Tackling Anxiety-related Freezing of Gait in People With Parkinson's Disease

NCT06302309 | Completed

• 1 other identifier: NL85217.091.23
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Freezing of Gait

Outcome Measures

Primary Outcomes (1)

• % 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.

  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

  Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline)

• Heart Rate Variability

  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)

  Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline)

• Gait-Specific Attention Profile

  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)

  Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline)

Other Outcomes (2)

• Montreal Cognitive Assessment

  Baseline

• Unified Parkinson's Disease Rating Scale Part III

  Baseline

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention group will receive 4 sessions of the 'managing the mental state' intervention immediately after randomization.

Other: Psychological intervention

Waitlist

EXPERIMENTAL

The control group will enter a waiting period of 4 weeks and receive the same 4-week intervention thereafter.

Other: Psychological intervention

Interventions

Psychological intervention OTHER

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.

Intervention; Waitlist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Any comorbidity (i.e. neurological, orthopedic) that significantly impacts gait.
• Severe cognitive impairment hampering the ability to comply to the study protocol.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Department of Rehabilitation Radboudumc

Nijmegen, Gelderland, 6525GA, Netherlands

Location

MeSH Terms

Interventions

Psychosocial Intervention

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jorik Nonnekes, PhD

  Radboud University Medical Center (Radboudumc)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Randomization will be performed in CastorEDC, a web-based data management system for academic studies (www.castoredc.com). Breaking of the randomization code is not applicable, since researchers and trainers cannot be blinded.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 8, 2024
• Study Start: April 4, 2024
• Primary Completion: December 29, 2025
• Study Completion: December 29, 2025
• Last Updated: March 12, 2026

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)