Image

The Effect of Compensation Strategies on Gait Impairment in Parkinson's Disease

Recruiting
18 years of age
Both
Phase N/A

Powered by AI

Overview

Gait disturbances are disabling and common in Parkinson's disease (PD). Patients use many different, and typically self-developed, strategies to compensate for their walking abnormalities. There is a wide variety of compensatory strategies, of which external and internal cueing are the most commonly known. External cueing refers to externally produced predictive stimuli such as a metronome, whereas internal cueing refers to a movement reference generated internally, such as counting while walking. The efficacy of external and internal cueing varies dramatically across patients, and some patients can even be identified as 'non-responders' to a particular cue. Consequently, a one-size-fits-all approach simply does not suffice, which increases the need for better understanding of the key mechanisms behind these compensation strategies. Additionally, it is still unknown how the efficacy of compensation strategies changes longitudinally. The goal of this project is to address these questions. We aim to investigate whether the efficacy of internal and external cueing changes over time, and whether it is differentially affected in responders and non-responders. In order to work towards a more personalized treatment for patients with PD, we also aim to identify potential patient characteristics that can mediate the actual use of compensation strategies in daily life.

The multicenter UNITE-PD project is divided in a joint package and individual site-specific packages. All partners will investigate the neural working mechanisms of compensation strategies in PD from different angles in the site-specific packages. The joint package focusses on the long-term effect of the compensation strategies and the potential patient characteristics that can influence the efficacy of the compensation strategies. In this project we define responders and non-responders to external and/or internal cueing. With the use of extensive clinimetrics we aim to identify patient characteristics that might influence the efficacy. With the use of a custom made cueing app (which will be applied during a follow up period of six months), we investigate the long-term effect of cueing in the responders.

Together, all centers aim to include a total of 384 participants (Netherlands N = 104, Belgium N =90, Israel N = 75, Italy N = 115). Importantly, this sample size is not based on the joint workpackage described here, but on the numbers needed for the individual site-specific work packages.

Eligibility

Inclusion Criteria:

  • Men and women of age > 18 years with idiopathic Parkinson's disease;
  • Written informed consent.

Exclusion Criteria:

  • Daily usage of compensation strategies for the past month;
  • Presence of deep brain stimulation (DBS);
  • Presence of severe co-morbidity limiting ambulation (e.g. stroke, orthopaedic problems);
  • Inability to walk unaided (with the exception of a customary cane);
  • Inability to walk for > 3 minutes consecutively;
  • Severe auditory impairments, hampering perception of auditory cues;
  • Severe cognitive impairment (MMSE < 21)

Study details

Parkinson Disease

NCT06142448

Radboud University Medical Center

26 January 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.