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.
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
- Type of treatment
- Medical device, Lifestyle or therapy programme
- 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
- 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
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: 1x1 anodal tDCS; Behavioral: Robotic Rehabilitation |
| 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. Receives: Device: Sham tDCS; Behavioral: Robotic Rehabilitation |
| Standard of Care Rehabilitation | No intervention | No 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.
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
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)
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
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
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.
- First posted25 Mar 2019
- Study start6 Mar 2018
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sean Dukelow, University of Calgary
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combined Effect of Robotic Rehabilitation and Transcranial Direct Current Stimulation on Proprioception in Chronic Stroke: a Pilot Study
- ClinicalTrials.gov ID
- NCT03888326
- Acronym / sponsor ID
- RoboStim / REB17-0938
- Conditions
- Stroke
- Keywords
- Robotic Rehabilitation, Proprioception, Transcranial Direct Current Stimulation, Non-invasive Brain Stimulation, Chronic Stroke, tDCS, Sensory Recovery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 6 Mar 2018 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 25 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- 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)
| Arm | Type | Receives |
|---|---|---|
| Robotic Rehabilitation plus 1x1 anodal tDCS | Experimental | Device: 1x1 anodal tDCS, Behavioral: Robotic RehabilitationReceive 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. |
| Robotic Rehabilitation plus sham tDCS | Sham comparator | Device: Sham tDCS, Behavioral: Robotic RehabilitationReceive 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. |
| Standard of Care Rehabilitation | No intervention | –No additional therapy/treatment provided. The individual continues with their normal daily routine |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1x1 anodal tDCSAlso: 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 | Device | Robotic Rehabilitation plus 1x1 anodal tDCS |
| Sham tDCSAlso: 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 | Device | Robotic Rehabilitation plus sham tDCS |
| Robotic RehabilitationAlso: 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. | Behavioural | Robotic Rehabilitation plus 1x1 anodal tDCS, Robotic Rehabilitation plus sham tDCS |
Primary outcome
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
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)
3 secondary outcomes
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
Change in Nottingham Sensory Assessment scores
Time frame: Baseline, Within 1 week of completing the 10 day intervention and 3-month follow-up
Change in Functional Independence Measure score
Time frame: Baseline, Within 1 week of completing the 10 day intervention and 3-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
- Individual participant dataSharing planned: No. No plan to make IPD available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.