- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04459559
Usability of a Novel Cueing Device for Patients With Parkinson's Disease (TCP)
January 11, 2024 updated by: Swiss Federal Institute of Technology
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).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
16
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 Contact
- Name: Raoul Schweinfurther, M.A.
- Phone Number: +41 71 424 3118
- Email: r.schweinfurther@rehaklinik-zihlschlacht.ch
Study Contact Backup
- Name: Carsten Möller, Prof.
- Phone Number: +41 71 424 3021
- Email: C.Moeller@rehaklinik-zihlschlacht.ch
Study Locations
-
-
Thurgau
-
Zihlschlacht, Thurgau, Switzerland, 8588
- Recruiting
- Rehaklinik Zihlschlacht AG
-
Contact:
- Raoul Schweinfurther, M.A. Sport Science
- Phone Number: +41 71 424 3118
- Email: R.Schweinfurther@rehaklinik-zihlschlacht.ch
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
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 |
---|---|
Experimental: Intervention
Using the Tactile Cueing Device
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 weeks
|
System Usability Scale
Time Frame: 2 weeks
|
Items defined by the System Usability Scale: 5-point Likert scale ('strongly disagree' to 'strongly agree').
|
2 weeks
|
Usability
Time Frame: 2 weeks
|
Usability of the cueing device is measured by a self-developed questionnaire.
|
2 weeks
|
Acceptance
Time Frame: 2 weeks
|
Acceptance is measured by a self-developed questionnaire.
|
2 weeks
|
Frequency using the device
Time Frame: 2 weeks
|
How often the device is used (counts logging protocol).
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Walking speed [meters/second]
Time Frame: 1 week
|
Calculated by the assessments 10 meter walk test and 2-minute walk test.
|
1 week
|
Cadence [steps/minute]
Time Frame: 1 week
|
Number during 10 meter walk test.
Also measured by a system of movement analysis (C-Mill MOTEK).
|
1 week
|
Walking distance [in meters]
Time Frame: 1 week
|
Measured by a digital measuring wheel during 2-minute walk test.
Also measured by a system of movement analysis (C-Mill MOTEK).
|
1 week
|
Step length right/left [in meters]
Time Frame: 1 week
|
Measured by a system of movement analysis (C-Mill MOTEK).
|
1 week
|
Initial step latency [in seconds]
Time Frame: 1 week
|
Extracted from video documentation by a blinded rater.
|
1 week
|
Number of FOG
Time Frame: 1 week
|
Extracted from video documentation by a blinded rater.
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Raoul Schweinfurther, M.A., Rehaklinik Zihlschlacht AG
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
- Baker 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.
- 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.
- Giladi 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. Erratum In: Mov Disord. 2008 Aug 15;23(11):1639-40.
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)
November 16, 2020
Primary Completion (Estimated)
December 30, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
June 11, 2020
First Submitted That Met QC Criteria
July 3, 2020
First Posted (Actual)
July 7, 2020
Study Record Updates
Last Update Posted (Actual)
January 12, 2024
Last Update Submitted That Met QC Criteria
January 11, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RZS_01_2020
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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