Tactile Cueing for Parkinson's Disease

(cueing Trial)

Overseen By Graham Harker, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Must not be taking: Dopamine-blocking, Cholinesterase inhibitors

Disqualifiers: Severe dyskinesia, Dementia, Others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how a new tactile cueing system can help people with Parkinson's Disease (PD) improve their walking. Participants will test two types of cueing: one that adjusts to each step (personalized tactile cueing) and another that uses a steady rhythm (fixed tactile cueing). The goal is to determine if these cues can make walking feel more automatic and less mentally taxing. This study may suit those diagnosed with Parkinson's who experience issues like tremors or balance problems but do not have other conditions affecting their walking. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance daily life for those with Parkinson's.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using dopamine-blocking agents or cholinesterase inhibitors.

What prior data suggests that this tactile cueing system is safe for people with Parkinson's Disease?

Research shows that touch-based cues, both personalized and fixed, are generally safe for people with Parkinson's Disease. Earlier studies have demonstrated that personalized touch cues, such as vibrations matching a person's steps, offer potential benefits without major safety issues. These cues aim to improve walking by providing real-time feedback through vibrations.

For fixed touch cues, studies indicate they are well-tolerated. A review found that this method could enhance walking speed and step length in Parkinson's patients during dual-task activities, without significant side effects. Another study on a similar device called CUE1 found it safe and easy to use, suggesting it might be a promising non-invasive treatment option.

Both methods enhance the brain's understanding of the body's position and movement. Overall, evidence suggests these touch-based cues are safe and may help improve walking in people with Parkinson's. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these tactile cueing methods for Parkinson's disease because they offer innovative ways to enhance movement. Unlike traditional treatments that mainly focus on medication to manage symptoms, these methods use tactile feedback to improve gait. Personalized cueing adapts in real-time to a person's walking pattern, providing synchronized feedback that could lead to more natural movement. On the other hand, fixed cueing provides consistent rhythmic feedback, which might help some patients maintain a stable walking rhythm. Both approaches could offer new, non-pharmacological options to help patients regain better control over their movements.

What evidence suggests that this trial's tactile cueing treatments could be effective for Parkinson's Disease?

This trial will compare two types of tactile cueing for Parkinson's disease: personalized and fixed. Research has shown that touch-based signals can improve movement in people with Parkinson's disease. For personalized touch signals, which participants in this trial may receive, studies suggest they might reduce activity in the prefrontal cortex, potentially making walking feel more natural. They also seem to enhance the smoothness and speed of walking. For fixed touch signals, another treatment option in this trial, the evidence is not as strong, but some research suggests they might help increase walking speed and step length in certain situations. Overall, devices using touch signals show promise in improving movement for Parkinson's patients. ^{1 2 3 6 7}

Who Is on the Research Team?

Martina Mancini, PhD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for people with Parkinson's Disease who can walk and follow instructions. They must be diagnosed by a specialist, not have other serious nervous system issues besides PD, and be at specific stages of the disease where symptoms are moderate.

Inclusion Criteria

I don't have any nerve or muscle disorders affecting my balance or walking, other than Parkinson's disease.

I can follow study instructions and agree to participate.

My Parkinson's disease is at a moderate stage.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into one of two cueing interventions: personalized, step-synchronized tactile cueing or tactile cueing at fixed intervals.

1 week

Daily monitoring

Follow-up

Participants are monitored for retention of gait and turning improvements with a third week of continuous monitoring.

1 week

Continuous monitoring

Extension

Exploration of the feasibility and potential benefits of independent use of tactile cueing during a week in daily life.

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Fixed tactile cueing
• Personalized tactile cueing

Trial Overview The study tests two types of tactile cueing systems to see if they help improve walking by making it more automatic and less reliant on thinking. One group gets cues synced with their steps; the other gets regular timed cues.

How Is the Trial Designed?

Group I: Personalized cueing Experimental Treatment 1 Intervention

Personalized, step-synchronized tactile cueing, enhancing proprioceptive inputs, in the form of real-time, closed-loop tactile feedback signaling left and right stance times while walking

Group II: Fixed cueing Active Control 1 Intervention

Tactile cueing at fixed intervals, enhancing proprioceptive inputs, in the form of open-loop tactile feedback (fixed rhythm) signaling left and right stance times while walking

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

In a 6-week rehabilitation study involving 20 patients with idiopathic Parkinson's disease, the use of external sensory cues during therapy led to sustained improvements in motor function compared to those who did not receive cues.

While both groups showed initial improvements in their UPDRS scores, the 'cued' group maintained significant benefits at follow-up, suggesting that sensory cues may help patients learn new motor strategies that compensate for their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of sensory cues in the rehabilitation of parkinsonian patients: a comparison of two physical therapy protocols. Marchese, R., Diverio, M., Zucchi, F., et al.[2022]

A novel cueing strategy using realistic 'action-related' sounds, like footsteps on gravel, helps Parkinson's disease (PD) patients improve their step length and reduce variability in their gait, showing that auditory cues can effectively convey spatial and temporal information.

Healthy individuals could adapt their step length to various auditory cues, but PD patients only showed significant improvements when walking to or imagining the recorded sounds, suggesting they may require more specific sensory information to trigger motor responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auditory observation of stepping actions can cue both spatial and temporal components of gait in Parkinson׳s disease patients. Young, WR., Rodger, MW., Craig, CM.[2022]

In a study involving 31 individuals with Parkinson's disease, neither tactile cueing via vibrating socks nor auditory cueing significantly reduced the overall percentage of time frozen during gait tasks at the group level.

