Robot and tDCS Based Proprioceptive Rehabilitation After Stroke

NCT03888326 | Unknown Phase 2

• 1 other identifier: REB17-0938
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Robotic limb position matching standardized score

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

  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)

  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

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

• Change in Nottingham Sensory Assessment scores

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

• Change in Functional Independence Measure score

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

Other Outcomes (2)

• tDCS Tolerability

  During 10 day intervention period

• Attention/Motivation Questionnaire

  During the 10 day intervention period

Study Arms (3)

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.

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.

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

Interventions

1x1 anodal tDCS DEVICE

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

Also known as: Direct current stimulator (Soterix Medical)

Robotic Rehabilitation plus 1x1 anodal tDCS

Sham tDCS DEVICE

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

Also known as: Direct current stimulator (Soterix Medical)

Robotic Rehabilitation plus sham tDCS

Robotic Rehabilitation 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.

Also known as: KINARM Exoskeleton (BKIN Technologies)

Robotic Rehabilitation plus 1x1 anodal tDCS; Robotic Rehabilitation plus sham tDCS

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Stroke Robotic and Recovery Lab, Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Matt Chilvers, BSc

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD PhD FRCPC

Model Details: 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)

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 25, 2019
• Study Start: March 6, 2018
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: March 25, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)