Freezing of GaitTACKLING-FOGNCT06302309
Tackling Anxiety-related Freezing of Gait in People With Parkinson's Disease
A study testing Psychological intervention in people with Freezing of Gait, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The purpose of this study is to investigate whether personalized strategies that target anxiety and stress surrounding freezing of gait can alleviate freezing of gait in people with Parkinson's Disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Freezing of Gait
- What is being tested?
- Psychological intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Apr 2024to 29 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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/women of age > 18 years with idiopathic Parkinson's disease, as diagnosed by the UK Brain Bank Criteria;
- Presence of daily FOG (as objectified with the new-freezing of gait questionnaire), that is related to anxiety (positive answer to the question: Does FOG occur -or get worse when you are anxious or stressed?);
- Using a stable dose of PD medication and stability of DBS settings (if applicable) during the trial. Adjustments of PD medication and DBS settings during the trial are allowed if deemed clinically necessary.
- Written informed consent.
Who cannot join
- Any comorbidity (i.e. neurological, orthopedic) that significantly impacts gait.
- Severe cognitive impairment hampering the ability to comply to the study protocol.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Department of Rehabilitation Radboudumc
Nijmegen, Gelderland, 6525GA
About this study
Official title: 'Managing the Mental State' to Tackle Anxiety-related Freezing of Gait in People With Parkinson's Disease: a Randomized Controlled Intervention Trial
The purpose of this study is to investigate whether personalized strategies that target anxiety and stress surrounding freezing of gait can alleviate freezing of gait in people with Parkinson's Disease.
Read the detailed description
Rationale:
Freezing of Gait (FOG) is a common and disabling symptom in people with Parkinson's Disease (PD), characterized by paroxysmal episodes where there is an inability to step effectively, despite attempting to do so. Treatment consists of complementary pharmacological and non-pharmacological treatment options which unfortunately only partially alleviate FOG. Anxiety has been found to contribute to the occurrence and exacerbation of FOG, which often manifests itself in situations where people with FOG anticipate not being in control of their movements. People with FOG are often aware of the feelings and situations that elicit FOG episodes, but they rarely actively employ strategies targeting their mental state to improve FOG. With the exception of general interventions including mindfulness, yoga and meditation, tailored strategies to ameliorate anxiety-related FOG have never been evaluated in a systematic manner.
Objective:
In this project we aim to evaluate whether a non-pharmacological and tailored intervention targeting anxiety- and stress-related FOG in people with PD is effective to reduce the impact of anxiety and stress on FOG. Specifically, we aim to study: (1) the effect of four sessions of a 'managing the mental state' intervention in people with disabling and anxiety-related FOG; and (2) the key determinants of the effectiveness of the intervention to reduce the impact of anxiety and stress on FOG.
Study design:
This study is a randomized controlled trial (RCT). The intervention group will receive the intervention immediately after randomization while a (waitlist) control group receives the same intervention thereafter.
Study population:
Forty people with PD that experience daily FOG (as objectified with the new-freezing of gait questionnaire) will be included, that is related to anxiety (positive answer to the question: Does FOG occur or get worse when you are anxious or stressed?).
Intervention:
The intervention consists of four sessions of a 'managing the mental state' intervention, of which the first and second session will take place in the home-setting of the patient; the two remaining sessions will take place remotely. The sessions include psychoeducation on what anxiety is and how stress and anxiety can influence FOG, identifying how people are allocating attention and engage in specific thought-processes (e.g. worrisome thoughts) during walking, and educating patients about 'managing the mental state' compensation strategies that involve ways to reduce anxiety or stress and will be specifically tailored to the individual patient.
Main study parameters/endpoints:
The primary outcome involves the percentage of time frozen during a home-based gait trajectory with self-selected FOG 'hotspots'. Secondary outcomes involve the subjective impact of anxiety and stress on FOG, as measured with a Visual Analogue Scale and the perceived levels of anxiety.
- Conditions
- Freezing of Gait
- Being tested
- Psychological intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological interventionOther
The intervention consists of four sessions of a 'managing the mental state' intervention, of which the first and second session will take place in the home-setting of the patient; the two remaining sessions will take place remotely. The sessions include psychoeducation on what anxiety is and how stress and anxiety can influence FOG, identifying how people are allocating attention and engage in specific thought-processes (e.g. worrisome thoughts) during walking, and educating patients about 'managing the mental state' compensation strategies that involve ways to reduce anxiety or stress and will be specifically tailored to the individual patient.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group will receive 4 sessions of the 'managing the mental state' intervention immediately after randomization. Receives: Other: Psychological intervention |
| Waitlist | Experimental | The control group will enter a waiting period of 4 weeks and receive the same 4-week intervention thereafter. Receives: Other: Psychological intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
% time frozen during a personalized gait trajectory
The primary outcome measure involves the percentage of time frozen during a personalized walking trajectory that includes self-selected FOG 'hotspots' in the home setting. This gait trajectory will be exactly the same during the baseline and consecutive measurements, and will be performed at comfortable gait speed. The gait trajectory will be video-taped by the assessor and performed three times during each visit.
