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

Trial Summary

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 data supports the effectiveness of tactile cueing treatment for Parkinson's Disease?

Research shows that both open-loop and closed-loop tactile cueing can improve turning and reduce freezing in people with Parkinson's Disease. Additionally, using external sensory cues in rehabilitation can extend the benefits of physical therapy, helping patients maintain improvements in daily activities and motor skills. ^{1 2 3 4 5}

Is tactile cueing safe for humans?

The studies on tactile cueing for Parkinson's disease suggest it is generally safe, as they focus on improving movement without reporting any significant safety concerns. ^{1 2 3 6 7}

How is tactile cueing treatment different from other treatments for Parkinson's disease?

Tactile cueing treatment for Parkinson's disease is unique because it uses touch-based signals to help improve walking patterns, unlike other treatments that often rely on visual or sound cues. This approach can be personalized to the individual's walking rhythm, potentially offering better efficiency and retention of improved gait patterns. ^{1 2 6 8 9}

What is the purpose of this trial?

The purpose of the study is to determine the effects of a novel, personalized, tactile cueing system on gait automaticity. The researchers hypothesized that step-synchronized tactile cueing will reduce prefrontal cortex activity (improve automaticity) and improve gait variability (as well as gait speed). The researchers predict that improved automaticity with improved gait variability will be associated with increased activation of other than prefrontal cortical areas while walking (i.e., sensory-motor). To determine the effects of cueing, 60 participants with PD from will be randomized into one, of two, cueing interventions: 1) personalized, step-synchronized tactile cueing and 2) tactile cueing at fixed intervals as an active control group. In addition, the researchers will explore the feasibility and potential benefits of independent use of tactile cueing during a week in daily life for a future clinical trial. This project will characterize the cortical correlates of gait automaticity, the changes in gait automaticity with cueing in people with Parkinson's Disease, and how these changes translate to improvement in gait and turning. The long-term goal is to unravel the mechanisms of impaired gait automaticity in Parkinson's Disease.

Research Team

Martina Mancini, PhD

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 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]

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]

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]

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]

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]

References

1. England 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. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Adaptive cueing strategy for gait modification: A case study using auditory cues. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Good vibrations: tactile cueing for freezing of gait in Parkinson's disease. [2023]

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

Effects of external rhythmical cueing on gait in patients with Parkinson's disease: a systematic review. [2022]

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

The role of sensory cues in the rehabilitation of parkinsonian patients: a comparison of two physical therapy protocols. [2022]

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

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

7. England pubmed.ncbi.nlm.nih.gov

The development of a home-based technology to improve gait in people with Parkinson's disease: a feasibility study. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Auditory cueing in Parkinson's patients with freezing of gait. What matters most: Action-relevance or cue-continuity? [2020]

9. England pubmed.ncbi.nlm.nih.gov

Auditory observation of stepping actions can cue both spatial and temporal components of gait in Parkinson׳s disease patients. [2022]