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Acceptability of a study design in people with Parkinson’s disease - a feasibility study

Acceptability of a study design in people with Parkinson’s disease - a feasibility study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00028008
Enrollment
12
Registered
2022-02-07
Start date
2022-01-18
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G20

Interventions

Group 1: Cueing device is turned on Group 2: Cueing device is turned off

Sponsors

IMC University of Applied Sciences Krems
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Parkinson’s disease - Can walk for 2 x 10m without assistance and assistive devices - Shoe sizes from 36 – 47 - FoG assessed with FoG Questionnaire via telephone before declaration of consent) during On-Phase of medication. If the possible participant rates this question Nr.3 with a least 1 point, he/she can be included in the study: “Do you feel that your feet get glued to the floor while walking, making a turn or when trying to initiate walking (freezing)?” 0 Never 1 Very rarely—about once a month 2 Rarely—about once a week 3 Often—about once a day 4 Always—whenever walking

Exclusion criteria

Exclusion criteria: - Guardianship - Cardiac pace maker (due to SVSD) - Deep brain stimulation (due to SVSD) - >135kg body weight (due to sensor insoles) - Wounds or fractures on the sternum or the feet (due to SVSD and sensor insoles) - severe gait impairments where the insoles might increase the risk of fall (due to sensor insoles) - inability of the client to wear closed shoes in combination with the sensor insoles (due to sensor insoles) - Cannot understand or follow the instructions - Pregnancy

Design outcomes

Primary

MeasureTime frame
This is a study where all tests will take place ont he same day. The feasibility of the assessments used will be determined by the completion of the assessment by the participant. If the assessment cannot be completed by 20% of the participants due to any adverse effects or discomfort by the participant, the assessment will be determined “not-feasible” in this setting. These assessments will be conducted directly after the tests have been completed on day.

Secondary

MeasureTime frame
FoG-Score will be used to assess FoG symptoms. Gait analysis will be conducted with the sensor insoles (Focus on stride length, cadence, stride duration) during the 10m walk test. A Patient Global Impression Scale for Severity and Change and a Visual Analogue scale will be used for assessing the subjective difference in completing the 10m walk test and the FoG-Score with and without the cueing device.

Countries

Austria

Contacts

Public ContactAgnes Wilhelm

IMC Fachhochschule Krems

agnes.wilhelm@fh-krems.ac.at+43 2732 802 194

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026