Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-24 @ 5:00 PM
Study NCT ID:
NCT06560450
Status:
COMPLETED
Last Update Posted:
2024-08-19
First Post:
2024-08-08
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Research Report: CERITER Clinical Study - Stride One
Sponsor:
Ceriter Nederland BV
Organization:
Study Overview
Official Title:
Research Report: CERITER Clinical Study - Stride One
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical study is to investigate the short-term impact of the use of Ceriter Stride One on the quality of gait in patients rehabilitating after a cerebrovascular accident (CVA). Stride One is a smart insole that provides real-time audio feedback (cues) to the patient when performing a certain exercise.
The main questions it aims to answer are:
* Will patients with a CVA show a qualitatively better gait pattern after training with a Stride One insole?
* Can patients maintain this improvement in gait pattern without audio feedback at the end of the training?
Participants will
* Receive daily gait rehabilitation using Stride One for 1 week
* The quality of the gait pattern was evaluated at the beginning and at the end of the week, with and without the use of Stride One
* An additional evaluation was performed three to four days after the end of therapy without the use of Stride One
* Immediately after the end of the intervention week, the patient and the treating therapist were asked about their findings regarding the use of Stride One while walking
The main questions it aims to answer are:
* Will patients with a CVA show a qualitatively better gait pattern after training with a Stride One insole?
* Can patients maintain this improvement in gait pattern without audio feedback at the end of the training?
Participants will
* Receive daily gait rehabilitation using Stride One for 1 week
* The quality of the gait pattern was evaluated at the beginning and at the end of the week, with and without the use of Stride One
* An additional evaluation was performed three to four days after the end of therapy without the use of Stride One
* Immediately after the end of the intervention week, the patient and the treating therapist were asked about their findings regarding the use of Stride One while walking
Detailed Description:
Both therapist and patient reported an improvement in the quality of the foot roll-off pattern in 100% of cases. This improvement was also objectively determined in the data measured by Stride One, with an average of 8% improvement on Stride One general quality parameter, and an average of 25% improvement on Stride One specific quality parameter for the specific patient. Furthermore, 89% of patients indicate that using Stride One helps them to understand their physiotherapist better, and 67% of patients indicate that they can practice more and better with Stride One.
Practicing one week with Stride One generates a positive clinical impact on the gait pattern. A lasting improvement in the gait pattern without using Stride One, three to four days after the intervention, could not be demonstrated in this short time period. Further research is needed to evaluate the effect of Stride One after more long-term use.
Additional research questions are suggested.
Practicing one week with Stride One generates a positive clinical impact on the gait pattern. A lasting improvement in the gait pattern without using Stride One, three to four days after the intervention, could not be demonstrated in this short time period. Further research is needed to evaluate the effect of Stride One after more long-term use.
Additional research questions are suggested.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: