Research Report: CERITER Clinical Study - Stride One
NCT Number: NCT06560450
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: CVA (Cerebrovascular Accident)
Interventions: DEVICE: Stride One
Sponsor: Ceriter Nederland BV
Collaborators: FRAME Jessa Ziekenhuis, Belgium
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-12-18
Completion Date: 2024-04-29
Locations: Frame, Jessa Ziekenhuis, Hasselt, 3500, Belgium

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

Primary Outcome Measures: Complete and correct foot roll-off, The first primary endpoint of the study is the complete and correct foot roll-off (detected and interpreted in the Ceriter platform). Stride One provides auditory feedback to the patient, stimulating the patient to achieve a good roll-off of the foot. For each step it measures whether a correct heel-strike, mid-stance and terminal stance are achieved. The aim of Stride One is to teach patients to place their feet correctly, in order to obtain a better roll- off, using positive audio feedback., 1 week while daily therapy was given|Changed walking speed/greater number of steps per minute, 1 week while daily therapy was given
Secondary Outcome Measures: Improved functional tests: 5x sit-to-stand (seconds), • 3-minute walking test with audio feedback (distance in meter + roll-off pattern and Recording of auditory feedback via CERITER software), only at T1 and T2, Before the start of the therapy, immediately after the end of the intervention period and 2 days after the end of the therapy|Improved functional tests: 3-minute walking test without audio feedback, Distance in meter + roll-off pattern via CERITER software, Before the start of the therapy, immediately after the end of the intervention period and 2 days after the end of the therapy|Improved functional tests: 3-minute walking test with audio feedback, Distance in meter + roll-off pattern and recording of auditory feedback via CERITER software, Before the start of the therapy and immediately after the end of the intervention period|Subjective experiences: questionnaires, 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., Post intervention, 2 days after end of the therapy