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Robot and tDCS Based Proprioceptive Rehabilitation After Stroke (RoboStim)

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ClinicalTrials.gov Identifier: NCT03888326
Recruitment Status : Recruiting
First Posted : March 25, 2019
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Sean Dukelow, University of Calgary

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Stroke Device: 1x1 anodal tDCS Device: Sham tDCS Behavioral: Robotic Rehabilitation Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are assigned to one of 3 groups for the duration of the study (robotic rehabilitation plus anodal tDCS, robotic rehabilitation plus sham tDCS, standard of care rehabilitation)
Masking: Double (Participant, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: The Combined Effect of Robotic Rehabilitation and Transcranial Direct Current Stimulation on Proprioception in Chronic Stroke: a Pilot Study
Actual Study Start Date : March 6, 2018
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Robotic Rehabilitation plus 1x1 anodal tDCS
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.
Device: 1x1 anodal tDCS
20 minutes of 2mA anodal tDCS applied by a Soterix Medical 1x1 tDCS device while the participants are doing the robotic rehabilitation
Other Name: Direct current stimulator (Soterix Medical)

Behavioral: Robotic Rehabilitation
10 days of robotic rehabilitation targeted at proprioception. Therapy is conducted for 1 hour each day for 10 consecutive days (excluding weekends), in combination with either anodal or sham tDCS.
Other Name: KINARM Exoskeleton (BKIN Technologies)

Sham Comparator: Robotic Rehabilitation plus sham tDCS
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.
Device: Sham tDCS
Sham 2mA anodal tDCS applied by a Soterix Medical 1x1 tDCS device while the participants are doing the robotic rehabilitation
Other Name: Direct current stimulator (Soterix Medical)

Behavioral: Robotic Rehabilitation
10 days of robotic rehabilitation targeted at proprioception. Therapy is conducted for 1 hour each day for 10 consecutive days (excluding weekends), in combination with either anodal or sham tDCS.
Other Name: KINARM Exoskeleton (BKIN Technologies)

No Intervention: Standard of Care Rehabilitation
No additional therapy/treatment provided. The individual continues with their normal daily routine



Primary Outcome Measures :
  1. Robotic limb position matching standardized score [ Time Frame: 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

  2. Robotic kinaesthesia standardized score [ Time Frame: 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)


Secondary Outcome Measures :
  1. Change in Upper-Extremity Fugl-Meyer Assessment scores [ Time Frame: Baseline, Within 1 week of completing the 10 day intervention and 3-month follow-up ]
    Difference in subscale scores on the Upper-Extremity Fugl-Meyer Assessment - both Motor (max 66) and Sensory (max 12) components. Higher scores indicate better outcome.

  2. Change in Nottingham Sensory Assessment scores [ Time Frame: Baseline, Within 1 week of completing the 10 day intervention and 3-month follow-up ]
    Difference in subscale scores on the Nottingham Sensory Assessment - upper extremity only (Light touch, temperature, pinprick, pressure, tactile localization, bilateral simultaneous touch, proprioception - max score 12 for each subscale)

  3. Change in Functional Independence Measure score [ Time Frame: Baseline, Within 1 week of completing the 10 day intervention and 3-month follow-up ]
    Difference in score on the Functional Independence Measure (Higher scores indicate better outcome, max score 126)


Other Outcome Measures:
  1. tDCS Tolerability [ Time Frame: During 10 day intervention period ]
    The questionnaire will be completed after every session

  2. Attention/Motivation Questionnaire [ Time Frame: During the 10 day intervention period ]
    The questionnaire will be completed before and after every session. Higher scores indicate greater motivation, max score = 90



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03888326


Contacts
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Contact: Matt Chilvers, BSc +1 403-944-1085 matthew.chilvers@ucalgary.ca

Locations
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Canada, Alberta
Stroke Robotic and Recovery Lab, Foothills Medical Centre Recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Matthew Chilvers, BSc    +1 403-944-1085    matthew.chilvers@ucalgary.ca   
Contact: Mark Piitz, BSc    +1 403-944-4050    robotlab@ucalgary.ca   
Principal Investigator: Sean P Dukelow, MD/PHD         
Sponsors and Collaborators
University of Calgary

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Responsible Party: Dr. Sean Dukelow, Associate Professor, MD PhD FRCPC, University of Calgary
ClinicalTrials.gov Identifier: NCT03888326     History of Changes
Other Study ID Numbers: REB17-0938
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to make IPD available to other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Sean Dukelow, University of Calgary:
Robotic Rehabilitation
Proprioception
Transcranial Direct Current Stimulation
Non-invasive Brain Stimulation
Chronic Stroke
tDCS
Sensory Recovery

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases