Recruiting NCT05982730

SegwayPD: The Effect of Sensory-augmented Postural Training Using Segway on Motor and Cognitive Function in Individuals With Parkinson's Disease

No phase Interventional Parkinson Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Sensory-Augmented Postural Training.
Who it may be relevant to: Registry conditions: Parkinson Disease. Basic parameters: 50 years — 85 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

Detailed description

The purpose of this study is to examine the safety and efficacy of postural training emphasized on the integration of multiple sensory information into motor control in individuals with PD (Parkinson's disease). This project is a proof-of-concept study to assess the effectiveness of postural training using Segway, which serves a platform to provide augmented and continuous proprioceptive and visuospatial information during postural training. Specifically, we will measure postural sway during quiet standing, single and dual-task walking performances, and brain activation during single and dual-task walking from the regions involved in planning and execution of locomotion; these include dorsolateral prefrontal cortex, premotor cortex and primary motor cortex. The changes in visuospatial function and proprioception after training will also be assessed. Individuals with moderate disease stage of PD exhibiting postural instability will be recruited. The participants will receive 1-week training and be assessed at 3 time points: 1-week before, before, and after the training.

Interventions

Behavioral Sensory-Augmented Postural Training
To examine the safety and efficacy of postural training emphasized on the integration of multiple sensory information into motor control and to assess the effectiveness of postural training using Segway

Primary outcome measures

Change from baseline postural sway at week 3 [Time frame: Week 1 (2 assessments), Week 3 (1assessment)]

Secondary outcome measures (3)

Feasibility of Segway training [Time frame: Week 3 (1 assessment)]
Change from baseline gait spatiotemporal parameters at week 3 [Time frame: Week 1 (2 assessments), Week 3 (1assessment)]
Change from baseline EEG spectral ratio at week 3 [Time frame: Week 1 (2 assessments), Week 3 (1assessment)]

Eligibility criteria

Inclusion criteria

a clinical diagnosis of idiopathic PD with moderate disease stage presenting balance alterations (Hoehn and Yahr stage III)
being stable on medication for at least 1 month
the ability to stand and walk unsupported for 5 min both on and off medication
age between 50 and 85

Exclusion criteria

neurological disorders other than PD
major unstable medical illnesses
sensory or musculoskeletal disorders (e.g., diabetes, uncorrected visual problems, arthritis, severe hearing impairments) that will prohibit the ability to perform the assessment tests and receive training

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Basic science

Study locations

United States · 1 center

University of Texas Southwestern Medical Center — Dallas

Identifiers

NCT: NCT05982730 · 46179; STU-2023-0066

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