Despite the lack of group-level improvement, 22 out of 31 participants showed individual responses to cueing, indicating that personalized approaches may be necessary for effectively managing freezing of gait in Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Good vibrations: tactile cueing for freezing of gait in Parkinson's disease. Klaver, EC., van Vugt, JPP., Bloem, BR., et al.[2023]

A closed-loop cueing framework for gait training in people with Parkinson's showed promising results, allowing for individualized cue optimization and better retention of improved gait performance without cues.

This framework was found to be more efficient and robust compared to fixed cueing strategies, with similar effectiveness in changing cadence, indicating its potential as a superior method for gait rehabilitation in early-stage Parkinson's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptive cueing strategy for gait modification: A case study using auditory cues. Wu, TLY., Murphy, A., Chen, C., et al.[2023]

A systematic review of 24 studies involving 626 patients with Parkinson's disease found strong evidence that auditory rhythmical cueing can significantly improve walking speed.

However, the effectiveness of visual and tactile cueing was deemed insufficient, and there is uncertainty about whether improvements in walking speed translate to better daily activities or reduced falls in real-life situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of external rhythmical cueing on gait in patients with Parkinson's disease: a systematic review. Lim, I., van Wegen, E., de Goede, C., et al.[2022]

In a study of 43 adults with Parkinson's disease, closed-loop cueing (tactile feedback) improved trunk stability during the weight transfer phase of gait, suggesting it may enhance local dynamic stability.

Both open-loop and closed-loop cueing resulted in slower gait speed and shorter stride length, indicating that while cueing can help with stability, it may also affect overall walking performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase-Dependent Effects of Closed-Loop Tactile Feedback on Gait Stability in Parkinson's Disease. Fino, PC., Mancini, M.[2021]

In a study involving 19 Parkinson's patients, including those with and without freezing of gait, action-relevant auditory cues significantly reduced gait variability, suggesting they can effectively aid movement in these patients.

Combining action-relevance with acoustic continuity in auditory cues led to notable improvements in stepping, indicating that these cues may help engage the brain's motor pathways and bypass issues caused by Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auditory cueing in Parkinson's patients with freezing of gait. What matters most: Action-relevance or cue-continuity? Young, WR., Shreve, L., Quinn, EJ., et al.[2020]

Open- and closed-loop cueing significantly improved turning characteristics in people with Parkinson's disease, as evidenced by reduced freezing of gait and improved turning smoothness during a one-minute turning task with 25 subjects with freezing of gait and 18 without.

While both cueing methods enhanced turning smoothness, they also resulted in slower turning velocity and fewer turns compared to baseline, indicating a trade-off that needs further investigation for practical mobility improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the ability of open- and closed-loop cueing to improve turning and freezing in people with Parkinson's disease. Mancini, M., Smulders, K., Harker, G., et al.[2019]

The study found that using visual cues, specifically light stripes projected on the floor, significantly improved step length and step time in people with Parkinson's disease, indicating potential benefits for alleviating gait impairment and freezing of gait.

Participants reported positive experiences with both visual and auditory cues, with many expressing a desire for this technology in their homes, suggesting a strong user interest and potential for future development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development of a home-based technology to improve gait in people with Parkinson's disease: a feasibility study. Yogev-Seligmann, G., Josman, N., Bitterman, N., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05818189

Cortical Correlates of Gait in Parkinson's Disease: Impact ... The purpose of the study is to determine the effects of a novel, personalized, tactile cueing system on gait automaticity. The researchers hypothesized that ...

2. withpower.com withpower.com/trial/phase-parkinsonian-disorders-2024-ae69a

Tactile Cueing for Parkinson's Disease (cueing Trial) In a study involving 31 individuals with Parkinson's disease, neither tactile cueing via vibrating socks nor auditory cueing significantly reduced the overall ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39640985/

The effect of tactile cueing on dual task performance in ... Conclusion: The meta-analysis provides weak evidence that tactile cueing may enhance walking speed and step length in DT conditions in PD.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11617393/

The effect of tactile cueing on dual task performance in ... The meta-analysis provides weak evidence that tactile cueing may enhance walking speed and step length in DT conditions in PD.

5. binasss.sa.cr binasss.sa.cr/bibliotecas/bhm/feb24/13.pdf

The Efficacy of Wearable Cueing Devices on Gait and ... Abstract. Objective: To summarize the efficacy of wearable cueing devices for improving gait and motor function of patients with Parkinson disease (PWP).

6. medrxiv.org medrxiv.org/content/10.1101/2025.07.23.25332038v1.full.pdf

Usability, Safety and Tolerability of CUE1 Vibrotactile ... tasking), tandem stance, and reduced fatigue. 59. • The CUE1 was safe, well-tolerated, and shows potential as a non-invasive therapeutic.

7. researchgate.net researchgate.net/publication/385495131_Effect_of_Tactile_Cueing_on_Dual_Task_Performance_in_Parkinson's_Disease_A_Systematic_Review_and_Meta-Analysis

(PDF) Effect of Tactile Cueing on Dual Task Performance in ... Effect of Tactile Cueing on Dual Task Performance in Parkinson's Disease. A Systematic Review and Meta-Analysis. September 2024. Conference: ...