VRehab-SMA Phase 1.2
Virtual Targeted Rehabilitation for Patients With Spinal Muscular Atrophy: Phase 1.2: Proof-of-concept
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Oxford, Reino Unido
- Oxford University
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
Aceita Voluntários Saudáveis
Descrição
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)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Sem intervenção: 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.
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Experimental: 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
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The VRehab SMA device includes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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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.
Prazo: At the end of 3 months (+ extension if needed) or completion of 120 surveys in total
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Responses to survey
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At the end of 3 months (+ extension if needed) or completion of 120 surveys in total
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Cohort 2 (Testing) To evaluate the relevance of a virtual rehabilitation interface for treated patients with SMA
Prazo: through study completion an average of 6 months
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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
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Cohort 2 (Testing) - To evaluate the satisfaction/experience of a virtual rehabilitation interface for treated patients with SMA
Prazo: through study completion an average of 6 months
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Satisfaction/experience questionnaire. Each participant will be asked to rate:
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through study completion an average of 6 months
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
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Cohort 2 (Testing) Exploratory objectives - To explore the VRehab device as outcome measure 1
Prazo: through study completion an average of 6 months
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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
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Cohort 2 (Testing) Exploratory objectives - To explore the VRehab device as outcome measure 2
Prazo: through study completion an average of 6 months
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Myogrip: measured strength value and compare with strength captured during the use of VRehab SMA device
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through study completion an average of 6 months
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Cohort 2 (Testing) Exploratory objectives -To assess signals of hand strength changes (fatigue).
Prazo: through study completion an average of 6 months
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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
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through study completion an average of 6 months
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Vrehab- PID19470
- 26/PR/0281 (Outro identificador: REC)
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