be beneficial to patients and not have any adverse effects to their physical health. Participants will be ask to attend a pre-screening video to check eligibility for the study and be consented online at the meeting. Following this meeting 2 visits will be arranged at the University Biomedical engineering lab in Oxford and the participants asked to participate in using the device
Přístroj: VRehab SMA device

The VRehab SMA device includes:

  • A screen to provide visual feedback (like games or animations)
  • Bluetooth-connected EMG sensors to measure muscle activity in the arms
  • A ball to measure grip strength
  • A virtual reality (VR) headset (used only for participants over 10 years of age)

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Cohort 1 (Survey) - To understand current user engagement with exercises and digital games (including time spent and game types) in order to identify and propose suitable activities, games, and tasks for inclusion in the VRehab interface.
Časové okno: At the end of 3 months (+ extension if needed) or completion of 120 surveys in total
Responses to survey
At the end of 3 months (+ extension if needed) or completion of 120 surveys in total
Cohort 2 (Testing) To evaluate the relevance of a virtual rehabilitation interface for treated patients with SMA
Časové okno: through study completion an average of 6 months

Number of patients who rate the device as relevant. Each participant will be asked to rate:

a. The perceived impact of VRehab SMA device on motor skills using the approved Relevance questionnaire
through study completion an average of 6 months

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Cohort 2 (Testing) - To evaluate the satisfaction/experience of a virtual rehabilitation interface for treated patients with SMA
Časové okno: through study completion an average of 6 months

Satisfaction/experience questionnaire. Each participant will be asked to rate:

  1. Feedback on device
  2. Usability
  3. Areas of improvement
through study completion an average of 6 months

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Cohort 2 (Testing) Exploratory objectives - To explore the VRehab device as outcome measure 1
Časové okno: through study completion an average of 6 months

1. Outcome measures used as anchors:

a, Revised upper limb module (RULM): Total score and range of motion as measured by motion capture cameras at V1 and compared with range of motion captured during the use of VRehab SMA device
through study completion an average of 6 months
Cohort 2 (Testing) Exploratory objectives - To explore the VRehab device as outcome measure 2
Časové okno: through study completion an average of 6 months
Myogrip: measured strength value and compare with strength captured during the use of VRehab SMA device
through study completion an average of 6 months
Cohort 2 (Testing) Exploratory objectives -To assess signals of hand strength changes (fatigue).
Časové okno: through study completion an average of 6 months
A Comparison of the pattern and range of maximum grip strength (maximum voluntary contraction (MVC) between the first few visit trials and last few visit trials
through study completion an average of 6 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Oxford

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

27. května 2026

Primární dokončení (Odhadovaný)

1. dubna 2027

Dokončení studie (Odhadovaný)

1. dubna 2027

Termíny zápisu do studia

První předloženo

15. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

5. května 2026

První zveřejněno (Aktuální)

11. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

11. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

9. června 2026

Naposledy ověřeno

1. dubna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • Vrehab- PID19470
  • 26/PR/0281 (Jiný identifikátor: REC)

Plán pro data jednotlivých účastníků (IPD)

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NEROZHODNÝ

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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Podmínky

Vzácné nemoci

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Doplňky stravy

Sponzor / Spolupracovníci

Místa

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