Stroke Clinical Trial - Personalized Upper Extremity Rehabilitation for

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Stroke

Clinical Trial Details

NCT number	NCT03903770
Study type	Interventional
Source	McGill University
Contact
Status	Completed
Phase	N/A
Start date	September 1, 2018
Completion date	December 1, 2019

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Personalized Upper Extremity Rehabilitation for Persons With Stroke — SUPER

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms