Investigating Therapies for Freezing of Gait
2017년 4월 24일 업데이트: 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.
연구 개요
상태
알려지지 않은
정황
상세 설명
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.
연구 유형
중재적
등록 (실제)
17
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Ontario
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Waterloo, Ontario, 캐나다, N2L 3C5
- Sun Life Financial Movement Disorders Research and Rehabilitation Centre
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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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.
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실험적: 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.
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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.
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실험적: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Gait Assessment
기간: Change from Baseline at 4 weeks of first treatment phase
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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.
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Change from Baseline at 4 weeks of first treatment phase
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Gait Assessment
기간: Change from Baseline at 4 weeks of second treatment phase
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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.
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Change from Baseline at 4 weeks of second treatment phase
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Gait Assessment
기간: Change from Baseline at 4 weeks of third treatment phase
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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.
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Change from Baseline at 4 weeks of third treatment phase
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Stroop Test
기간: Pre-intervention and Post-intervention at week 4 of first treatment phase
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This test assesses inhibitory control and will be administered in a paper-based format.
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Pre-intervention and Post-intervention at week 4 of first treatment phase
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Trail-making test
기간: Pre-intervention and Post-intervention at week 4 of first treatment phase
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This will also be administered in a paper-based format.
This test will assess visuospatial function and set-shifting ability.
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Pre-intervention and Post-intervention at week 4 of first treatment phase
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Stroop Test
기간: Pre-intervention and Post-intervention at week 4 of second treatment phase
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This test assesses inhibitory control and will be administered in a paper-based format.
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Pre-intervention and Post-intervention at week 4 of second treatment phase
|
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Trail-making test
기간: Pre-intervention and Post-intervention at week 4 of second treatment phase
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This will also be administered in a paper-based format.
This test will assess visuospatial function and set-shifting ability.
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Pre-intervention and Post-intervention at week 4 of second treatment phase
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Stroop Test
기간: Pre-intervention and Post-intervention at week 4 of third treatment phase
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This test assesses inhibitory control and will be administered in a paper-based format.
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Pre-intervention and Post-intervention at week 4 of third treatment phase
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Trail-making test
기간: Pre-intervention and Post-intervention at week 4 of third treatment phase
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This will also be administered in a paper-based format.
This test will assess visuospatial function and set-shifting ability.
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Pre-intervention and Post-intervention at week 4 of third treatment phase
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Passive Joint Angle Matching
기간: Pre-intervention and Post-intervention at week 4 of first treatment phase
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This task will be assessed in order to evaluate proprioceptive functioning.
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Pre-intervention and Post-intervention at week 4 of first treatment phase
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Passive Joint Angle Matching
기간: Pre-intervention and Post-intervention at week 4 of second treatment phase
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This task will be assessed in order to evaluate proprioceptive functioning.
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Pre-intervention and Post-intervention at week 4 of second treatment phase
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Passive Joint Angle Matching
기간: Pre-intervention and Post-intervention at week 4 of third treatment phase
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This task will be assessed in order to evaluate proprioceptive functioning.
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Pre-intervention and Post-intervention at week 4 of third treatment phase
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Parkinson Anxiety Scale
기간: Pre-intervention and Post-intervention at week 4 of first treatment phase
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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).
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Pre-intervention and Post-intervention at week 4 of first treatment phase
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Parkinson Anxiety Scale
기간: Pre-intervention and Post-intervention at week 4 of second treatment phase
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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).
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Pre-intervention and Post-intervention at week 4 of second treatment phase
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Parkinson Anxiety Scale
기간: Pre-intervention and Post-intervention at week 4 of third treatment phase
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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).
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Pre-intervention and Post-intervention at week 4 of third treatment phase
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Unified Parkinson's disease Rating Scale Motor Subsection (UPDRS-III)
기간: Pre-intervention and Post-intervention at week 4 of first treatment phase
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A clinician administered assessment which evaluates individuals' motor symptom severity
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Pre-intervention and Post-intervention at week 4 of first treatment phase
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Unified Parkinson's disease Rating Scale Motor Subsection (UPDRS-III)
기간: Pre-intervention and Post-intervention at week 4 of second treatment phase
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A clinician administered assessment which evaluates individuals' motor symptom severity
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Pre-intervention and Post-intervention at week 4 of second treatment phase
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Unified Parkinson's disease Rating Scale Motor Subsection (UPDRS-III)
기간: Pre-intervention and Post-intervention at week 4 of third treatment phase
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A clinician administered assessment which evaluates individuals' motor symptom severity
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Pre-intervention and Post-intervention at week 4 of third treatment phase
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New Freezing of Gait Questionnaire (NFOGQ)
기간: Pre-intervention and Post-intervention at week 4 of first treatment phase
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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.
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Pre-intervention and Post-intervention at week 4 of first treatment phase
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New Freezing of Gait Questionnaire (NFOGQ)
기간: Pre-intervention and Post-intervention at week 4 of second treatment phase
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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.
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Pre-intervention and Post-intervention at week 4 of second treatment phase
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New Freezing of Gait Questionnaire (NFOGQ)
기간: Pre-intervention and Post-intervention at week 4 of third treatment phase
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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.
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Pre-intervention and Post-intervention at week 4 of third treatment phase
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Rebecca Chow, BSc, Sun Life Financial Movement Disorders Research and Rehabilitation Centre
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2017년 2월 24일
기본 완료 (예상)
2017년 8월 1일
연구 완료 (예상)
2017년 8월 1일
연구 등록 날짜
최초 제출
2017년 2월 9일
QC 기준을 충족하는 최초 제출
2017년 2월 21일
처음 게시됨 (실제)
2017년 2월 27일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 4월 25일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 4월 24일
마지막으로 확인됨
2017년 4월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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Kaohsiung Medical University아직 모집하지 않음폐 선암종 | 폐암(진단) | Condition/Disease
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University of PennsylvaniaEUSA Pharma, Inc.; Castleman Disease Collaborative Network모병캐슬맨병 | 캐슬맨병 | 거대 림프절 과형성 | 혈관여포 림프 증식증 | 혈관여포 림프절 과형성 | 혈관여포성 림프종 과형성 | GLNH | 과형성, 거대 림프절 | 림프절 과형성, 거인미국
Cognitive Training에 대한 임상 시험
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Dartmouth-Hitchcock Medical CenterCenters for Disease Control and Prevention완전한
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Dartmouth-Hitchcock Medical CenterCenters for Disease Control and Prevention완전한
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Guy's and St Thomas' NHS Foundation Trust모병
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King's College LondonUniversity College, London; Brighton & Sussex Medical School완전한
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MMSx Authority Institute for Movement Mechanics...완전한
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Dokuz Eylul UniversityThe Scientific and Technological Research Council of Turkey완전한