Investigating Therapies for Freezing of Gait
- Conditions
- Parkinson DiseaseGait Disorders, Neurologic
- Interventions
- Behavioral: Cognitive Behavioural TherapyBehavioral: Cognitive TrainingBehavioral: Proprioceptive Training
- Registration Number
- NCT03065127
- Lead Sponsor
- Sun Life Financial Movement Disorders Research and Rehabilitation Centre
- Brief Summary
Freezing of gait (FOG) is arguably one of the most debilitating motor symptoms experienced by individuals with Parkinson's disease (PD). FOG may be caused by an overload of cognitive, limbic, and sensorimotor system activity in the basal ganglia. Therefore, the purpose of this study is to evaluate cognitive, limbic, and sensorimotor therapies in individuals with FOG. Participants in this study will undergo all three types of treatments in a randomized counterbalanced order. Each treatment will occur in 1 hour sessions, twice weekly for a period of 4 weeks.
- Detailed Description
Freezing of gait (FOG) is arguably one of the most debilitating motor symptoms experienced by individuals with Parkinson's disease (PD), and negatively impacts quality of life (Walton et al., 2015). Furthermore, advanced FOG does not respond well to treatments commonly used in Parkinson's disease (Nutt et al., 2011), therefore warranting the use of adjunct treatment options. The development of potential treatment strategies for FOG should focus on the underlying mechanism. The cross-talk model of FOG proposes that FOG may be caused by an overload of cognitive, limbic, and sensorimotor system activity in the basal ganglia, resulting in a depletion of dopaminergic resources, leading to FOG (Lewis \& Barker, 2009). Hence, based on the cross-talk model, treatments targeting the cognitive, sensorimotor and limbic systems independently may lead to a reduction in FOG episodes. Previous studies have demonstrated the efficacy of therapies targeting these domains in PD and healthy individuals, however, these have yet to be explored in FOG. Therefore, the purpose of this study is to evaluate cognitive, sensorimotor, and limbic therapies in individuals with FOG.
This study will employ a within-subjects design, in which participants will undergo all three treatments in a randomized counterbalanced order. Sessions for each type of treatment will occur for 1 hour, twice weekly for a period of 4 weeks. Participants will also undergo pre- and post-test assessments prior to and following each 4-week treatment period. The cognitive training will utilize the "Smartbrain Pro" computer software, which has previously demonstrated efficacy in individuals with Parkinson's disease (Paris et al., 2011). The sensorimotor training group will participate in proprioceptive training of the upper and lower limbs. This training will entail a target matching task, in which participants will produce active and self-defined movements while blindfolded (i.e. without visual feedback). The limbic training group will undergo cognitive behavioural therapy (CBT) focusing solely on anxiety symptoms.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 17
- Either gender
- Diagnosed with idiopathic PD by a Neurologist
- Self-reported FOG with the use of UPDRS-II (Question 14)
- Confirmation of present FOG by a movement disorder specialist
- Able to walk 10 meters, unassisted
- Able to understand English instructions
- A neurological disease other than PD
- Peripheral neuropathy
- Clinically diagnosed with dementia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Cognitive Behavioural Therapy Cognitive Behavioural Therapy Participants will undergo one-on-one sessions of cognitive-behavioural therapy (CBT) working with a therapist to establish an individualized CBT plan which will focus on symptoms of anxiety. Participants will complete a total of eight one-hour sessions over 4 weeks. Cognitive Training Cognitive Training Participants will independently complete cognitive exercises on the "Smartbrain Pro" computer software. These exercises aim to train different aspects of executive function. The difficulty level of each exercise will increase relative to each participant's progress. Sessions will last for one hour, occurring twice weekly for a period of 4 weeks. Proprioceptive Training Proprioceptive Training Participants will complete one-on-one sessions a target matching proprioceptive training protocol using their upper and lower limbs. For the upper limb target-reaching task, participants will be seated in front of a surface marked with ten targets. They will first visualize a specified target, then blindfolded and asked to reach towards that target with the blindfold on. The blindfold will then be removed allowing participants to view their performance relative to the target. This task will be repeated for the remaining targets on both sides and for both upper and lower limbs. Participants will complete a total of eight one-hour sessions over 4 weeks.
- Primary Outcome Measures
Name Time Method Gait Assessment Change from Baseline at 4 weeks of third treatment phase Participants will walk approximately 9.75 metres for 12 trials. Recording of kinematic data will be done with eight Optotrak® cameras (Northern Digital, NDI, Waterloo, Ontario). Spatiotemporal gait parameters will be analyzed from this assessment.
- Secondary Outcome Measures
Name Time Method Passive Joint Angle Matching Pre-intervention and Post-intervention at week 4 of third treatment phase This task will be assessed in order to evaluate proprioceptive functioning.
Unified Parkinson's disease Rating Scale Motor Subsection (UPDRS-III) Pre-intervention and Post-intervention at week 4 of third treatment phase A clinician administered assessment which evaluates individuals' motor symptom severity
New Freezing of Gait Questionnaire (NFOGQ) Pre-intervention and Post-intervention at week 4 of third treatment phase Participants will be asked to complete the New Freezing of Gait Questionnaire (NFOGQ) questionnaire developed by Nieuwboer and colleagues (2009). This provides a self-reported measure of frequency and duration of FOG episodes. This tool has been validated and proven to be highly reliable in individuals with PD, as well as assessing treatment interventions for FOG.
Stroop Test Pre-intervention and Post-intervention at week 4 of third treatment phase This test assesses inhibitory control and will be administered in a paper-based format.
Trail-making test Pre-intervention and Post-intervention at week 4 of third treatment phase This will also be administered in a paper-based format. This test will assess visuospatial function and set-shifting ability.
Parkinson Anxiety Scale Pre-intervention and Post-intervention at week 4 of third treatment phase The Parkinson Anxiety Scale (PAS), which is a self-report questionnaire used to assess anxiety levels, will be administered to participants. This tool has demonstrated good concurrent validity in individuals with PD against other existing anxiety scales (Leentjens et al., 2014).
Trial Locations
- Locations (1)
Sun Life Financial Movement Disorders Research and Rehabilitation Centre
🇨🇦Waterloo, Ontario, Canada