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

Parkinson Disease Clinical Trial

— SegwayPD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05982730
• Other study ID #: 46179
• Status: Recruiting
• Phase: N/A
• Start date: November 8, 2023
• Est. completion date: July 14, 2025

Study information

• Verified date: March 2024
• Source: University of Texas Southwestern Medical Center
• Contact: Yu-Chen Chung, PT, Ph.D.
• Phone: 214-648-8838
• Email: yu-chen.chung[@]utsouthwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: July 14, 2025
• Est. primary completion date: July 14, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Feasibility of Segway training	The attendance of training session for each participant will be used to assess the feasibility of the 1-week postural training. Adherence above 80% will indicate that the participants receive the training well.	Week 3 (1 assessment)
Secondary	Change from baseline gait spatiotemporal parameters at week 3	Spatiotemporal parameters will be used to characterized walking in dual task and single task conditions. One gait cycle will be defined as period from heel strike to the consecutive heel strike of the ipsilateral leg. The gait's spatiotemporal parameters obtained from 2 assessments during week 1 will be averaged and used as baseline value. The gait's spatiotemporal parameters 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	Change from baseline EEG spectral ratio at week 3	The absolute powers in delta (0.5-4 Hz), theta (4-8 Hz), alpha (8-13 Hz), and beta (13 - 30 Hz) frequency bands obtained using Fast Fourier Transform will be used to calculate the spectral ratio of the frequency bands. The spectral ratio is defined as ratio of the sum of absolute powers in the alpha and beta bands divided by the sum of the absolute power in the delta and theta frequency bands. The spectral ratio obtained from 2 assessments during week 1 will be averaged and used as baseline value. The spectral ratio 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)