This report reviews a not yet recruiting clinical trial testing spiral strapping devices in unilateral spastic cerebral palsy to assess potential effects on hand grip strength and upper limb function.
On 2026 02 19 the ClinicalTrials.gov record NCT07418710 lists a not yet recruiting study that pairs two spiral based devices with a structured home based rehabilitation program. The sponsor is Abant Izzet Baysal University. This entry signals interest from clinical, quality and regulatory teams who monitor medical device innovations in pediatric neurology and rehabilitation.
What is the study?
The ClinicalTrials.gov entry NCT07418710 describes a not yet recruiting study focused on unilateral spastic cerebral palsy. The documented conditions include cerebral palsy with emphasis on hand grip strength and upper extremity function. The trial integrates two devices the TheraTogs spiral strapping system and the TogRite spiral strapping system along with a behavioral component described as Upper Limb Rehabilitation and Home Exercise Program. The record names spasticity as a condition of interest and includes a behavioral component in addition to device based intervention.
What is the scope of the study?
The record signals a device based rehabilitation approach rather than a pharmacological or surgical intervention and aims to assess device performance and safety in a pediatric population with unilateral involvement. The study is not yet recruiting which means no participants are currently enrolled and no results are available from this entry.
Which devices are involved?
The interventions listed include two spiral strapping systems TheraTogs and TogRite. Each device is classified as a medical device in the context of rehabilitation hardware. A behavioral component the Upper Limb Rehabilitation and Home Exercise Program is included to support functional outcomes outside device use alone. No explicit device claims are made in this record beyond intended use for upper limb function in CP.
Status and sponsor
The trial status is Not yet recruiting, indicating that enrollment has not started. The sponsor listed is Abant Izzet Baysal University. The entry warrants ongoing monitoring as the sponsor may update the record with recruitment status results or protocol changes. The presence of the clinical trial record on ClinicalTrials.gov supports regulatory transparency and aligns with MDR expectations for premarket device evaluation.
Regulatory implications
The entry highlights a study design that uses two spiral strapping devices in combination with a home exercise program. This pattern fits early stage device evaluation intended to establish safety and basic performance in a pediatric rehabilitation context. The manufacturer statements are not present in this record; the information reflects the sponsor and device names as listed on the ClinicalTrials.gov entry. For professionals, this record can inform regulatory mapping for post market surveillance and potential future submissions depending on study results. Related posts may provide additional regulatory context here and here. The external link to the trial record is available at ClinicalTrials.gov.
Impact on care
If future results show safety and meaningful performance, spiral strapping devices could become part of rehabilitation options for children with unilateral spastic CP. The combination of a device driven approach and a home exercise program aligns with a patient centered model that emphasizes at home practice. The sponsor’s involvement underscores regulatory interest in pediatric device development for upper limb function and spasticity management.
FAQ
- 1. What devices are being evaluated? The TheraTogs spiral strapping system and the TogRite spiral strapping system are listed as device interventions.
- 2. What is the recruitment status? The entry notes Not yet recruiting, indicating enrollment has not started.
- 3. Who is sponsoring the study? Abant Izzet Baysal University is listed as sponsor.
- 4. Where can I find the trial record? The ClinicalTrials.gov page is available at https://clinicaltrials.gov/study/NCT07418710?term=medical+device.
- 5. What is the purpose of the home exercise program? The Home Exercise Program is included to support upper limb rehabilitation alongside device use.
Conclusion and next steps
This entry provides a regulatory snapshot of a not yet recruiting trial evaluating spiral strapping devices for unilateral spastic CP. Stakeholders should monitor updates from the sponsor and ClinicalTrials.gov for enrollment status results and protocol changes. The availability of the device names in the record should be considered in regulatory mapping for future submissions and post market planning.
Disclaimer
This information is intended for professional use and does not constitute legal advice. It should not replace official regulatory guidance or device labeling.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07418710?term=medical+device