A new wearable device to help patients with Parkinson's disease improve their walking
Usability Study of a Novel Tactile Cueing Device for Patients With Parkinson's Disease: A Monocentric Interventional Study
This study tests a new wearable device to see if it can help people with advanced Parkinson's disease walk better and reduce their risk of falling.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Swiss Federal Institute of Technology Academic / other |
| Locations | 1 site (Zihlschlacht, Thurgau) |
| Trial ID | NCT04459559 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the usability of a novel tactile cueing device designed for patients with advanced Parkinson's disease who experience freezing of gait (FOG). The device is lightweight and easy to handle, providing external cues to improve gait and reduce the risk of falls. Participants will be monitored for their ability to use the device effectively, with assessments based on established movement disorder scales. The study aims to determine the impact of this innovative technology on the quality of life for those affected by Parkinson's disease.
Who should consider this trial
Good fit: Ideal candidates are individuals with advanced Parkinson's disease exhibiting symptoms of hypokinetic movements and freezing of gait.
Not a fit: Patients with severely impaired cognitive skills or those in the advanced stage of Parkinson's disease (HY stage V) may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could significantly enhance mobility and reduce fall risk for patients with Parkinson's disease.
How similar studies have performed: Other studies have shown promise with cueing devices for gait improvement in Parkinson's disease, indicating a potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Zihlschlacht, Thurgau
- Rehaklinik Zihlschlacht AG — Zihlschlacht, Thurgau, Switzerland (Recruiting)
Study contacts
- Principal investigator: Raoul Schweinfurther, M.A. — Rehaklinik Zihlschlacht AG
- Study coordinator: Raoul Schweinfurther, M.A.
- Email: r.schweinfurther@rehaklinik-zihlschlacht.ch
- Phone: +41 71 424 3118
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.