Gait, FestinatingCSO_FOGNCT06204081
Short-Term Effect Of Ceriter Stride One (CSO) on FOG and Falling in pwP
A study testing CSO_without cueing and CSO_cueing in people with Gait, Festinating and Parkinson Disease, run by University Ghent at 1 site in Belgium.
Trial summary
The Ceriter Stride One (CSO) is a "smart sole" with pressure sensors. The sole allows data on the displacement of the body's centre of gravity (COG), as well as spatiotemporal parameters, to be obtained via pressure recordings. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gait, Festinating, Parkinson Disease, Device Adherence
- What is being tested?
- CSO_without cueing and CSO_cueing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteBelgium
- Study dates
- 5 Dec 2023to 14 May 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's disease (or other Parkinsonism)
- gait impairment with freezing of gait (FOG)
- 18-80 years old
- I.C. (informed consent)
- Montreal Cognitive Assessment (MoCA) >25
Who cannot join
- unable to walk 4m without assistance
- MoCA < 25
- no FOG
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploration of the Short-term Effects and User Satisfaction of the Ceriter Stride One (CSO) Regarding the Prevention and Treatment of Freezing or Gait in Persons With Parkinson's Disease (pwP).
The Ceriter Stride One (CSO) is a "smart sole" with pressure sensors. The sole allows data on the displacement of the body's centre of gravity (COG), as well as spatiotemporal parameters, to be obtained via pressure recordings. Logarithms, released on the data captured by the sole, make it possible to recognise propulsion (forward movement of the CG), accompanied by a reduction in step length (festination) or feet remaining standing (freezing of gait). When the system registers incipient propulsion, an audio signal ("stop") is generated via an audio device and app on the mobile phone. The CSO aims to make the pwP stop before balance disturbance can occur, preventing further propulsion and falls.
The aim of the study is to explore the short-term effects of the CSO in terms of reducing (preventing) freezing of gait and fall risk in a pilot group of pwP whose functionality is limited (Hoehn and Yahr 4). Short-term impact on gait (episodes of freezing of gait, mean step length, mean gait speed) will be evaluated and user satisfaction surveyed.
Read the detailed description
There is scientific evidence for making pwP stop at the onset of propulsion (when step length decreases and step frequency increases) in order to get the COG back within the base of support. Similarly, (auditory) cues are recommended to facilitate starting.
These principles are implemented with the CSO : the device makes the pmP stop at onset of propulsion and generates an auditory, rhythmic cue to facilitate starting and walking with larger steps (prevention).
This is an innovative application, not a standard-of-care intervention.
Protocol :
20 persons with Parkinson's disease (H\&Y 4) (attending physical therapy at Movita).
The test proceeds in 3 stages : preparation / gait test / subjective evaluation :
Preparation
- Info / IC
- General data : age, sex, number of years since diagnosis, use of aids, medication, fall incidents last week (fall diary based on fall diary), (last intake) medication and current efficacy (VAS).
- MDS-UPDRS-II (degree of dependence), nFOGQ, Montreal Cognitive Assessment (MOCA).
Clinical gait test :
The soles are placed in the patient's shoes. If the patient uses an assistive device in daily life, the test is performed with an assistive device.
Following procedure is done in a randomized order*:
- Walking without auditory cue: for 3 minutes, the patient is asked to walk back and forth at a comfortable pace on a 4-meter course through a doorway (start : 2 meters before the doorway, stop : 2 meters beyond the doorway) without any auditory support. If no freezing occurs during this period, pwP is asked to turn 360° in the doorway.
The first 1.5 minutes gait is performed without a double task, the next 1.5 minutes with a cognitive double task (100 - 3 = ... - 3 = ... -3 = ...).
- Walking with auditory cues: for 3 minutes the patient is asked to walk back and forth at a comfortable pace along a 4-meter course through a doorway (start : 2 meters in front of the doorway, stop : 2 meters beyond the doorway) with auditory cues given at the occurrence of a freeze. If no FOG occured, the pwP is asked to turn 360° in the doorway.
The first 1.5 minutes gait is performed without a dual task, the next 1.5 minutes with a cognitive dual task (100 - 3 = ... - 3 = ... -3 = ...).
After each condition (with - without auditory cueing) a short break (2 minutes) is taken, during which a Borg scale for fatigue is taken. After the second condition, satisfaction with the effect of the aid is questioned (see below).
The entire gait test is filmed (by a 2nd person). In this way data, including the number of freezing episodes, can be checked.
*Randomization of conditions: per 2 patients. The first patient draws a card indicating whether or not the patient starts with auditory cues while walking. The 2nd patient then starts with the other condition, and so on. Thus we obtain 10 patients starting with the auditory cueing condition and 10 without.
Parameters considered : duration/step, gait asymmetry (pressure of left foot vs. right foot), number of freezing periods, distance walked, number of steps, mean step length.
Satisfaction questions
- On a scale of 1 to 10, how would you rate the level of comfort of the Ceriter Stride One?
- On a scale of 1 to 10, how safe do you feel when using the Ceriter Stride One?
