VRehab-SMA Phase 1.2
Virtual Targeted Rehabilitation for Patients With Spinal Muscular Atrophy: Phase 1.2: Proof-of-concept
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Oxford, Reino Unido
- Oxford University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Sin intervención: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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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.
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Cohort 2 (Testing) - To evaluate the satisfaction/experience of a virtual rehabilitation interface for treated patients with SMA
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Cohort 2 (Testing) Exploratory objectives - To explore the VRehab device as outcome measure 1
Periodo de tiempo: 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
Periodo de tiempo: 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).
Periodo de tiempo: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
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Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Vrehab- PID19470
- 26/PR/0281 (Otro identificador: REC)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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