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Completed

NCT Number: NCT06560450

Research Report: CERITER Clinical Study - Stride One

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Frame, Jessa Ziekenhuis

Hasselt, 3500, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stride One

Device

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.

Primary outcomes

  1. Complete and correct foot roll-off

    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.

  2. Changed walking speed/greater number of steps per minute

    Time frame: 1 week while daily therapy was given

Secondary outcomes

  1. Improved functional tests: 5x sit-to-stand (seconds)

    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

    • 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
  2. Improved functional tests: 3-minute walking test without audio feedback

    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

  3. Improved functional tests: 3-minute walking test with audio feedback

    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

  4. Subjective experiences: questionnaires

    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.

Sponsors and collaborators

Lead sponsor

Ceriter Nederland BV

Industry

Collaborators

  • FRAME Jessa Ziekenhuis, Belgium

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 19, 2024
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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