- To what extent do you feel more secure, on a scale of 1 to 10, while walking by using the Ceriter Stride One?
- Open question : do you have any comments, concerns or questions of your own?
- Conditions
- Gait, Festinating, Parkinson Disease, Device Adherence
- Being tested
- CSO_without cueing, CSO_cueing
- Medical subject headings
- Gait Disorders, Neurologic, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSO_without cueingDevice
The sole is worn without using the cueing application
CSO_cueingDevice
The sole is worn with using the cueing application
| Study group | Role | What they receive |
|---|---|---|
| persons with Parkinson's Disease, Hoehn & Yahr stage 4, FOG | Experimental | This group tests first without the use of cues (CSO evaluates gait pattern, but does not adjust), and then with cues. Receives: Device: CSO_without cueing; Device: CSO_cueing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of captured episodes with freezing of gait (FOG)
n (number of captured FOG-episodes : the less, the better)
Measured: 2 times 3 minutes
The number of captured steps
n (number - more steps relate to a better mobility)
Measured: 2 times 3 minutes
The difference between the pressure of steps with left versus right foot; as a measure of gait asymmetry.
mean presure data of left foot versus mean pressure data of right foot
Measured: 2 times 3 minutes
mean step length
mean step length (cm)
Measured: 2 times 3 minutes
Secondary outcomes (1)
users satisfaction
comfort and safety of the tool are questioned on a scale of 1 to 10.
Measured: after testing (5 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start5 Dec 2023
- Primary completion14 May 2024
- Study completion14 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gait, FestinatingStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One experimental group of pwP (H\&Y stage 4, FOG) wear the sole a. 3 min. without using cues when FOG appears and b. 3 min. with using auditive cues when FOG appears. By randomisation of the conditions, the effect of cues on gait is studied.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dirk Cambier, PhD, Principal investigator, UGent, FGE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204081
- Sponsor's protocol ID
- ONZ - 2023 - 0501
- Acronym
- CSO_FOG
- Status last verified
- Jun 2024
- First submitted
- 1 Dec 2023
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zoetewei D, Herman T, Brozgol M, Ginis P, Thumm PC, Ceulemans E, Decaluwe E, Palmerini L, Ferrari A, Nieuwboer A, Hausdorff JM. Protocol for the DeFOG trial: A randomized controlled trial on the effects of smartphone-based, on-demand cueing for freezing of gait in Parkinson's disease. Contemp Clin Trials Commun. 2021 Jun 29;24:100817. doi: 10.1016/j.conctc.2021.100817. eCollection 2021 Dec.
PubMed 34816053
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Short-term Effects and User Satisfaction of the Ceriter Stride One (CSO) Regarding the Prevention and Treatment of Freezing or Gait in Persons With Parkinson's Disease (pwP).
- ClinicalTrials.gov ID
- NCT06204081
- Acronym / sponsor ID
- CSO_FOG / ONZ - 2023 - 0501
- Conditions
- Gait, Festinating, Parkinson Disease, Device Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 14 May 2024 (actual)
- Study completion
- 14 May 2024 (actual)
- First posted
- 12 Jan 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 Ceriter Stride One (CSO) is a "smart sole" with pressure sensors. The sole allows data on the displacement of the body's centre of gravity (COG), as well as spatiotemporal parameters, to be obtained via pressure recordings. Logarithms, released on the data captured by the sole, make it possible to recognise propulsion (forward movement of the CG), accompanied by a reduction in step length (festination) or feet remaining standing (freezing of gait). When the system registers incipient propulsion, an audio signal ("stop") is generated via an audio device and app on the mobile phone. The CSO aims to make the pwP stop before balance disturbance can occur, preventing further propulsion and falls.
The aim of the study is to explore the short-term effects of the CSO in terms of reducing (preventing) freezing of gait and fall risk in a pilot group of pwP whose functionality is limited (Hoehn and Yahr 4). Short-term impact on gait (episodes of freezing of gait, mean step length, mean gait speed) will be evaluated and user satisfaction surveyed.
Detailed description
There is scientific evidence for making pwP stop at the onset of propulsion (when step length decreases and step frequency increases) in order to get the COG back within the base of support. Similarly, (auditory) cues are recommended to facilitate starting.
These principles are implemented with the CSO : the device makes the pmP stop at onset of propulsion and generates an auditory, rhythmic cue to facilitate starting and walking with larger steps (prevention).
This is an innovative application, not a standard-of-care intervention.
Protocol :
20 persons with Parkinson's disease (H\&Y 4) (attending physical therapy at Movita).
The test proceeds in 3 stages : preparation / gait test / subjective evaluation :
Preparation
- Info / IC
- General data : age, sex, number of years since diagnosis, use of aids, medication, fall incidents last week (fall diary based on fall diary), (last intake) medication and current efficacy (VAS).
- MDS-UPDRS-II (degree of dependence), nFOGQ, Montreal Cognitive Assessment (MOCA).
Clinical gait test :
The soles are placed in the patient's shoes. If the patient uses an assistive device in daily life, the test is performed with an assistive device.
