Freezing of GaitTCPNCT04459559
Usability of a Novel Cueing Device for Patients With Parkinson's Disease
A study testing Tactile Cueing Device in people with Freezing of Gait and Parkinson Disease, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial summary
Hypokinetic gait disorder and Freezing of Gait (FOG) are frequent symptoms in the advanced stage of Parkinson's disease (PD). These impair quality of life and significantly increase the risk of falls. External movement pacemakers have been developed to improve gait and avert FOG by cueing strategies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Freezing of Gait, Parkinson Disease
- What is being tested?
- Tactile Cueing Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Nov 2020to 31 Dec 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
- Include patients who suffer from advanced PD. Characteristic symptoms of parkinsonian gait like hypokinetic movements and/or FOG have to be present.
- Parkinsonian gait is measured by the following items of the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS): item 2.12, item 2.13, item 3.10 and item 3.11. The Hoehn and Yahr (HY) stage during ON is 1-4/5.
- MoCA ≥ 22/30.
- Participant has signed the informed consent.
Who cannot join
- Inability of the participant to understand the IC or to follow the procedures of the study (as judged by the Qualified Physician).
- Significantly, impaired cognitive skills render the participant unable to use the TCD.
- Presence of severe motor fluctuations and severely impaired walking ability as defined by HY stage V during ON.
- Clinically relevant skin lesions on the wrist or fixation points (usually the thighs).
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Rehaklinik Zihlschlacht AG
Zihlschlacht, Thurgau, 8588
Raoul Schweinfurther, M.A. Sport Science, +41 71 424 3118, R.Schweinfurther@rehaklinik-zihlschlacht.ch
About this study
Official title: Usability Study of a Novel Tactile Cueing Device for Patients With Parkinson's Disease: A Monocentric Interventional Study
Hypokinetic gait disorder and Freezing of Gait (FOG) are frequent symptoms in the advanced stage of Parkinson's disease (PD). These impair quality of life and significantly increase the risk of falls. External movement pacemakers have been developed to improve gait and avert FOG by cueing strategies. The investigators developed a smart, small and lightweight, easy-to-handle wearable tactile cueing device (TCD), consisting of a control unit, two pulse generators and a battery-driven power supply. The device is programmed via a Graphical User Interface (GUI).
- Conditions
- Freezing of Gait, Parkinson Disease
- Being tested
- Tactile Cueing Device
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tactile Cueing DeviceDevice
Each participant receives an individual training on how to use the Tactile Cueing Device and the set-up of the TCD will be done according to the results of a 10MWT and the participant's preferences. Gait assessments with an activated or deactivated TCD are executed using the Timed Up and Go test, the 2-Minute Waling test and a treadmill (C-Mill). Also a long-term test run of the TCD during one day is planned.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Using the Tactile Cueing Device Receives: Device: Tactile Cueing Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Setup cueing device
Time needed for the setup [in seconds] and the variations of the different setup parameters (cueing length [seconds], cueing strength [% of maximum], cueing cadence [count/minutes]) between the days of usage. Overall descriptive summary of the variation between the different setup parameters during the days of usage.
Measured: 2 weeks
System Usability Scale
Items defined by the System Usability Scale: 5-point Likert scale ('strongly disagree' to 'strongly agree').
Measured: 2 weeks
Usability
Usability of the cueing device is measured by a self-developed questionnaire.
Measured: 2 weeks
Acceptance
Acceptance is measured by a self-developed questionnaire.
Measured: 2 weeks
Frequency using the device
How often the device is used (counts logging protocol).
Measured: 2 weeks
Secondary outcomes (6)
Walking speed [meters/second]
Calculated by the assessments 10 meter walk test and 2-minute walk test.
Measured: 1 week
Cadence [steps/minute]
Number during 10 meter walk test. Also measured by a system of movement analysis (C-Mill MOTEK).
Measured: 1 week
Walking distance [in meters]
Measured by a digital measuring wheel during 2-minute walk test. Also measured by a system of movement analysis (C-Mill MOTEK).
Measured: 1 week
Step length right/left [in meters]
Measured by a system of movement analysis (C-Mill MOTEK).
Measured: 1 week
Initial step latency [in seconds]
Extracted from video documentation by a blinded rater.
Measured: 1 week
Number of FOG
Extracted from video documentation by a blinded rater.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start16 Nov 2020
- Primary completion30 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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 Freezing of GaitStudies 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
- The proposed trial is designed as an explorative, open label, non-randomised, uncontrolled clinical trial.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Rehaklinik Zihlschlacht AG
- Responsible party
- Sponsor
- Investigators
- Raoul Schweinfurther, M.A., Principal investigator, Rehaklinik Zihlschlacht AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04459559
- Sponsor's protocol ID
- RZS_01_2020
- Acronym
- TCP
- Status last verified
- Jan 2024
- First submitted
- 11 Jun 2020
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bachlin M, Plotnik M, Roggen D, Maidan I, Hausdorff JM, Giladi N, Troster G. Wearable assistant for Parkinson's disease patients with the freezing of gait symptom. IEEE Trans Inf Technol Biomed. 2010 Mar;14(2):436-46. doi: 10.1109/TITB.2009.2036165. Epub 2009 Nov 10.
