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| Name | Class |
|---|---|
| FRAME Jessa Ziekenhuis, Belgium | UNKNOWN |
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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:
Participants will
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real-time audio feedback | Other | Physiotherapist-defined real-time audio feedback |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Meyer | Frame Jessa Ziekenhuis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Frame, Jessa Ziekenhuis | Hasselt | 3500 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30603178 | Background | 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. | |
| 37548025 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 11, 2023 | Aug 8, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
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| 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 |
| 34827376 | Background | 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |