NCT04746846

SCH: Context-aware Freezing of Gait Mitigation in Real-world Setting

Completed Results posted Last updated 22 August 2025

What this trial tests

trial testing UG motion sensor with PDVibe3 in Parkinson Disease in 12 participants. Completed in 10 March 2025.

Timeline

11 June 2021

Primary endpoint
10 March 2025

10 March 2025

Quick facts

Lead sponsor	Virginia Commonwealth University
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	12
Start date	11 June 2021
Primary completion	10 March 2025
Estimated completion	10 March 2025
Sites	1 location across United States

Drugs / interventions tested

• UG motion sensor with PDVibe3

Conditions studied

• Parkinson Disease — all drugs for Parkinson Disease →

Sponsor

Virginia Commonwealth University

Who can join

18 and older, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Freezing of Gait (FoG) Episodes Primary · Baseline to final walk task - up to 5 hours

Participants will be videotaped during each walking task and the number of FoG episodes will be counted. Change in number of FoG episodes will be calculated by subtracting the average number of FoG episodes while experiencing vibration vs the number of episodes without vibration. For this test, the null hypothesis of no difference between the treatments versus the alternative hypothesis that the two groups differed.

no vibration 540 degree turn/number of freezes

Group	Value	95% CI
Vibration Therapy	3.75	± .765

vibration 540 degree turn/number of freezes

Group	Value	95% CI
Vibration Therapy	5.17	± .765

no vibration narrow path/number of freezes

Group	Value	95% CI
Vibration Therapy	4.0	± 1.205

vibration narrow path/number of freezes

Group	Value	95% CI
Vibration Therapy	3.63	± 1.205

Duration of Freezing of Gait (FoG) Episodes. Primary · Baseline to final walk task - up to 5 hours

Participants will be videotaped during each walking task and the duration of each FoG episodes will be calculated. Change in duration of FoG episodes will be calculated by subtracting the average duration of FoG episodes while experiencing vibration vs the average duration without vibration.

540 degree turn/no vibration/ total freezing time

Group	Value	95% CI
Vibration Therapy	47.67	± 12.06

540 degree turn/ vibration/ total freezing time

Group	Value	95% CI
Vibration Therapy	52.14	± 12.06

Narrow path/no vibration/ total freezing time

Group	Value	95% CI
Vibration Therapy	34.565	± 17.2

Narrow path/ vibration/ total freezing time

Group	Value	95% CI
Vibration Therapy	43.505	± 17.2

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline to final walk test, up to 5 hours. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Vibration Therapy

Serious: 0/12 (0%)

Deaths: 0/12

Other adverse events (1 terms — click to expand)

Reaction	System	Vibration Therapy
Fall	Musculoskeletal and connective tissue disorders	—

Data from ClinicalTrials.gov NCT04746846 adverse events section.

Sponsor's own description

People with Parkinson's disease (PD) may experience a walking problem called freezing of gait (FoG) that can interfere with the person's ability to conduct daily activities. FoG has been described as feeling like one's feet are glued or stuck to the floor. Drug treatments for PD rarely improve FoG. Researchers have found that vibration therapy may help improve FoG. The purpose of this research study is to test the safety, tolerability, and effectiveness of using a wearable device (UG motion sensor, that is the size of a watch) that will recognize FoG and then send a signal to another small watch-like device (PDVibe3) to deliver a vibration stimuli to participant's feet. The researchers believe the vibration stimulus (which feels like a phone on vibration mode) will help reduce FoG in persons with PD. The study is open to people who have been diagnosed with Parkinson's disease, have FoG, and meet the study entry requirements.

The PDVibe3 is an investigational device, which means it has not been approved by the U.S. Food and Drug Administration (FDA). The UG motion sensor is also an investigational device.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.