Measured: Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline)
Secondary outcomes (9)
subjective impact of anxiety and stress on FOG, as measured with a Visual Analogue Scale
subjective impact of anxiety and stress on FOG, as measured with a Visual Analogue Scale
Measured: Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline)
Heart Rate Variability
Heart rate variability (HRV) will be measured to determine whether the gait measures induce physiological stress and to examine if the intervention leads to a reduction in physiological stress. For this purpose, we will collect 3-lead electrocardiogram signals for heart rate monitoring prior to and during the gait measures
Measured: Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline)
The Parkinson Anxiety Scale (PAS)
The Parkinson Anxiety Scale (PAS) [9] is a questionnaire that has been specifically developed for measuring anxiety in people with PD.
Measured: Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline)
Gait-Specific Attention Profile
The Gait-specific attentional profile (G-SAP) provides measurements of multiple psychological factors that influence gait performance. The G-SAP will be administered in order to determine whether psychological factors that are implicated in gait performance (e.g., conscious processing of movement, fall-related ruminations) are changed in response to the intervention
Measured: Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline)
he Updated Perceived Control over Falling Scale (UP-COF)
The Updated Perceived Control over Falling Scale (UP-COF) is a 4-item scale that will be administered to assess whether the intervention improves participants' perceived control over the risk of falling.
Measured: Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline)
New Freezing of Gait Questionnaire
The New-Freezing of Gait Questionnaire (N-FOGQ) assesses the subjective severity of Freezing of Gait.
Measured: Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline)
The Parkinson's Disease Questionnaire
The Parkinson's Disease Questionnaire (PDQ-39) will be administered to measure quality of life.
Measured: Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline)
The Rosenberg self-esteem score
The Rosenberg self-esteem score will be administered in order to assess self-esteem.
Measured: Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline)
Perceived Stress Scale
The Perceived Stress Scale will be administered in order to determine whether the intervention leads to a decrease in perceived levels of stress.
Measured: Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start4 Apr 2024
- Primary completion29 Dec 2025
- Study completion29 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Freezing of GaitStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jorik Nonnekes, PhD, Principal investigator, Radboud University Medical Center (Radboudumc)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302309
- Sponsor's protocol ID
- NL85217.091.23
- Acronym
- TACKLING-FOG
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vissers G, Tosserams A, Duits AA, van der Heide A, Bloem BR, Helmich RC, Young WR, Nonnekes J. Tackling Anxiety- and Stress-Related Freezing of Gait in People With Parkinson's Disease (TACKLING-FOG): Study Protocol for a Randomized Controlled Trial. Eur J Neurosci. 2026 Jun;63(12):e70584. doi: 10.1111/ejn.70584.
PubMed 42310830
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'Managing the Mental State' to Tackle Anxiety-related Freezing of Gait in People With Parkinson's Disease: a Randomized Controlled Intervention Trial
- ClinicalTrials.gov ID
- NCT06302309
- Acronym / sponsor ID
- TACKLING-FOG / NL85217.091.23
- Conditions
- Freezing of Gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 29 Dec 2025 (actual)
- Study completion
- 29 Dec 2025 (actual)
- First posted
- 8 Mar 2024 (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.
The purpose of this study is to investigate whether personalized strategies that target anxiety and stress surrounding freezing of gait can alleviate freezing of gait in people with Parkinson's Disease.
Detailed description
Rationale:
Freezing of Gait (FOG) is a common and disabling symptom in people with Parkinson's Disease (PD), characterized by paroxysmal episodes where there is an inability to step effectively, despite attempting to do so. Treatment consists of complementary pharmacological and non-pharmacological treatment options which unfortunately only partially alleviate FOG. Anxiety has been found to contribute to the occurrence and exacerbation of FOG, which often manifests itself in situations where people with FOG anticipate not being in control of their movements. People with FOG are often aware of the feelings and situations that elicit FOG episodes, but they rarely actively employ strategies targeting their mental state to improve FOG. With the exception of general interventions including mindfulness, yoga and meditation, tailored strategies to ameliorate anxiety-related FOG have never been evaluated in a systematic manner.
Objective:
In this project we aim to evaluate whether a non-pharmacological and tailored intervention targeting anxiety- and stress-related FOG in people with PD is effective to reduce the impact of anxiety and stress on FOG. Specifically, we aim to study: (1) the effect of four sessions of a 'managing the mental state' intervention in people with disabling and anxiety-related FOG; and (2) the key determinants of the effectiveness of the intervention to reduce the impact of anxiety and stress on FOG.
Study design:
This study is a randomized controlled trial (RCT). The intervention group will receive the intervention immediately after randomization while a (waitlist) control group receives the same intervention thereafter.
