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Personalized Upper Extremity Rehabilitation for Persons With Stroke (SUPER)

McGill University logo

McGill University

Status

Completed

Conditions

Stroke

Treatments

Device: Upper extremity rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT03903770
CRIR-1271-1017

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

32 participants in 1 patient group

Intervention
Experimental group
Description:
Upper extremity rehabilitation
Treatment:
Device: Upper extremity rehabilitation

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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