Postural Training for Parkinson's Disease

(SegwayPD Trial)

Overseen By Subaryani Soedirdjo, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Neurological disorders, Major unstable illnesses, Sensory disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 week

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that you have been stable on your medication for at least 1 month before participating.

Is postural training for Parkinson's disease safe for humans?

Research shows that sensory feedback devices, like virtual sensory feedback and Equistasi, used for postural training in Parkinson's disease are generally safe and well-tolerated, with no reported side effects. ^{1 2 3 4 5}

How is Sensory-Augmented Postural Training different from other treatments for Parkinson's disease?

Sensory-Augmented Postural Training is unique because it uses enhanced sensory feedback, such as visual or virtual reality elements, to improve balance and postural control in Parkinson's patients, which is different from traditional balance training methods. ^{2 6 7 8 9}

What data supports the effectiveness of the treatment Sensory-Augmented Postural Training for Parkinson's Disease?

Research shows that balance training with augmented visual feedback and multimodal sensory feedback can improve postural control and gait in Parkinson's patients, suggesting that Sensory-Augmented Postural Training may also be effective. ^{2 3 5 6 10}

Who Is on the Research Team?

Yasin Dhaher, Ph.D.

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals aged 50-85 with idiopathic Parkinson's Disease at a moderate stage (Hoehn and Yahr stage III), who can stand and walk unaided for 5 minutes, whether on or off medication. They must have been stable on their current medication for at least one month.

Inclusion Criteria

I can stand and walk by myself for 5 minutes, with or without medication.

I have Parkinson's disease at stage III, affecting my balance.

I am between 50 and 85 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline Assessment

Participants undergo baseline assessments including postural sway, gait spatiotemporal parameters, and EEG spectral ratio

1 week

2 assessments (in-person)

Treatment

Participants receive 1-week postural training using Segway to provide augmented proprioceptive and visuospatial information

1 week

Multiple sessions (in-person)

Post-Treatment Assessment

Participants are assessed for changes in postural sway, gait spatiotemporal parameters, and EEG spectral ratio

1 week

1 assessment (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Sensory-Augmented Postural Training

Trial Overview The study tests the safety and effectiveness of sensory-augmented postural training using a Segway to improve balance in Parkinson's patients by providing continuous proprioceptive (body position sense) and visuospatial (space around us) feedback during exercises.

How Is the Trial Designed?

Group I: PD - individuals with Parkinson Disease, either male or female Experimental Treatment 1 Intervention

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)

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Published Research Related to This Trial

Perturbation-based balance training (PBT) shows promise in improving postural control and gait in people with Parkinson's disease, potentially reducing falls and the severity of symptoms, based on a systematic review of 11 studies.

Despite the positive findings, the overall quality of evidence was downgraded due to publication bias and methodological limitations, suggesting that further high-quality research is needed to confirm these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review on the effectiveness of perturbation-based balance training in postural control and gait in Parkinson's disease. Coelho, DB., de Oliveira, CEN., Guimarães, MVC., et al.[2022]

A pilot study involving 33 patients with Parkinson's disease showed that a balance training program using augmented visual feedback (VFT) was feasible and safe, with no adverse events reported during the five-week training.

While VFT showed favorable trends in improving balance measures compared to conventional training, it did not demonstrate statistically significant superiority in the primary outcome, the Functional Reach test, indicating that further optimization may be needed to enhance its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of augmented visual feedback during balance training in Parkinson's disease: a pilot randomized clinical trial. van den Heuvel, MR., Kwakkel, G., Beek, PJ., et al.[2014]

A pilot study involving 18 participants with Parkinson's disease showed that using real-time multimodal sensory feedback (MMSF) during stepping exercises significantly improved backward stride length over 12 and 18 weeks, suggesting enhanced gait safety and reduced fall risk.

Participants using MMSF reported greater self-perceived improvements in gait and quality of life, indicating that MMSF not only aids in physical performance but also positively impacts daily living and overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of real-time multimodal sensory feedback home program improved backward stride and retention for people with Parkinson Disease: A pilot study. Winkler, P., DeMarch, E., Campbell, H., et al.[2022]

Equistasi®, a wearable device that provides proprioceptive stimulation, has shown benefits in improving gait and postural stability in patients with Parkinson's Disease, based on a review of five studies.

