Research Report: CERITER Clinical Study - Stride One

NCT06560450 | Completed

• 1 other identifier: CVA-STRIDE-1-FRAME01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

CVA (Cerebrovascular Accident)

Keywords

CVA (Cerebrovascular Accident); Gait rehabilitation; Gait analysis; Tele-rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

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

  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

  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

  Before the start of the therapy and immediately after the end of the intervention period

• Subjective experiences: questionnaires

  Post intervention, 2 days after end of the therapy

Study Arms (1)

Real-time audio feedback

OTHER

Physiotherapist-defined real-time audio feedback

Device: Stride One

Interventions

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.

Real-time audio feedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ceriter Nederland BV: lead
• FRAME Jessa Ziekenhuis, Belgium: collaborator

Study Sites (1)

Frame, Jessa Ziekenhuis

Hasselt, 3500, Belgium

Location

Related Publications (3)

• 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.

  PMID: 30603178 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.

  PMID: 37548025 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.

  PMID: 34827376 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sarah Meyer

  Frame Jessa Ziekenhuis

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 19, 2024
• Study Start: December 18, 2023
• Primary Completion: April 29, 2024
• Study Completion: April 29, 2024
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)