Research Report: CERITER Clinical Study - Stride One

August 16, 2024 updated by: Ceriter Nederland BV

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Hasselt, Belgium, 3500
        • Frame, Jessa Ziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Real-time audio feedback
Physiotherapist-defined real-time audio feedback
Device: Stride One
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 week while daily therapy was given
Changed walking speed/greater number of steps per minute
Time Frame: 1 week while daily therapy was given
1 week while daily therapy was given

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ceriter Nederland BV

Collaborators

FRAME Jessa Ziekenhuis, Belgium

Investigators

  • Study Director: Sarah Meyer, Frame Jessa Ziekenhuis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2023

Primary Completion (Actual)

April 29, 2024

Study Completion (Actual)

April 29, 2024

Study Registration Dates

First Submitted

August 8, 2024

First Submitted That Met QC Criteria

August 16, 2024

First Posted (Actual)

August 19, 2024

Study Record Updates

Last Update Posted (Actual)

August 19, 2024

Last Update Submitted That Met QC Criteria

August 16, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVA-STRIDE-1-FRAME01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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