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临床试验/NCT03888326
NCT03888326Unknown2 期

The Combined Effect of Robotic Rehabilitation and Transcranial Direct Current Stimulation on Proprioception in Chronic Stroke: a Pilot Study

University of Calgary2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年3月6日最近更新:
适应症
干预措施

试验速览

阶段
2 期
入组人数
30
试验地点
2
主要终点
Robotic limb position matching standardized score

研究概览

简要总结

Proprioceptive deficits are common following stroke, yet current evidence-based approaches for rehabilitating proprioception are limited. Robotic rehabilitation and transcranial direct current stimulation (tDCS) are two promising technologies/techniques that can potentially be used to treat these deficits. This study's purpose is to determine whether robotic rehabilitation, specifically targeted at proprioception, has the capacity to improve proprioception in a chronic stroke population. Furthermore, it is interested in whether tDCS is able to enhance any potential improvements in proprioception as a result of robotic rehabilitation.

It is hypothesized that a robotic rehabilitation will enhance proprioception in a chronic stroke population beyond standard of care rehabilitation. It is also hypothesized that individuals receiving a combination of robotic rehabilitation and tDCS will show greater proprioceptive improvements than those just receiving robotic rehabilitation.

详细描述

Background and Rationale: Proprioception is the awareness of where our limbs are in space, in the absence of vision. It is an important sense that allows us to have control over our movement and perform many activities of daily living. Every year, approximately 62,000 Canadians suffer from a stroke. Around 50% of individuals who suffer from a stroke are left with deficits in proprioception, yet clinically very little is done to rehabilitate this sense. Two novel interventions for rehabilitating proprioception are robotic rehabilitation and Transcranial Direct Current Stimulation (tDCS). Robotic rehabilitation is potentially beneficial over conventional therapies as the number of repetitions performed in a single session can be drastically increased and these movements can be performed in a well-controlled manner, something that is more difficult in conventional therapy. It is also easy to occlude vision when performing rehabilitation in a robotic environment, meaning proprioceptive retraining can be explicitly targeted. tDCS is another technology which has the potential to enhance rehabilitation. The technique involves placing two sponge electrodes over the scalp and passing a small electrical current (1-2mA) between the two electrodes, altering the membrane potential of the brain tissue through which the current passes. When tDCS has been paired with training, it has been shown to enhance learning in both healthy and stroke populations. tDCS has yet to be investigated to improve proprioception in a stroke population.

Research Question: Can a combination of robotic rehabilitation and tDCS enhance proprioception in a chronic stroke population?

Ethics: This study has been approved by the Research Ethics Board at the University of Calgary

Design: This is a Single-Blinded, Pilot, Randomized Controlled Trial with a Sham Arm

----------Methods----------

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participants are aware of whether they are in one of the robotic treatment groups but are blinded to the type of tDCS they receive (true or sham). Assessor therapist is blinded to all group allocation.

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Sex - Both male and female
  • Age: 18 years and older
  • Stroke onset: >6 months prior to enrolment
  • Stroke type: Hemorrhagic and ischaemic
  • Evidence of proprioceptive deficits as determined by a robotic assessment
  • Ability to follow simple 3-step commands

排除标准

  • Other co-morbid neurologic diagnoses (eg. Parkinson's disease)
  • Seizure disorder
  • Enrolment in concurrent upper extremity intervention trial
  • Metal implants in head
  • significant upper extremity orthopedic issues

研究组 & 干预措施

Standard of Care Rehabilitation

No Intervention

No additional therapy/treatment provided. The individual continues with their normal daily routine

Robotic Rehabilitation plus 1x1 anodal tDCS

Experimental

Receive 10 days of 1hr robotic rehabilitation with the KINARM Exoskeleton, in addition to 20 minutes, 2mA anodal tDCS (Soterix 1x1 tDCS) over the ipsilesional sensory cortex during the first 20 minutes of each robotic session. Current is ramped up to 2mA over 30 seconds and ramped back down over 30 seconds at the end of the 20 minutes.

干预措施: 1x1 anodal tDCS (Device)

Robotic Rehabilitation plus 1x1 anodal tDCS

Experimental

Receive 10 days of 1hr robotic rehabilitation with the KINARM Exoskeleton, in addition to 20 minutes, 2mA anodal tDCS (Soterix 1x1 tDCS) over the ipsilesional sensory cortex during the first 20 minutes of each robotic session. Current is ramped up to 2mA over 30 seconds and ramped back down over 30 seconds at the end of the 20 minutes.

干预措施: Robotic Rehabilitation (Behavioral)

Robotic Rehabilitation plus sham tDCS

Sham Comparator

Receive 10 days of 1hr robotic rehabilitation with the KINARM Exoskeleton, in addition to sham anodal tDCS over the ipsilesional sensory cortex. Current is ramped up to 2mA over 30 seconds and immediately ramped back down over 30 seconds. This is repeated after 20 minutes.

干预措施: Sham tDCS (Device)

Robotic Rehabilitation plus sham tDCS

Sham Comparator

Receive 10 days of 1hr robotic rehabilitation with the KINARM Exoskeleton, in addition to sham anodal tDCS over the ipsilesional sensory cortex. Current is ramped up to 2mA over 30 seconds and immediately ramped back down over 30 seconds. This is repeated after 20 minutes.

干预措施: Robotic Rehabilitation (Behavioral)

结局指标

主要结局

Robotic limb position matching standardized score

时间窗: Baseline, Within 1 week of completing the 10 day intervention and 3-month follow-up

Change in a standardized score from a baseline robotic assessment of limb position matching

Robotic kinaesthesia standardized score

时间窗: Baseline, Within 1 week of completing the 10 day intervention and 3-month follow-up

Change in a standardized score from a baseline robotic assessment of kinaesthesia (movement sense)

次要结局

  • Change in Upper-Extremity Fugl-Meyer Assessment scores(Baseline, Within 1 week of completing the 10 day intervention and 3-month follow-up)
  • Change in Nottingham Sensory Assessment scores(Baseline, Within 1 week of completing the 10 day intervention and 3-month follow-up)
  • Change in Functional Independence Measure score(Baseline, Within 1 week of completing the 10 day intervention and 3-month follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Sean Dukelow

Associate Professor, MD PhD FRCPC

University of Calgary

研究点 (2)

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