PubMed 19906597Baker K, Rochester L, Nieuwboer A. The effect of cues on gait variability--reducing the attentional cost of walking in people with Parkinson's disease. Parkinsonism Relat Disord. 2008;14(4):314-20. doi: 10.1016/j.parkreldis.2007.09.008. Epub 2007 Nov 7.
PubMed 17988925Giladi N, Nieuwboer A. Understanding and treating freezing of gait in parkinsonism, proposed working definition, and setting the stage. Mov Disord. 2008;23 Suppl 2:S423-5. doi: 10.1002/mds.21927. No abstract available.
PubMed 18668629
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability Study of a Novel Tactile Cueing Device for Patients With Parkinson's Disease: A Monocentric Interventional Study
- ClinicalTrials.gov ID
- NCT04459559
- Acronym / sponsor ID
- TCP / RZS_01_2020
- Conditions
- Freezing of Gait, Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- Rehaklinik Zihlschlacht AG
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Jul 2020 (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.
Hypokinetic gait disorder and Freezing of Gait (FOG) are frequent symptoms in the advanced stage of Parkinson's disease (PD). These impair quality of life and significantly increase the risk of falls. External movement pacemakers have been developed to improve gait and avert FOG by cueing strategies. The investigators developed a smart, small and lightweight, easy-to-handle wearable tactile cueing device (TCD), consisting of a control unit, two pulse generators and a battery-driven power supply. The device is programmed via a Graphical User Interface (GUI).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The proposed trial is designed as an explorative, open label, non-randomised, uncontrolled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Tactile Cueing DeviceUsing the Tactile Cueing Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Include patients who suffer from advanced PD. Characteristic symptoms of parkinsonian gait like hypokinetic movements and/or FOG have to be present.
- Parkinsonian gait is measured by the following items of the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS): item 2.12, item 2.13, item 3.10 and item 3.11. The Hoehn and Yahr (HY) stage during ON is 1-4/5.
- MoCA ≥ 22/30.
- Participant has signed the informed consent.
Key exclusion criteria (4 listed)
- Inability of the participant to understand the IC or to follow the procedures of the study (as judged by the Qualified Physician).
- Significantly, impaired cognitive skills render the participant unable to use the TCD.
- Presence of severe motor fluctuations and severely impaired walking ability as defined by HY stage V during ON.
- Clinically relevant skin lesions on the wrist or fixation points (usually the thighs).
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 |
|---|---|---|
| Tactile Cueing DeviceEach participant receives an individual training on how to use the Tactile Cueing Device and the set-up of the TCD will be done according to the results of a 10MWT and the participant's preferences. Gait assessments with an activated or deactivated TCD are executed using the Timed Up and Go test, the 2-Minute Waling test and a treadmill (C-Mill). Also a long-term test run of the TCD during one day is planned. | Device | Intervention |
Primary outcome
Setup cueing device
Time frame: 2 weeks
Time needed for the setup [in seconds] and the variations of the different setup parameters (cueing length [seconds], cueing strength [% of maximum], cueing cadence [count/minutes]) between the days of usage. Overall descriptive summary of the variation between the different setup parameters during the days of usage.
System Usability Scale
Time frame: 2 weeks
Items defined by the System Usability Scale: 5-point Likert scale ('strongly disagree' to 'strongly agree').
Usability
Time frame: 2 weeks
Usability of the cueing device is measured by a self-developed questionnaire.
Acceptance
Time frame: 2 weeks
Acceptance is measured by a self-developed questionnaire.
Frequency using the device
Time frame: 2 weeks
How often the device is used (counts logging protocol).
6 secondary outcomes
Walking speed [meters/second]
Time frame: 1 week
Cadence [steps/minute]
Time frame: 1 week
Walking distance [in meters]
Time frame: 1 week
Step length right/left [in meters]
Time frame: 1 week
Initial step latency [in seconds]
Time frame: 1 week
Number of FOG
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Background: PubMed 19906597Bachlin M, Plotnik M, Roggen D, Maidan I, Hausdorff JM, Giladi N, Troster G. Wearable assistant for Parkinson's disease patients with the freezing of gait symptom. IEEE Trans Inf Technol Biomed. 2010 Mar;14(2):436-46. doi: 10.1109/TITB.2009.2036165. Epub 2009 Nov 10.
- Background: PubMed 17988925Baker K, Rochester L, Nieuwboer A. The effect of cues on gait variability--reducing the attentional cost of walking in people with Parkinson's disease. Parkinsonism Relat Disord. 2008;14(4):314-20. doi: 10.1016/j.parkreldis.2007.09.008. Epub 2007 Nov 7.
- Background: PubMed 18668629Giladi N, Nieuwboer A. Understanding and treating freezing of gait in parkinsonism, proposed working definition, and setting the stage. Mov Disord. 2008;23 Suppl 2:S423-5. doi: 10.1002/mds.21927. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Freezing of Gait
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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.
Raoul Schweinfurther, M.A. principal investigator
Rehaklinik Zihlschlacht AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tactile Cueing Device in people with Freezing of Gait and Parkinson Disease, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 12 Jan 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raoul Schweinfurther, M.A. (+41 71 424 3118, r.schweinfurther@rehaklinik-zihlschlacht.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Setup cueing device (time frame: 2 weeks). The study lists 5 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 NCT04459559, 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 12 Jan 2024.