CVA (Cerebrovascular Accident)NCT06560450
Research Report: CERITER Clinical Study - Stride One
A study testing Stride One in people with CVA (Cerebrovascular Accident), run by Ceriter Nederland BV at 1 site in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CVA (Cerebrovascular Accident)
- What is being tested?
- Stride One
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Dec 2023to 29 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Severe cognitive problems (attention) that make it difficult to understand instructions or follow feedback
- Hearing problem
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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
Read the 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.
- Conditions
- CVA (Cerebrovascular Accident)
- Being tested
- Stride One
- Keywords
- CVA (Cerebrovascular Accident), Gait rehabilitation, Gait analysis, Tele-rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stride OneDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Real-time audio feedback | Other | Physiotherapist-defined real-time audio feedback Receives: Device: Stride One |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week while daily therapy was given
Changed walking speed/greater number of steps per minute
Measured: 1 week while daily therapy was given
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: Post intervention, 2 days after end of the therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start18 Dec 2023
- Primary completion29 Apr 2024
- Study completion29 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CVA (Cerebrovascular Accident)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ceriter Nederland BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jessa Hospital
- Responsible party
- Sponsor
- Investigators
- Sarah Meyer, Study director, Frame Jessa Ziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06560450
- Sponsor's protocol ID
- CVA-STRIDE-1-FRAME01
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30603178Kwakkel 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.
PubMed 37548025Kim 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.
PubMed 34827376
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Report: CERITER Clinical Study - Stride One
- ClinicalTrials.gov ID
- NCT06560450
- Acronym / sponsor ID
- CVA-STRIDE-1-FRAME01
- Conditions
- CVA (Cerebrovascular Accident)
- Keywords
- CVA (Cerebrovascular Accident), Gait rehabilitation, Gait analysis, Tele-rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Ceriter Nederland BVIndustry (pharma, biotech, devices)
- Collaborators
- Jessa Hospital
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 29 Apr 2024 (actual)
- Study completion
- 29 Apr 2024 (actual)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Real-time audio feedback | Other | Device: Stride OnePhysiotherapist-defined real-time audio feedback |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Severe cognitive problems (attention) that make it difficult to understand instructions or follow feedback
- Hearing problem
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stride OneStride 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. | Device | Real-time audio feedback |
Primary outcome
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.
Changed walking speed/greater number of steps per minute
Time frame: 1 week while daily therapy was given
4 secondary outcomes
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
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
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
Subjective experiences: questionnaires
Time frame: Post intervention, 2 days after end of the therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Background: PubMed 30603178Khoo 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.
- Background: PubMed 37548025Kwakkel 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.
- Background: PubMed 34827376Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Meyer study director
Frame Jessa Ziekenhuis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stride One in people with CVA (Cerebrovascular Accident), run by Ceriter Nederland BV at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete and correct foot roll-off (time frame: 1 week while daily therapy was given). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06560450, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.