Clinical Trial: Investigating Therapies for Freezing of Gait
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Investigating Therapies for Freezing of Gait Targeting the Cognitive, Limbic, and Sensorimotor Domains
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 Summary:
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 pr
Sponsor: Sun Life Financial Movement Disorders Research and Rehabilitation Centre
Current Primary Outcome:
- Gait Assessment [ Time Frame: Change from Baseline at 4 weeks of first 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.
- Gait Assessment [ Time Frame: Change from Baseline at 4 weeks of second 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.
- Gait Assessment [ Time Frame: 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.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Stroop Test [ Time Frame: Pre-intervention and Post-intervention at week 4 of first treatment phase ]This test assesses inhibitory control and will be administered in a paper-based format.
- Trail-making test [ Time Frame: Pre-intervention and Post-intervention at week 4 of first treatment phase ]This will also be administered in a paper-based format. This test will assess visuospatial function and set-shifting ability.
- Stroop Test [ Time Frame: Pre-intervention and Post-intervention at week 4 of second treatment phase ]This test assesses inhibitory control and will be administered in a paper-based format.
- Trail-making test [ Time Frame: Pre-intervention and Post-intervention at week 4 of second treatment phase ]This will also be administered in a paper-based format. This test will assess visuospatial function and set-shifting ability.
- Stroop Test [ Time Frame: 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 [ Time Frame: 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.
- Passive Joint Angle Matching [ Time Frame: Pre-intervention and Post-intervention at week 4 of first treatment phase ]This task will be assessed in order to evaluate proprioceptive functioning.
- Passive Joint Angle Matching [ Time Frame: Pre-intervention and Post-intervention at week 4 of second treatment phase ]This task will be assessed in order to evaluate proprioceptive functioning.
- Passive Joint Angle Matching [ Time Frame: Pre-intervention and Post-intervention at week 4 of third treatment phase ]This task will be assessed in order to evaluate proprioceptive functioning.
- Parkinson Anxiety Scale [ Time Frame: Pre-intervention and Post-intervention at week 4 of first 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).
- Parkinson Anxiety Scale [ Time Frame: Pre-intervention and Post-intervention at week 4 of second 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).
- Parkinson Anxiety Scale [ Time Frame: 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).
- Unified Parkinson's disease Rating Scale Motor Subsection (UPDRS-III) [ Time Frame: Pre-intervention and Post-intervention at week 4 of first treatment phase ]A clinician administered assessment which evaluates individuals' motor symptom severity
- Unified Parkinson's disease Rating Scale Motor Subsection (UPDRS-III) [ Time Frame: Pre-intervention and Post-intervention at week 4 of second treatment phase ]A clinician administered assessment which evaluates individuals' motor symptom severity
- Unified Parkinson's disease Rating Scale Motor Subsection (UPDRS-III) [ Time Frame: 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) [ Time Frame: Pre-intervention and Post-intervention at week 4 of first 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 interve
Original Secondary Outcome: Same as current
Information By: Sun Life Financial Movement Disorders Research and Rehabilitation Centre
Dates:
Date Received: February 9, 2017
Date Started: February 24, 2017
Date Completion: August 2017
Last Updated: April 24, 2017
Last Verified: April 2017
