Vibrating socks at home for Parkinson’s Disease

Vibrating socks as a home-based tactile cueing device for Parkinson's disease.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24575

Enrollment

Registered

2021-02-23

Start date

2021-03-01

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

Parkinson's disease

Interventions

Vibrating socks, a new home-based tactile cueing device.

Eligibility

Inclusion criteria

Inclusion criteria: Idiopathic Parkinson’s disease. Recent history of disabling/regular freezing of gait (defined as presence of FOG several times a day in the past month and lasting longer than 1 second and verified objectively by an experienced neurologist). Patients who previously displayed alleviation of gait disturbances when using the vibrating socks in the ongoing study (NL68729.044.19) . Patients who show or expect a benefit of the vibrating socks during a screening test.

Exclusion criteria

Exclusion criteria: Gait impairments as a result of any other factor than Parkinson’s disease. Sensory impairments (e.g. due to polyneuropathy) hampering patients to perceive the vibration of the socks. Cognitive impairments that causes the patient to be unable to understand the research purpose and accompanying instructions. Patients who already use devices that aim to reduce FOG (e.g. Parkinson’s walker). Such devices may interfere with the study results. Patients who wear compression stockings.

Design outcomes

Primary

Measure	Time frame
To evaluate the usability of vibrating socks as a home-based cueing device in patients with Parkinson’s disease (PD).	—

Secondary

Measure	Time frame
To evaluate patient satisfaction about the vibrating socks as a home-based cueing device. To evaluate the effect of the vibrating socks in the home environment on the physical activity levels of the patients. To evaluate the effect of the vibrating socks in the home environment on freezing severity measured by the NFOGQ (weekly instead of monthly). To evaluate the effect of the vibrating socks in the home environment on the occurrence of self-reported falls/near falls by the patients. To evaluate the long-term effect of the vibrating socks on several gait parameters in the home environment measured by a 3D accelerometer/gyroscope (velocity, step time, step time asymmetry, and cadence), an ECG sensor in combination with the 3D accelerometer/gyroscope (freezing of gait by comparing heart rate with velocity) and smart insoles (step time, step type asymmetry, cadence, and relative durations of the single and double limb support phases).	—

Measure

Time frame

To evaluate patient satisfaction about the vibrating socks as a home-based cueing device. To evaluate the effect of the vibrating socks in the home environment on the physical activity levels of the patients. To evaluate the effect of the vibrating socks in the home environment on freezing severity measured by the NFOGQ (weekly instead of monthly). To evaluate the effect of the vibrating socks in the home environment on the occurrence of self-reported falls/near falls by the patients. To evaluate the long-term effect of the vibrating socks on several gait parameters in the home environment measured by a 3D accelerometer/gyroscope (velocity, step time, step time asymmetry, and cadence), an ECG sensor in combination with the 3D accelerometer/gyroscope (freezing of gait by comparing heart rate with velocity) and smart insoles (step time, step type asymmetry, cadence, and relative durations of the single and double limb support phases).

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Contacts

Public ContactMarleen C`. Tjepkema-Cloostermans

Medisch Spectrum Twente

m.tjepkema-cloostermans@mst.nl+31 53 487 2850

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)