Robot and tDCS Based Proprioceptive Rehabilitation After Stroke

NCT ID: NCT03888326

Last Updated: 2019-03-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-06
• Study Completion Date: 2020-08-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

1x1 anodal tDCS

Intervention Type: DEVICE

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

Robotic Rehabilitation

Intervention Type: BEHAVIORAL

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.

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.

Group Type: SHAM_COMPARATOR

Sham tDCS

Intervention Type: DEVICE

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

Robotic Rehabilitation

Intervention Type: BEHAVIORAL

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.

Standard of Care Rehabilitation

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

Sham tDCS

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

Intervention Type: DEVICE

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Direct current stimulator (Soterix Medical); Direct current stimulator (Soterix Medical); KINARM Exoskeleton (BKIN Technologies)

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Dr. Sean Dukelow

Associate Professor, MD PhD FRCPC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stroke Robotic and Recovery Lab, Foothills Medical Centre

Calgary, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Matt Chilvers, BSc

Role: CONTACT

matthew.chilvers@ucalgary.ca

+1 403-944-1085

Facility Contacts

Matthew Chilvers, BSc

Role: primary

matthew.chilvers@ucalgary.ca

+1 403-944-1085

Mark Piitz, BSc

Role: backup

robotlab@ucalgary.ca

+1 403-944-4050

Other Identifiers

REB17-0938

Identifier Type: -

Identifier Source: org_study_id