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Investigating Therapies for Freezing of Gait

24. April 2017 aktualisiert von: Rebecca Chow, Sun Life Financial Movement Disorders Research and Rehabilitation Centre

Investigating Therapies for Freezing of Gait Targeting the Cognitive, Limbic, and Sensorimotor Domains

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.

Studienübersicht

Status

Unbekannt

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

17

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Kanada
    • Ontario
      • Waterloo, Ontario, Kanada, N2L 3C5
        • Sun Life Financial Movement Disorders Research and Rehabilitation Centre

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • A neurological disease other than PD
  • Peripheral neuropathy
  • Clinically diagnosed with dementia

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Verhalten: Cognitive Training
Training the cognitive domain may be accomplished by training various cognitive and executive functions with guided practice focusing on specific skills (e.g. visuospatial processing, executive function, memory, language, and attention). Cognitive training has been demonstrated to be efficacious in several studies in individuals with PD. Given the potential cognitive contribution to FOG episodes, this type of therapy may alleviate FOG by potentially improving upon planning, set-shifting, and/or response inhibition.
Experimental: 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.
Verhalten: Cognitive Behavioural Therapy
CBT has been demonstrated to be effective in the remediation of anxiety in individuals with PD. This may be beneficial to individuals experiencing FOG, given the evidence that anxiety may provoke FOG. During periods of elevated anxiety (e.g. walking in a threatening environment), freezers will be able to more efficiently process this limbic load resulting in greater resources available for movement control.
Experimental: 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.
Verhalten: Proprioceptive Training
Currently, studies investigating proprioceptive training as a treatment in PD are limited. However, this type of training has potential by improving proprioceptive processing. It would be expected that due to this training, when sensorimotor processing is challenged during locomotion (e.g. by removing visual feedback and preventing compensation of proprioception deficits), freezers would experience less decrements to gait due to an enhanced ability to process sensorimotor demands.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Gait Assessment
Zeitfenster: 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.
Change from Baseline at 4 weeks of first treatment phase
Gait Assessment
Zeitfenster: 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.
Change from Baseline at 4 weeks of second treatment phase
Gait Assessment
Zeitfenster: 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.
Change from Baseline at 4 weeks of third treatment phase

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Stroop Test
Zeitfenster: 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.
Pre-intervention and Post-intervention at week 4 of first treatment phase
Trail-making test
Zeitfenster: 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.
Pre-intervention and Post-intervention at week 4 of first treatment phase
Stroop Test
Zeitfenster: 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.
Pre-intervention and Post-intervention at week 4 of second treatment phase
Trail-making test
Zeitfenster: 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.
Pre-intervention and Post-intervention at week 4 of second treatment phase
Stroop Test
Zeitfenster: 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.
Pre-intervention and Post-intervention at week 4 of third treatment phase
Trail-making test
Zeitfenster: 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.
Pre-intervention and Post-intervention at week 4 of third treatment phase
Passive Joint Angle Matching
Zeitfenster: Pre-intervention and Post-intervention at week 4 of first treatment phase
This task will be assessed in order to evaluate proprioceptive functioning.
Pre-intervention and Post-intervention at week 4 of first treatment phase
Passive Joint Angle Matching
Zeitfenster: Pre-intervention and Post-intervention at week 4 of second treatment phase
This task will be assessed in order to evaluate proprioceptive functioning.
Pre-intervention and Post-intervention at week 4 of second treatment phase
Passive Joint Angle Matching
Zeitfenster: Pre-intervention and Post-intervention at week 4 of third treatment phase
This task will be assessed in order to evaluate proprioceptive functioning.
Pre-intervention and Post-intervention at week 4 of third treatment phase
Parkinson Anxiety Scale
Zeitfenster: 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).
Pre-intervention and Post-intervention at week 4 of first treatment phase
Parkinson Anxiety Scale
Zeitfenster: 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).
Pre-intervention and Post-intervention at week 4 of second treatment phase
Parkinson Anxiety Scale
Zeitfenster: 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).
Pre-intervention and Post-intervention at week 4 of third treatment phase
Unified Parkinson's disease Rating Scale Motor Subsection (UPDRS-III)
Zeitfenster: Pre-intervention and Post-intervention at week 4 of first treatment phase
A clinician administered assessment which evaluates individuals' motor symptom severity
Pre-intervention and Post-intervention at week 4 of first treatment phase
Unified Parkinson's disease Rating Scale Motor Subsection (UPDRS-III)
Zeitfenster: Pre-intervention and Post-intervention at week 4 of second treatment phase
A clinician administered assessment which evaluates individuals' motor symptom severity
Pre-intervention and Post-intervention at week 4 of second treatment phase
Unified Parkinson's disease Rating Scale Motor Subsection (UPDRS-III)
Zeitfenster: Pre-intervention and Post-intervention at week 4 of third treatment phase
A clinician administered assessment which evaluates individuals' motor symptom severity
Pre-intervention and Post-intervention at week 4 of third treatment phase
New Freezing of Gait Questionnaire (NFOGQ)
Zeitfenster: 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 interventions for FOG.
Pre-intervention and Post-intervention at week 4 of first treatment phase
New Freezing of Gait Questionnaire (NFOGQ)
Zeitfenster: Pre-intervention and Post-intervention at week 4 of second 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.
Pre-intervention and Post-intervention at week 4 of second treatment phase
New Freezing of Gait Questionnaire (NFOGQ)
Zeitfenster: 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.
Pre-intervention and Post-intervention at week 4 of third treatment phase

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Sun Life Financial Movement Disorders Research and Rehabilitation Centre

Ermittler

  • Hauptermittler: Rebecca Chow, BSc, Sun Life Financial Movement Disorders Research and Rehabilitation Centre

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

24. Februar 2017

Primärer Abschluss (Voraussichtlich)

1. August 2017

Studienabschluss (Voraussichtlich)

1. August 2017

Studienanmeldedaten

Zuerst eingereicht

9. Februar 2017

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. Februar 2017

Zuerst gepostet (Tatsächlich)

27. Februar 2017

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

25. April 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

24. April 2017

Zuletzt verifiziert

1. April 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • SunLife

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Nein

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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