Frame, Jessa Ziekenhuis
Hasselt, 3500, Belgium
NCT Number: NCT06560450
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
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Hasselt, 3500, Belgium
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Stride One is a smart insole that provides real-time audio feedback (cues) to the patient when performing a certain exercise. The goal of Stride One is to allow patients to practice walking more intensively and with higher quality during rehabilitation.
Time frame: 1 week while daily therapy was given
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.
Time frame: 1 week while daily therapy was given
Time frame: Before the start of the therapy, immediately after the end of the intervention period and 2 days after the end of the therapy
Time frame: Before the start of the therapy, immediately after the end of the intervention period and 2 days after the end of the therapy
Distance in meter + roll-off pattern via CERITER software
Time frame: Before the start of the therapy and immediately after the end of the intervention period
Distance in meter + roll-off pattern and recording of auditory feedback via CERITER software
Time frame: Post intervention, 2 days after end of the therapy
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.
Ceriter Nederland BV
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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