Progressive Abduction Loading Therapy: A Phase IIb Stroke Rehabilitation Trial with Longitudinal Tracking
渐进性外展负荷疗法:纵向追踪的 IIb 期中风康复试验
基本信息
- 批准号:10219316
- 负责人:
- 金额:$ 47.41万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2019
- 资助国家:美国
- 起止时间:2019-09-06 至 2024-08-31
- 项目状态:已结题
- 来源:
- 关键词:AcuteAdjuvantAdmission activityAffectAnatomyApoptosisAttenuatedBehavioralBrain EdemaCaringChronicChronic PhaseClinical TrialsClinical assessmentsCorticospinal TractsCouplingDataDevelopmentElbowEnrollmentEquipmentExerciseFinancial compensationForce of GravityFutureGoalsHeightImpairmentIndividualInterventionIntervention StudiesInvestigationIschemic PenumbraJointsLesionMotorMotor NeuronsMotor PathwaysMovementNecrosisNeural PathwaysNeuronal PlasticityOutpatientsParticipantPathway interactionsPatientsPhasePhase III Clinical TrialsPopulationPractice GuidelinesProductionRandomized Clinical TrialsRecoveryRehabilitation therapyResidual stateScienceShoulderSignal TransductionStandardizationStrokeSurfaceTestingTranslationsUpper ExtremityWorkarmbasechronic strokecomparison groupcomparison interventioncritical perioddosageexperimental grouphapticshemiparesisimprovedischemic injurymotor impairmentneuroimagingnovelpre-clinicalpreclinical studypreventrecruitrelating to nervous systemresponserestorationstroke recoverystroke rehabilitationsynergismsystems researchvirtual
项目摘要
Project Summary
Preclinical rehabilitation studies in the chronic phase of upper extremity stroke recovery have demonstrated the
capacity to improve independent joint control in individuals with severe impairment, by reducing the expression
of abnormal shoulder abduction/elbow flexion coupling, or flexion synergy, following a science-based data-driven
intervention approach. Two decades of quantitative motor systems research underpins the concept of
systematically targeting independent joint control in this population. The leading hypothesis explaining stroke-
related loss of independent joint control is the increased reliance on contralesional corticoreticulospinal tract for
the production of movement in the affected arm. Partial restoration of independent joint control demonstrated in
preclinical studies logically extend this hypothesis by attributing improved movement to optimized use of residual
ipsilesional corticospinal tract likely originating in the ischemic penumbra. The anatomical circuit of residual
ipsilesional corticospinal tract is the only neural pathway available for the production of independent joint control,
or in functional terms, outward reaching against gravity. With neuroimaging studies of individuals with severe
chronic stroke supporting this hypothesis, it brings to light the supposition that optimized use of penumbral
corticospinal tract may be achieved early in recovery, specifically the critical period of neural plasticity, in
individuals with severe initial motor impairment. Stroke practice guidelines conclude that individuals with severe
initial motor impairment are in the greatest need of novel and efficacious rehabilitation interventions. Therefore,
our central hypothesis is that administration of progressive abduction loading therapy, shown to elicit sustained
improvements in individuals with severe chronic stroke, will augment conventional acute and subacute
rehabilitation through improved reaching function and attenuated development of loss of independent joint
control. To test this hypothesis, we will recruit individuals with severe initial motor impairment and administer
progressive abduction loading therapy as adjuvant to conventional in-patient and day-rehabilitation. A
comparison group of dosage-matched reaching practice without abduction loading will be utilized. Study
participants will be evaluated at admission, weekly until discharge, and then every other month until 1 year
following baseline. Between group comparisons will be made over the duration of the first year of recovery (Aim
1). Approximately half of the study participants will transition to day-rehabilitation following in-patient
rehabilitation and continue to receive the study interventions. The effect of extending progressive abduction
loading therapy into subacute recovery will be tested with the addition of a dichotomous variable of enrollment
in day-rehabilitation or not (Aim 2). Efficacy and dosage data will provide a go-no-go signal for the future
administration of a large-scale pivotal phase III clinical trial. Longitudinal data will determine if progressive
abduction loading therapy attenuates the development of loss of independent joint control.
项目概要
上肢卒中康复慢性期的临床前康复研究表明
通过减少表达来改善严重损伤个体的独立联合控制能力
异常肩部外展/肘部屈曲耦合或屈曲协同作用,遵循基于科学的数据驱动
干预方法。二十年的定量运动系统研究支撑了以下概念:
系统地针对这一人群进行独立联合控制。解释中风的主要假设是
独立关节控制的相关丧失是对对侧皮质皮质脊髓束的依赖增加
受影响手臂的运动。独立联合控制的部分恢复在
临床前研究通过将运动的改善归因于残余物的优化使用,逻辑上扩展了这一假设
同病灶皮质脊髓束可能起源于缺血半暗带。残差的解剖回路
同侧皮质脊髓束是唯一可用于产生独立关节控制的神经通路,
或者用功能术语来说,就是对抗重力向外伸展。对患有严重疾病的个体进行神经影像学研究
慢性中风支持了这一假设,它揭示了优化使用半影的假设
皮质脊髓束可以在恢复早期实现,特别是在神经可塑性的关键时期,
具有严重初始运动障碍的个体。中风实践指南得出的结论是,患有严重中风的个体
最初的运动障碍最需要新颖有效的康复干预措施。所以,
我们的中心假设是,渐进性外展负荷疗法的管理已被证明可以引起持续的
严重慢性中风患者的改善将增强传统的急性和亚急性
通过改善伸手功能和减轻独立关节丧失的发展来进行康复
控制。为了检验这一假设,我们将招募患有严重初始运动障碍的个体并进行管理
渐进性外展负荷疗法作为传统住院和日间康复的辅助疗法。一个
将使用剂量匹配的无外展负荷的伸展练习的对照组。学习
参与者将在入院时接受评估,每周评估一次直至出院,然后每隔一个月评估一次,直至一年
遵循基线。将在恢复的第一年期间进行组间比较(目标
1).大约一半的研究参与者将在住院后过渡到日间康复
康复并继续接受研究干预措施。延长渐进性外展的效果
将通过添加入组二分变量来测试亚急性恢复期的负荷治疗
是否进行日间康复(目标 2)。功效和剂量数据将为未来提供禁止信号
进行大规模关键 III 期临床试验。纵向数据将决定是否渐进
外展负荷疗法可减轻独立关节控制丧失的发展。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Michael D. Ellis其他文献
Michael D. Ellis的其他文献
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{{ truncateString('Michael D. Ellis', 18)}}的其他基金
Progressive Abduction Loading Therapy: A Phase IIb Stroke Rehabilitation Trial with Longitudinal Tracking
渐进性外展负荷疗法:纵向追踪的 IIb 期中风康复试验
- 批准号:
10011891 - 财政年份:2019
- 资助金额:
$ 47.41万 - 项目类别:
Progressive Abduction Loading Therapy: A Phase IIb Stroke Rehabilitation Trial with Longitudinal Tracking
渐进性外展负荷疗法:纵向追踪的 IIb 期中风康复试验
- 批准号:
10470718 - 财政年份:2019
- 资助金额:
$ 47.41万 - 项目类别:
Progressive Abduction Loading Therapy: A Phase IIb Stroke Rehabilitation Trial with Longitudinal Tracking
渐进性外展负荷疗法:纵向追踪的 IIb 期中风康复试验
- 批准号:
9814326 - 财政年份:2019
- 资助金额:
$ 47.41万 - 项目类别:
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