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Usability of a Novel Cueing Device for Patients With Parkinson's Disease (TCP)

Primary Purpose

Freezing of Gait, Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Tactile Cueing Device
Sponsored by
Swiss Federal Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Freezing of Gait

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Rehaklinik Zihlschlacht AGRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Using the Tactile Cueing Device

Outcomes

Primary Outcome Measures

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.
System Usability Scale
Items defined by the System Usability Scale: 5-point Likert scale ('strongly disagree' to 'strongly agree').
Usability
Usability of the cueing device is measured by a self-developed questionnaire.
Acceptance
Acceptance is measured by a self-developed questionnaire.
Frequency using the device
How often the device is used (counts logging protocol).

Secondary Outcome Measures

Walking speed [meters/second]
Calculated by the assessments 10 meter walk test and 2-minute walk test.
Cadence [steps/minute]
Number during 10 meter walk test. Also measured by a system of movement analysis (C-Mill MOTEK).
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).
Step length right/left [in meters]
Measured by a system of movement analysis (C-Mill MOTEK).
Initial step latency [in seconds]
Extracted from video documentation by a blinded rater.
Number of FOG
Extracted from video documentation by a blinded rater.

Full Information

First Posted
June 11, 2020
Last Updated
September 12, 2023
Sponsor
Swiss Federal Institute of Technology
Collaborators
Rehaklinik Zihlschlacht AG
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1. Study Identification

Unique Protocol Identification Number
NCT04459559
Brief Title
Usability of a Novel Cueing Device for Patients With Parkinson's Disease
Acronym
TCP
Official Title
Usability Study of a Novel Tactile Cueing Device for Patients With Parkinson's Disease: A Monocentric Interventional Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2020 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Federal Institute of Technology
Collaborators
Rehaklinik Zihlschlacht AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Freezing of Gait, Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The proposed trial is designed as an explorative, open label, non-randomised, uncontrolled clinical trial.
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Using the Tactile Cueing Device
Intervention Type
Device
Intervention Name(s)
Tactile Cueing Device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Setup cueing device
Description
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.
Time Frame
2 weeks
Title
System Usability Scale
Description
Items defined by the System Usability Scale: 5-point Likert scale ('strongly disagree' to 'strongly agree').
Time Frame
2 weeks
Title
Usability
Description
Usability of the cueing device is measured by a self-developed questionnaire.
Time Frame
2 weeks
Title
Acceptance
Description
Acceptance is measured by a self-developed questionnaire.
Time Frame
2 weeks
Title
Frequency using the device
Description
How often the device is used (counts logging protocol).
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Walking speed [meters/second]
Description
Calculated by the assessments 10 meter walk test and 2-minute walk test.
Time Frame
1 week
Title
Cadence [steps/minute]
Description
Number during 10 meter walk test. Also measured by a system of movement analysis (C-Mill MOTEK).
Time Frame
1 week
Title
Walking distance [in meters]
Description
Measured by a digital measuring wheel during 2-minute walk test. Also measured by a system of movement analysis (C-Mill MOTEK).
Time Frame
1 week
Title
Step length right/left [in meters]
Description
Measured by a system of movement analysis (C-Mill MOTEK).
Time Frame
1 week
Title
Initial step latency [in seconds]
Description
Extracted from video documentation by a blinded rater.
Time Frame
1 week
Title
Number of FOG
Description
Extracted from video documentation by a blinded rater.
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raoul Schweinfurther, M.A.
Phone
+41 71 424 3118
Email
r.schweinfurther@rehaklinik-zihlschlacht.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Carsten Möller, Prof.
Phone
+41 71 424 3021
Email
C.Moeller@rehaklinik-zihlschlacht.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raoul Schweinfurther, M.A.
Organizational Affiliation
Rehaklinik Zihlschlacht AG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehaklinik Zihlschlacht AG
City
Zihlschlacht
State/Province
Thurgau
ZIP/Postal Code
8588
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raoul Schweinfurther, M.A. Sport Science
Phone
+41 71 424 3118
Email
R.Schweinfurther@rehaklinik-zihlschlacht.ch

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19906597
Citation
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.
Results Reference
background
PubMed Identifier
17988925
Citation
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.
Results Reference
background
PubMed Identifier
18668629
Citation
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.
Results Reference
background

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Usability of a Novel Cueing Device for Patients With Parkinson's Disease

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