NCT05982730

Brief Summary

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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
2mo left

Started Nov 2023

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Nov 2023Jul 2026

First Submitted

Initial submission to the registry

July 6, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 9, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

November 8, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

2.7 years

First QC Date

July 6, 2023

Last Update Submit

August 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change from baseline postural sway at week 3

    The midpoint between the tip of left and right calcaneus bones is considered as the origin of the reference system of the center of pressure (CoP). The CoP displacement along lateral and anterior-posterior axes are measured. The overall size of postural sways will be estimated from the ellipse area conveying 85% of the total CoP samples. The postural sway obtained from 2 assessments during week 1 will be averaged and used as baseline value. The postural sway obtained at week 3 is used to analyze the change from baseline due to training intervention (week 2).

    Week 1 (2 assessments), Week 3 (1assessment)

Secondary Outcomes (3)

  • Feasibility of Segway training

    Week 3 (1 assessment)

  • Change from baseline gait spatiotemporal parameters at week 3

    Week 1 (2 assessments), Week 3 (1assessment)

  • Change from baseline EEG spectral ratio at week 3

    Week 1 (2 assessments), Week 3 (1assessment)

Study Arms (1)

PD - individuals with Parkinson Disease, either male or female

EXPERIMENTAL

Individuals, aged 50-85, with a clinical diagnosis of idiopathic Parkinson Disease, either male or female, with moderate disease stage presenting balance alterations (Hoehn or Yahr stage III)

Behavioral: Sensory-Augmented Postural Training

Interventions

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

PD - individuals with Parkinson Disease, either male or female

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Yasin Dhaher, Ph.D.

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Chen Chung, PT, Ph.D.

CONTACT

Subaryani Soedirdjo, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

July 6, 2023

First Posted

August 9, 2023

Study Start

November 8, 2023

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

August 13, 2025

Record last verified: 2025-08

Locations