The Effect of Compensation Strategies on Gait Impairment in Parkinson's Disease (UNITE-PD)

July 22, 2025 updated by: Radboud University Medical Center

Unravelling the Neural Mechanisms Underlying Compensation Strategies for Gait Impairments in Parkinson's Disease: a Transnational, Multimodal Approach

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. Furthermore, it is still unknown how the efficacy of compensation strategies changes longitudinally. The goal of the UNITE-PD project is to address these questions. The investigators 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, the investigators 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, the investigators will define responders and non-responders to external and/or internal cueing. With the use of extensive clinimetrics, the aim is 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), the long-term effect of cueing in the responders can be investigated.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

384

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Responders
Device: Cueing app

All participants that are included come to the movement lab for the baseline measurement. The baseline measurement consists out of extensive clinimetrics (for example MDS-UPDRS) to identify patient characteristics. With the use of an objective gait assessment, the effectiveness of both internal and external cueing is determined. This will divide the participants in three groups; responders, non-responders and in between. Participants who clearly respond to either internal or external cueing (determined as the responders) are asked to apply the working form of cueing in daily life during the six-month follow-up. During this period the participants will use a mobile application that can provide them with a rhythmic auditory stimulus and records the use of this application.

After 6 months, both the responders and non-responders are asked to return to the lab for the follow up measurement in which the baseline measurement is repeated to evaluate the effect of long-term cueing.
No Intervention: Non-responders

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait Variability
Time Frame: Six months
Gait variability defined as the coefficient of variation of stride time. We will compare gait variability between the baseline condition, and the cueing conditions.
Six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait speed
Time Frame: Six months
Gait speed defined in meters per second
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

KU Leuven
Tel-Aviv Sourasky Medical Center
Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 16, 2023

First Submitted That Met QC Criteria

November 16, 2023

First Posted (Actual)

November 21, 2023

Study Record Updates

Last Update Posted (Actual)

July 25, 2025

Last Update Submitted That Met QC Criteria

July 22, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 113692

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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