Assessment and Management of Post-Stroke Spasticity With Botulinum Toxin-A
Novel Assessment and Treatment Approaches for Detecting and Facilitating Functional Improvements in Post-Stroke Spasticity With Botulinum Toxin-A
Within the first year after stroke, approximately 38% of stroke survivors experience an increased resistance to movement, also called spasticity. One type of treatment that is approved for stroke survivors in Canada that could reduce spasticity is the injection of Botulinum toxin (BTX) into the affected muscle. While BTX reduces spasticity, there is limited evidence to show that BTX administration leads to functional improvements. This may occur because the outcomes aren't sensitive enough to detect change, some people may have better responses to BTX, or because BTX hasn't been paired with the right exercises to improve function. The aims of this research are: i) to determine if there is a way of improving the markers that measure change in response to treatment; and ii) to identify the ideal type of exercise that should be paired with BTX to allow the drug to have it greatest effect.
There are two primary research questions: a) What are the measures that will indicate whether a person with post-stroke spasticity will benefit from BTX therapy? It is hypothesized that EMG latency and amplitude, for those who best respond to BTX, will differ from those who demonstrate a weaker response to BTX; b)What is the ideal training approach for improving muscle function in stroke survivors receiving BTX injections? It is hypothesized that a training protocol that focuses on optimizing specific muscle activation patterns will demonstrate better outcomes than a training program designed to improve function.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ontario
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Toronto, Ontario, 캐나다, M4N 3M5
- Sunnybrook Health Sciences Centre
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- >120 days post first ischemic stroke
- Unilateral spasticity (MAS ≥ 1) of the wrist or elbow
- >18 years of age
- Medical referral for focal BoNT-A injections
- Residual active control of the wrist or elbow
Exclusion Criteria:
- Underlying neuromuscular disorders (i.e. ALS, neuropathies, myasthenia gravis)
- Inability to provide informed consent or communicate in English
- Bilateral paresis/spasticity
- Contractures
- Prescribed anti-spastic medication
공부 계획
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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활성 비교기: Standard Therapy
Coupling focal BoNT-A injections with a therapy program comprising of functional tasks.
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실험적: Optimal Muscle Activation Therapy
Coupling focal BoNT-A injections with a motor training program that focuses on developing and maintaining activation patterns in the muscle treated with BoNT-A.
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The proposed study uses a longitudinal, within-subject, pre/post intervention, cross-over design.
All participants will complete each of 4 study phases (each 12 weeks long).
These include: a) focal BTX injections in combination with either Standard Therapy or Optimal Muscle Activity Therapy; b) a three-month period where no treatment is given; c) focal BTX injections in combination either Standard Therapy or Optimal Muscle Activation Therapy; d) another three-month period where no treatment is given.
The order of treatment phases will be counter-balanced across participants.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Amplitude and timing of electromyographic signals (EMG)
기간: Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
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Change in electrical activation patterns of the target muscle(s) (i.e.
muscle receiving BTX injection) and the antagonist muscle.
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Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Motor Evoked Potential amplitude
기간: Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
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To measure the change in cortical excitability associated with the intervention.
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Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
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Goal Attainment Scale
기간: Baseline, 6 Months
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Change in Goal Attainment Scale
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Baseline, 6 Months
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Modified Ashworth Scale
기간: Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
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Change in Modified Ashworth Scale
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Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
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Modified Tardieu Scale
기간: Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
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Change in Modified Tardieu Scale
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Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
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Frequency and amplitude of electroencephalographic (EEG) activity
기간: Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
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Measurement of event-related cortical activity
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Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: George Mochizuki, PhD, Sunnybrook Health Sciences Centre
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
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. .
뇌졸중에 대한 임상 시험
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Institut National de la Santé Et de la Recherche...모병
Standard Therapy에 대한 임상 시험
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Sophiahemmet UniversityKarolinska Institutet; Linnaeus University; The Swedish School of Sport and Health Sciences; Stockholm University모병
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University of Oxford완전한
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Nebraska Methodist Health SystemAcera Surgical, Inc.종료됨