Study population:
Forty people with PD that experience daily FOG (as objectified with the new-freezing of gait questionnaire) will be included, that is related to anxiety (positive answer to the question: Does FOG occur or get worse when you are anxious or stressed?).
Intervention:
The intervention consists of four sessions of a 'managing the mental state' intervention, of which the first and second session will take place in the home-setting of the patient; the two remaining sessions will take place remotely. The sessions include psychoeducation on what anxiety is and how stress and anxiety can influence FOG, identifying how people are allocating attention and engage in specific thought-processes (e.g. worrisome thoughts) during walking, and educating patients about 'managing the mental state' compensation strategies that involve ways to reduce anxiety or stress and will be specifically tailored to the individual patient.
Main study parameters/endpoints:
The primary outcome involves the percentage of time frozen during a home-based gait trajectory with self-selected FOG 'hotspots'. Secondary outcomes involve the subjective impact of anxiety and stress on FOG, as measured with a Visual Analogue Scale and the perceived levels of anxiety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Psychological interventionThe intervention group will receive 4 sessions of the 'managing the mental state' intervention immediately after randomization. |
| Waitlist | Experimental | Other: Psychological interventionThe control group will enter a waiting period of 4 weeks and receive the same 4-week intervention thereafter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men/women of age > 18 years with idiopathic Parkinson's disease, as diagnosed by the UK Brain Bank Criteria;
- Presence of daily FOG (as objectified with the new-freezing of gait questionnaire), that is related to anxiety (positive answer to the question: Does FOG occur -or get worse when you are anxious or stressed?);
- Using a stable dose of PD medication and stability of DBS settings (if applicable) during the trial. Adjustments of PD medication and DBS settings during the trial are allowed if deemed clinically necessary.
- Written informed consent.
Key exclusion criteria (2 listed)
- Any comorbidity (i.e. neurological, orthopedic) that significantly impacts gait.
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 |
|---|---|---|
| Psychological interventionThe intervention consists of four sessions of a 'managing the mental state' intervention, of which the first and second session will take place in the home-setting of the patient; the two remaining sessions will take place remotely. The sessions include psychoeducation on what anxiety is and how stress and anxiety can influence FOG, identifying how people are allocating attention and engage in specific thought-processes (e.g. worrisome thoughts) during walking, and educating patients about 'managing the mental state' compensation strategies that involve ways to reduce anxiety or stress and will be specifically tailored to the individual patient. | Other | Intervention, Waitlist |
Primary outcome
% time frozen during a personalized gait trajectory
Time frame: Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline)
The primary outcome measure involves the percentage of time frozen during a personalized walking trajectory that includes self-selected FOG 'hotspots' in the home setting. This gait trajectory will be exactly the same during the baseline and consecutive measurements, and will be performed at comfortable gait speed. The gait trajectory will be video-taped by the assessor and performed three times during each visit.
9 secondary outcomes
subjective impact of anxiety and stress on FOG, as measured with a Visual Analogue Scale
Time frame: Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline)
Heart Rate Variability
Time frame: Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline)
The Parkinson Anxiety Scale (PAS)
Time frame: Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline)
Gait-Specific Attention Profile
Time frame: Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline)
he Updated Perceived Control over Falling Scale (UP-COF)
Time frame: Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline)
New Freezing of Gait Questionnaire
Time frame: Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline)
The Parkinson's Disease Questionnaire
Time frame: Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline)
The Rosenberg self-esteem score
Time frame: Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline)
Perceived Stress Scale
Time frame: Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Derived from this study: PubMed 42310830Vissers G, Tosserams A, Duits AA, van der Heide A, Bloem BR, Helmich RC, Young WR, Nonnekes J. Tackling Anxiety- and Stress-Related Freezing of Gait in People With Parkinson's Disease (TACKLING-FOG): Study Protocol for a Randomized Controlled Trial. Eur J Neurosci. 2026 Jun;63(12):e70584. doi: 10.1111/ejn.70584.
- Individual participant dataSharing planned: No
Related trials for Freezing of Gait
Recruiting
Decoding the Neural Mechanisms Underlying Postural Instability and Gait Dysfunction in Parkinson's Disease
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Function-based Accelerated Stimulation Therapy (FAST-therapy) for Freezing of Gait (FOG) After Parkinson's Disease (PD)
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Active, not recruitingPhase 2
Spinal Cord Stimulation for Freezing of Gait in Parkinson's Disease
Freezing of Gait, Parkinson Disease
RecruitingObservational study
Visuomotor Control in Parkinson Disease
Parkinson Disease
Recruiting
Correlation of STN-DBS Induced Visuospatial Changes and Freezing of Gait
Parkinson Disease, Gait Disorders, Neurologic
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. This study is not recruiting at the moment.
Jorik Nonnekes, PhD principal investigator
Radboud University Medical Center (Radboudumc)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological intervention in people with Freezing of Gait, 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 12 Mar 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% time frozen during a personalized gait trajectory (time frame: Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06302309, which also lists 1 linked publication.
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 12 Mar 2026.