The device appears to be safe and well-tolerated, but more high-quality research with long-term follow-ups is needed to fully understand its long-term effects on patients with Parkinson's Disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proprioceptive Focal Stimulation (Equistasi®) for gait and postural balance rehabilitation in patients with Parkinson's disease: A systematic review. Alashram, AR., Annino, G., Romagnoli, C., et al.[2023]

In a study involving 39 participants (13 moderately affected PD patients, 13 severely affected PD patients, and 13 healthy controls), advanced Parkinson's disease patients exhibited larger postural reactions to mechanical vibrations applied to the neck, indicating a disturbance in their postural control mechanisms.

The findings suggest that the issues with postural stability in advanced PD are not due to sensory deficits or central processing problems, but rather a failure to properly scale and adapt to proprioceptive information, implicating nondopaminergic brain structures in this impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postural reactions to neck vibration in Parkinson's disease. Valkovic, P., Krafczyk, S., Saling, M., et al.[2008]

A wearable virtual reality device that mimics natural sensory-motor feedback has shown significant improvements in gait for patients with Parkinson's disease, effectively eliminating freezing episodes without side effects.

The device also benefited patients with other movement disorders, such as multiple sclerosis and cerebral palsy, leading to substantial improvements in balance and gait, with lasting effects after training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual sensory feedback for gait improvement in neurological patients. Baram, Y.[2021]

A pilot study involving 40 patients with Parkinson's Disease (PD) showed that using a wearable proprioceptive stabilizer (Equistasi) during a 2-month balance training program led to significant improvements in balance and quality of life measures compared to those using an inactive device.

Patients using the Equistasi device experienced a notable reduction in fall rates and sustained improvements in balance assessments, indicating that the combination of balance training and focal mechanical vibrations may enhance rehabilitation outcomes for individuals with PD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A wearable proprioceptive stabilizer (Equistasi®) for rehabilitation of postural instability in Parkinson's disease: a phase II randomized double-blind, double-dummy, controlled study. Volpe, D., Giantin, MG., Fasano, A.[2018]

A study involving 42 people with Parkinson's disease showed that both virtual reality (VR) and conventional balance training (CB) improved postural control, particularly in challenging sensory conditions, after a 6-week training program.

While the VR group had significant improvements in balance under conditions of unreliable vision and somatosensation compared to a control group, there were no notable differences in overall balance scores or attentional demands between the VR and CB groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of virtual reality-augmented balance training on sensory organization and attentional demand for postural control in people with Parkinson disease: a randomized controlled trial. Yen, CY., Lin, KH., Hu, MH., et al.[2022]

Focal vibration training (FVT) significantly reduced the rate of falls in Parkinson's disease patients, decreasing from 2.1 to 1.25 falls per patient after eight weeks, indicating its efficacy in improving postural stability.

Patients who continued with FVT alongside a rehabilitative protocol maintained their medication dosage while experiencing fewer falls, whereas those who only received rehabilitation had to increase their medication, suggesting FVT may enhance rehabilitation outcomes without increasing medication needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focal Vibration Training (Equistasi®) to Improve Posture Stability. A Retrospective Study in Parkinson's Disease. Serio, F., Minosa, C., De Luca, M., et al.[2020]

A study involving 24 Parkinson's patients showed that sensorimotor integration training combined with conventional physiotherapy significantly improved postural control compared to conventional physiotherapy alone.

The improvements in balance were measured using computerized dynamic posturography and were maintained for 12 weeks, indicating the training's effectiveness in enhancing sensory processes related to balance in Parkinson's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensorimotor integration training in Parkinson`s disease. Fil-Balkan, A., Salci, Y., Keklicek, H., et al.[2021]

Citations

1. England pubmed.ncbi.nlm.nih.gov

A systematic review on the effectiveness of perturbation-based balance training in postural control and gait in Parkinson's disease. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Effects of augmented visual feedback during balance training in Parkinson's disease: a pilot randomized clinical trial. [2014]

3. England pubmed.ncbi.nlm.nih.gov

Use of real-time multimodal sensory feedback home program improved backward stride and retention for people with Parkinson Disease: A pilot study. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Proprioceptive Focal Stimulation (Equistasi®) for gait and postural balance rehabilitation in patients with Parkinson's disease: A systematic review. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Postural reactions to neck vibration in Parkinson's disease. [2008]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Virtual sensory feedback for gait improvement in neurological patients. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

A wearable proprioceptive stabilizer (Equistasi®) for rehabilitation of postural instability in Parkinson's disease: a phase II randomized double-blind, double-dummy, controlled study. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of virtual reality-augmented balance training on sensory organization and attentional demand for postural control in people with Parkinson disease: a randomized controlled trial. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Focal Vibration Training (Equistasi®) to Improve Posture Stability. A Retrospective Study in Parkinson's Disease. [2020]

10. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Sensorimotor integration training in Parkinson`s disease. [2021]