Parkinson DiseaseUNITE-PDNCT06142448
The Effect of Compensation Strategies on Gait Impairment in Parkinson's Disease
A study testing Cueing app in people with Parkinson Disease, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Cueing app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2023to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women of age > 18 years with idiopathic Parkinson's disease;
- Written informed consent.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Radboudumc
Nijmegen
Cindel Albers, cindel.albers@radboudumc.nl
About this study
Official title: 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.
- Conditions
- Parkinson Disease
- Being tested
- Cueing app
- Keywords
- Rehabilitation, Gait Impairment, Personalized treatment, Compensation strategies
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cueing appDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Responders | Experimental | Not described Receives: Device: Cueing app |
| Non-responders | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Variability
Gait variability defined as the coefficient of variation of stride time. We will compare gait variability between the baseline condition, and the cueing conditions.
Measured: Six months
Secondary outcomes (1)
Gait speed
Gait speed defined in meters per second
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start1 Dec 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven, Tel-Aviv Sourasky Medical Center, Fondazione IRCCS Policlinico San Matteo di Pavia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142448
- Sponsor's protocol ID
- 113692
- Acronym
- UNITE-PD
- Status last verified
- Mar 2025
- First submitted
- 16 Nov 2023
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unravelling the Neural Mechanisms Underlying Compensation Strategies for Gait Impairments in Parkinson's Disease: a Transnational, Multimodal Approach
- ClinicalTrials.gov ID
- NCT06142448
- Acronym / sponsor ID
- UNITE-PD / 113692
- Conditions
- Parkinson Disease
- Keywords
- Rehabilitation, Gait Impairment, Personalized treatment, Compensation strategies
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- KU Leuven, Tel-Aviv Sourasky Medical Center, Fondazione IRCCS Policlinico San Matteo di Pavia
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Responders | Experimental | Device: Cueing app |
| Non-responders | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women of age > 18 years with idiopathic Parkinson's disease;
- Written informed consent.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cueing appAll 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. | Device | Responders |
Primary outcome
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.
1 secondary outcome
Gait speed
Time frame: Six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cueing app in people with Parkinson Disease, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cindel Albers ((024) 366 84 26, cindel.albers@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Variability (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.