Following procedure is done in a randomized order*:
- Walking without auditory cue: for 3 minutes, the patient is asked to walk back and forth at a comfortable pace on a 4-meter course through a doorway (start : 2 meters before the doorway, stop : 2 meters beyond the doorway) without any auditory support. If no freezing occurs during this period, pwP is asked to turn 360° in the doorway.
The first 1.5 minutes gait is performed without a double task, the next 1.5 minutes with a cognitive double task (100 - 3 = ... - 3 = ... -3 = ...).
- Walking with auditory cues: for 3 minutes the patient is asked to walk back and forth at a comfortable pace along a 4-meter course through a doorway (start : 2 meters in front of the doorway, stop : 2 meters beyond the doorway) with auditory cues given at the occurrence of a freeze. If no FOG occured, the pwP is asked to turn 360° in the doorway.
The first 1.5 minutes gait is performed without a dual task, the next 1.5 minutes with a cognitive dual task (100 - 3 = ... - 3 = ... -3 = ...).
After each condition (with - without auditory cueing) a short break (2 minutes) is taken, during which a Borg scale for fatigue is taken. After the second condition, satisfaction with the effect of the aid is questioned (see below).
The entire gait test is filmed (by a 2nd person). In this way data, including the number of freezing episodes, can be checked.
*Randomization of conditions: per 2 patients. The first patient draws a card indicating whether or not the patient starts with auditory cues while walking. The 2nd patient then starts with the other condition, and so on. Thus we obtain 10 patients starting with the auditory cueing condition and 10 without.
Parameters considered : duration/step, gait asymmetry (pressure of left foot vs. right foot), number of freezing periods, distance walked, number of steps, mean step length.
Satisfaction questions
- On a scale of 1 to 10, how would you rate the level of comfort of the Ceriter Stride One?
- On a scale of 1 to 10, how safe do you feel when using the Ceriter Stride One?
- To what extent do you feel more secure, on a scale of 1 to 10, while walking by using the Ceriter Stride One?
- Open question : do you have any comments, concerns or questions of your own?
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One experimental group of pwP (H\&Y stage 4, FOG) wear the sole a. 3 min. without using cues when FOG appears and b. 3 min. with using auditive cues when FOG appears. By randomisation of the conditions, the effect of cues on gait is studied.
| Arm | Type | Receives |
|---|---|---|
| persons with Parkinson's Disease, Hoehn & Yahr stage 4, FOG | Experimental | Device: CSO_without cueing, Device: CSO_cueingThis group tests first without the use of cues (CSO evaluates gait pattern, but does not adjust), and then with cues. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Parkinson's disease (or other Parkinsonism)
- gait impairment with freezing of gait (FOG)
- 18-80 years old
- I.C. (informed consent)
- Montreal Cognitive Assessment (MoCA) >25
Key exclusion criteria (3 listed)
- unable to walk 4m without assistance
- MoCA < 25
- no FOG
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 |
|---|---|---|
| CSO_without cueingThe sole is worn without using the cueing application | Device | persons with Parkinson's Disease, Hoehn & Yahr stage 4, FOG |
| CSO_cueingThe sole is worn with using the cueing application | Device | persons with Parkinson's Disease, Hoehn & Yahr stage 4, FOG |
Primary outcome
The number of captured episodes with freezing of gait (FOG)
Time frame: 2 times 3 minutes
n (number of captured FOG-episodes : the less, the better)
The number of captured steps
Time frame: 2 times 3 minutes
n (number - more steps relate to a better mobility)
The difference between the pressure of steps with left versus right foot; as a measure of gait asymmetry.
Time frame: 2 times 3 minutes
mean presure data of left foot versus mean pressure data of right foot
mean step length
Time frame: 2 times 3 minutes
mean step length (cm)
1 secondary outcome
users satisfaction
Time frame: after testing (5 min)
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 5 Jun 2024.
- Results publication: PubMed 34816053Zoetewei D, Herman T, Brozgol M, Ginis P, Thumm PC, Ceulemans E, Decaluwe E, Palmerini L, Ferrari A, Nieuwboer A, Hausdorff JM. Protocol for the DeFOG trial: A randomized controlled trial on the effects of smartphone-based, on-demand cueing for freezing of gait in Parkinson's disease. Contemp Clin Trials Commun. 2021 Jun 29;24:100817. doi: 10.1016/j.conctc.2021.100817. eCollection 2021 Dec.
- protocol of the DeFOG trialLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Gait, Festinating
Recruiting
The Effect of Different Types of Focus Instructions in Parkinson's Rehabilitation
Parkinson Disease, Cognitive Deficit in Attention
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.
Dirk Cambier, PhD principal investigator
UGent, FGE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CSO_without cueing and CSO_cueing in people with Gait, Festinating and Parkinson Disease, run by University Ghent 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 3 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 5 Jun 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?
The number of captured episodes with freezing of gait (FOG) (time frame: 2 times 3 minutes). The study lists 4 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 NCT06204081, which also lists 1 linked publication.
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 5 Jun 2024; AzTrials last refreshed its copy on 7 Nov 2026.