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Clinical Trials/NCT03903770
NCT03903770
Completed
N/A

Personalized Upper Extremity Rehabilitation for Persons With Moderate and Severe Impairments Due to Stroke

McGill University2 sites in 1 country32 target enrollmentSeptember 1, 2018
ConditionsStroke

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
McGill University
Enrollment
32
Locations
2
Primary Endpoint
Change from baseline Box and Blocks Test at 6 weeks
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Approximately 80% of individuals with chronic stroke present with long lasting upper extremity (UE) impairments. Advances in rehabilitation technology, such as robotics, virtual reality (VR) and neuromuscular electrical stimulation (NMES), have separately demonstrated their effectiveness in improving UE function of individuals with stroke. The potential to influence recovery may be further enhanced by combining these modalities in order to target motor deficits of the individual. Research has shown that not all persons with stroke may be able to recover hand function. In particular, such recovery depends on the integrity of the corticospinal tract (CST), which links the motor areas of the brain to the UE (and hand) musculature. Instead of using a 'one-size-fits-all' approach to UE rehabilitation, CST integrity will be assessed through transcranial magnetic stimulation (TMS), a non-invasive approach, and match the intervention to the individual's specific impairments. The perSonalized UPper Extremity Rehabilitation (SUPER) intervention is proposed, which combines robotics, VR activities, and NMES. The objectives of this study are to determine the feasibility of the SUPER intervention in individuals with moderate/severe stroke. Stroke participants will receive a 5-week intervention (3x per week) combining robotic therapy and VR activities, based on their functional level. Those with low potential for hand recovery will receive an intervention focussing on elbow and shoulder movements. For those with a good potential for hand recovery, the last 30 minutes of the robotic or VR session will be complemented by muscle-triggered NMES. Feasibility indicators associated with process, resources, management and treatment will be measured. Outcomes of UE and hand function will include the Fugl-Meyer upper extremity assessment, the Box and Block test and the ABILHAND. It is expected that feasibility criteria will be met and that the SUPER intervention will lead to significant improvements in UE impairment compared to a waitlist group.

Registry
clinicaltrials.gov
Start Date
September 1, 2018
End Date
December 1, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Philippe Archambault

Associate Professor

McGill University

Eligibility Criteria

Inclusion Criteria

  • ischemic or hemorrhagic stroke
  • moderate to severe UE impairment (score between 2 and 4 out of 7 on the Chedoke-McMaster each of the arm and hand components
  • at least 3 months post stroke
  • no longer receiving rehabilitation services.

Exclusion Criteria

  • medical instability
  • marked cognitive deficits (MiniCog score 2 or lower)
  • uncorrected visual impairments
  • shoulder pain that would limit participation in the study
  • severe spasticity at the affected UE

Outcomes

Primary Outcomes

Change from baseline Box and Blocks Test at 6 weeks

Time Frame: 6 weeks

A measure of gross motor dexterity

Change from baseline ABILHAND at 6 weeks

Time Frame: 6 weeks

A questionnaire to assess active function of the upper limbs with 23 activities, rated as impossible, difficult or easy. The scale is scored through Rasch analysis, providing a total score ranging from -6 to +6, with higher scores indicating a lower degree of upper extremity impairment.

Change from baseline Fugl-Meyer Assessment (Upper extremity section) at 6 weeks

Time Frame: 6 weeks

A performance-based measure of UE impairment describing motor recovery

Secondary Outcomes

  • Change from baseline Motor Activity Log at 6 weeks(6 weeks)
  • Change from baseline Grip Strength at 6 weeks(6 weeks)
  • Change from baseline Stroke Impact Scale at 6 weeks(6 weeks)

Study Sites (2)

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