The Ohio State University and the American Physical Therapy Association are joining forces to address pressing needs for children with motor delays. Leveraging telehealth technologies combined with Complex Rehabilitation Technology (CRT), these sponsors are conducting a clinical trial to investigate the effects of stander use in natural environments. This initiative holds promise for improving motor abilities among affected children, particularly those with cerebral palsy or other motor disabilities.
The trial, while still listed as “Not yet recruiting”, highlights how telehealth initiatives could enhance intervention accessibility and outcomes. This research focuses on addressing motor impairments in children from an evidence-based perspective while employing behavioral strategies.
In this article:
- What are the study objectives?
- Who is eligible?
- CRT and regulatory considerations
- FAQ
- Takeaway
- Disclaimer
- Full announcement and link
What are the study objectives?
This trial aims to validate the use of standers, CRT devices designed to support upright posture and mobility. By combining behavioral implementation techniques with remote oversight via telehealth, researchers hope to empower families to integrate therapeutic activities into home settings.
The study’s sponsors emphasize the importance of ecological validity. Conducting interventions in natural environments may provide insights into practical benefits and improve accessibility for children who lack resources to visit clinical facilities physically.
Who is eligible?
The study specifically targets children experiencing motor deficits, such as motor delays or motor disabilities caused primarily by cerebral palsy. Participants will likely undergo a selection process ensuring their needs align with the intervention’s intended outcomes.
While the full inclusion and exclusion criteria are forthcoming, families interested in participating should closely monitor the recruitment information once officially launched.
CRT and regulatory considerations
Complex Rehabilitation Technology (CRT) devices like standers fall under strict regulation. Compliance with medical device safety standards is critical when combining behavioral applications with telehealth technologies.
The sponsors of this trial demonstrate adherence to regulatory expectations, including MDR Annex XIV provisions requiring clear definitions of device purposes, performance thresholds, and risk mitigation strategies in clinical settings.
For families and care teams, understanding the role of CRT in improving life quality holds equal importance to ensuring ethical and performance compliance.
FAQ
- What is the primary intervention?
The study uses standers as the intervention combined with behavioral techniques. - How is telehealth incorporated?
Telehealth ensures remote monitoring and guidance, making interventions accessible for families in natural environments. - Is recruitment open?
At present, the trial is not yet recruiting. Interested families should stay updated through clinical trial platforms. - Which organizations are sponsoring this research?
Ohio State University and the American Physical Therapy Association are the official sponsors. - Who oversees CRT regulation?
CRT devices like standers comply with global medical device standards, including MDR Annex XIV provisions.
Takeaway
Telehealth-enabled CRT interventions provide hope for improving accessibility and therapeutic outcomes for children with motor delays. From a regulatory standpoint, trials like this set benchmarks for implementing complex devices safely and effectively in natural home environments.
Families of children with cerebral palsy or similar disabilities should consider opportunities to participate once recruitment opens. This innovative research could transform rehabilitation strategies to benefit children worldwide.
Disclaimer
This article is intended for informational purposes only and does not constitute legal or clinical advice. Professionals should consult official regulatory guidance or clinical trial documentation for compliance-related decisions.
Full announcement and link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07252713?term=medical+device