Recruiting
Phase 2

Robotic Rehabilitation & tDCS

Sponsor:

University of Calgary

Code:

NCT03888326

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

1x1 anodal tDCS

Sham tDCS

Robotic Rehabilitation

Study Details

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.

Conditions

Stroke

Study ID

NCT03888326

Start date

Mar 6, 2018

Status verified date

Mar, 2019

Completion date

Aug 31, 2020

Anticipated

Primary completion date

Aug 31, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

no intervention: Standard of Care Rehabilitation

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

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

Sham tDCS

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

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.

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 ]
  • Robotic kinaesthesia standardized score [ Time Frame: Baseline, Within 1 week of completing the 10 day intervention and 3-month follow-up ]

Central Contacts and Locations

Central contacts

Matt Chilvers, BSc

+1 403-944-1085matthew.chilvers@ucalgary.ca

Locations

Stroke Robotic and Recovery Lab, Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada, T2N 2T9

Contacts

Matthew Chilvers, BSc

+1 403-944-1085matthew.chilvers@ucalgary.ca

Mark Piitz, BSc

+1 403-944-4050robotlab@ucalgary.ca

Principal Investigator:

Sean P Dukelow, MD/PHD

More Information

Sponsor

University of Calgary

Last update posted

Mar 25, 2019

Last verified

Mar, 2019

Keywords

  • Robotic Rehabilitation
  • Proprioception
  • Transcranial Direct Current Stimulation
  • Non-invasive Brain Stimulation
  • Chronic Stroke
  • tDCS
  • Sensory Recovery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2019-03-25.