Clinical trial NCT06560450: Research Report: CERITER Clinical Study - Stride One
Official title: Research Report: CERITER Clinical Study - Stride One
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CVA (Cerebrovascular Accident)
Keywords: CVA (Cerebrovascular Accident)
Gait rehabilitation
Gait analysis
Tele-rehabilitation
Lead sponsor: Ceriter Nederland BV
Sponsor class: INDUSTRY
Collaborators: name: FRAME Jessa Ziekenhuis, Belgium
First posted: 2024-08-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Ten patients were offered therapy using Stride One for one week. Several measurements are performed before the start of the therapy, immediately after the end of the intervention period and 2 days after the end of the therapy.
Primary purpose: TREATMENT

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

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.

Eligibility criteria: Inclusion Criteria:

* CVA, residentially admitted to the rehabilitation center in Herk-de-Stad, Belgium
* Older than 18 years of age
* Gait problems as a result of the CVA
* Able to walk safely and independently (possibly with a walking aid)
* Able to understand and sign an information and consent form

Exclusion Criteria:

* Severe cognitive problems (attention) that make it difficult to understand instructions or follow feedback
* Hearing problem

Primary outcomes:
measure: Complete and correct foot roll-off
timeFrame: 1 week while daily therapy was given
measure: Changed walking speed/greater number of steps per minute
timeFrame: 1 week while daily therapy was given
Secondary outcomes:
measure: Improved functional tests: 5x sit-to-stand (seconds)
timeFrame: Before the start of the therapy, immediately after the end of the intervention period and 2 days after the end of the therapy
measure: Improved functional tests: 3-minute walking test without audio feedback
timeFrame: Before the start of the therapy, immediately after the end of the intervention period and 2 days after the end of the therapy
measure: Improved functional tests: 3-minute walking test with audio feedback
timeFrame: Before the start of the therapy and immediately after the end of the intervention period
measure: Subjective experiences: questionnaires
timeFrame: Post intervention, 2 days after end of the therapy
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Frame, Jessa Ziekenhuis
Study officials:
affiliation: Frame Jessa Ziekenhuis
name: Sarah Meyer
role: STUDY_DIRECTOR
References:
citation: Khoo IH, Marayong P, Krishnan V, Balagtas M, Rojas O, Leyba K. Real-time biofeedback device for gait rehabilitation of post-stroke patients. Biomed Eng Lett. 2017 Jun 7;7(4):287-298. doi: 10.1007/s13534-017-0036-1. eCollection 2017 Nov.
citation: Kwakkel G, Stinear C, Essers B, Munoz-Novoa M, Branscheidt M, Cabanas-Valdes R, Lakicevic S, Lampropoulou S, Luft AR, Marque P, Moore SA, Solomon JM, Swinnen E, Turolla A, Alt Murphy M, Verheyden G. Motor rehabilitation after stroke: European Stroke Organisation (ESO) consensus-based definition and guiding framework. Eur Stroke J. 2023 Dec;8(4):880-894. doi: 10.1177/23969873231191304. Epub 2023 Aug 7.
citation: Kim J, Jung S, Song C. The Effects of Auditory Feedback Gait Training Using Smart Insole on Stroke Patients. Brain Sci. 2021 Oct 21;11(11):1377. doi: 10.3390/brainsci11111377.