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StrokePhase 2RoboStimNCT03888326

Robot and tDCS Based Proprioceptive Rehabilitation After Stroke

A Phase 2 study testing 1x1 anodal tDCS and Robotic Rehabilitation in people with Stroke, run by University of Calgary at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Stroke
What is being tested?
1x1 anodal tDCS and Robotic Rehabilitation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteCanada
Study dates
6 Mar 2018to 31 Aug 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site, 1 recruiting
  • Stroke Robotic and Recovery Lab, Foothills Medical Centre

    Calgary, Alberta, T2N 2T9

    Matthew Chilvers, BSc, +1 403-944-1085, matthew.chilvers@ucalgary.ca

    Mark Piitz, BSc, +1 403-944-4050, robotlab@ucalgary.ca

    Recruiting

Other trials in Canada

About this study

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

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.

Read the detailed description

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----------

Recruitment: 30 individuals with proprioceptive deficits beyond 6-months post-stroke are being recruited from the outpatient stroke community in Calgary, Alberta, Canada.

Randomization: Individuals are randomized into one of three groups: robotic rehabilitation plus anodal tDCS, robotic rehabilitation plus sham tDCS or standard of care rehabilitation.

Robotic Intervention: The robotic rehabilitation intervention consists of 10-days of robotic therapy in the Kinesiological Instrument for Normal and Altered Reaching Movements (KINARM) Exoskeleton. Robotic rehabilitation is conducted for 1 hour each day, on 10 consecutive days (excluding weekends). Therapy is tailored specifically towards rehabilitating proprioception and consists of a battery of 5 simple video game-like tasks. Each task is performed for 10-15 minutes each day. The order in which these tasks are completed are pseudo-randomized each day. Each day a motivation questionnaire will be completed.

tDCS Intervention: In addition to robotic rehabilitation, those in the tDCS group will also receive 20 minutes of 2mA anodal tDCS. This is applied during the first 20 minutes of each robotic session and is targeted over the ipsilesional sensory cortex. For the sham condition, the same setup will be used. Each day a tDCS tolerability questionnaire will be completed.

Assessments: All subjects will undergo 3 robotic assessments of proprioceptive performance, one at baseline (day 1), one immediately after the intervention (day 12) and one more at 3 months follow up. Two components of proprioception will be assessed during these robotic assessments (position sense and movement sense). Robotic assessments will be conducted in the same robotic exoskeleton that the therapy is delivered in.

A variety of clinical scales (Fugl-Meyer Assessment, Functional Independence Measure, and Nottingham Sensory Scale) will be collected at each time point. These will be secondary outcome measures. Performance on a robotic assessment of visually-guided reaching will also be a secondary outcome measure. All clinical assessments will be performed by a blinded assessor therapist.

Data analysis: Primary outcome measures will be analysed using a repeated measures ANOVA. Comparisons will be made between groups at each assessment time points. Secondary outcome measures and questionnaire data will also be analysed with a repeated measures ANOVA.

Conditions
Stroke
Being tested
1x1 anodal tDCS, Sham tDCS, Robotic Rehabilitation
Keywords
Robotic Rehabilitation, Proprioception, Transcranial Direct Current Stimulation, Non-invasive Brain Stimulation, Chronic Stroke, tDCS, Sensory Recovery
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 1x1 anodal tDCSDevice

    Also called Direct current stimulator (Soterix Medical)

    20 minutes of 2mA anodal tDCS applied by a Soterix Medical 1x1 tDCS device while the participants are doing the robotic rehabilitation

  • Sham tDCSDevice

    Also called Direct current stimulator (Soterix Medical)

    Sham 2mA anodal tDCS applied by a Soterix Medical 1x1 tDCS device while the participants are doing the robotic rehabilitation

  • Robotic RehabilitationBehavioural

    Also called KINARM Exoskeleton (BKIN Technologies)

    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.

Study groups in NCT03888326
Study groupRoleWhat they receive
Robotic Rehabilitation plus 1x1 anodal tDCSExperimentalReceive 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.
Receives: Device: 1x1 anodal tDCS; Behavioral: Robotic Rehabilitation
Robotic Rehabilitation plus sham tDCSSham comparatorReceive 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.
Receives: Device: Sham tDCS; Behavioral: Robotic Rehabilitation
Standard of Care RehabilitationNo interventionNo additional therapy/treatment provided. The individual continues with their normal daily routine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Robotic limb position matching standardized score

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

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

  2. Robotic kinaesthesia standardized score

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

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

Secondary outcomes (3)
  1. Change in Upper-Extremity Fugl-Meyer Assessment scores

    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.

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

  2. Change in Nottingham Sensory Assessment scores

    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)

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

  3. Change in Functional Independence Measure score

    Difference in score on the Functional Independence Measure (Higher scores indicate better outcome, max score 126)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2019
  2. Study start6 Mar 2018
  3. Primary completion31 Aug 2020 (estimated)
  4. Study completion31 Aug 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03888326
Sponsor's protocol ID
REB17-0938
Acronym
RoboStim
Status last verified
Mar 2019
First submitted
18 Mar 2019
Last updated
25 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No plan to make IPD available to other researchers

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 1x1 anodal tDCS and Robotic Rehabilitation in people with Stroke, run by University of Calgary at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Matt Chilvers, BSc (+1 403-944-1085, matthew.chilvers@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Robotic limb position matching standardized score (time frame: Baseline, Within 1 week of completing the 10 day intervention and 3-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2019.

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