Clinical trial NCT03903770: Personalized Upper Extremity Rehabilitation for Persons With Stroke
Official title: Personalized Upper Extremity Rehabilitation for Persons With Moderate and Severe Impairments Due to Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single-subject with multiple baselines (AAAB)
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from baseline Fugl-Meyer Assessment (Upper extremity section) at 6 weeks
timeFrame: 6 weeks
measure: Change from baseline Box and Blocks Test at 6 weeks
timeFrame: 6 weeks
measure: Change from baseline ABILHAND at 6 weeks
timeFrame: 6 weeks
Secondary outcomes:
measure: Change from baseline Motor Activity Log at 6 weeks
timeFrame: 6 weeks
measure: Change from baseline Grip Strength at 6 weeks
timeFrame: 6 weeks
measure: Change from baseline Stroke Impact Scale at 6 weeks
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Laval
country: Canada
facility: Jewish Rehabilitation Hospital
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre de recherche sur le vieillissement
state: Quebec
Study officials:
References:
citation: Norouzi-Gheidari N, Archambault PS, Monte-Silva K, Kairy D, Sveistrup H, Trivino M, Levin MF, Milot MH. Feasibility and preliminary efficacy of a combined virtual reality, robotics and electrical stimulation intervention in upper extremity stroke rehabilitation. J Neuroeng Rehabil. 2021 Apr 14;18(1):61. doi: 10.1186/s12984-021-00851-1.