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Personalized Upper Extremity Rehabilitation for Persons With Stroke (SUPER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03903770
Recruitment Status : Completed
First Posted : April 4, 2019
Last Update Posted : February 19, 2020
Sponsor:
Information provided by (Responsible Party):
Philippe Archambault, McGill University

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.

Condition or disease Intervention/treatment Phase
Stroke Device: Upper extremity rehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: single-subject with multiple baselines (AAAB)
Masking: None (Open Label)
Masking Description: Assessor blinded to intervention and study's objectives
Primary Purpose: Treatment
Official Title: Personalized Upper Extremity Rehabilitation for Persons With Moderate and Severe Impairments Due to Stroke
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Intervention
Upper extremity rehabilitation
Device: Upper extremity rehabilitation
Participants receive the SUPER intervention 3 times per week for 1 hr, during 4 weeks. For participants with a low recovery potential for hand function, the SUPER interventions consists in robot-assisted reaching movements and unilateral and bilateral VR activities. The robot-assisted activity consists of a reaching task to six targets placed at maximal reach distance. For the VR activity, we use a reach and grasp VR activity based on a shopping task. Participants with good potential for hand recovery also receive 30 min of electromyography-triggered muscle stimulation, combined with the VR activity. The muscle stimulation is triggered when the participant attempts to grasp a virtual object and helps with hand opening movements.




Primary Outcome Measures :
  1. 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

  2. Change from baseline Box and Blocks Test at 6 weeks [ Time Frame: 6 weeks ]
    A measure of gross motor dexterity

  3. 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.


Secondary Outcome Measures :
  1. Change from baseline Motor Activity Log at 6 weeks [ Time Frame: 6 weeks ]
    A questionnaire rating the quality and frequency of use of the upper extremity in 14 everyday tasks. Each task is rated on two scales: quantity, assessing how much the affected extremity is used in the task; and quality, assessing how well does the affected extremity perform in the task. A 0 to 5 scale is used for quantity and quality (0 = not at all; 5 = same as before stroke). Answers are averaged for each sub scale and a percentage is calculated. A higher score indicates lower level of impairment.

  2. Change from baseline Grip Strength at 6 weeks [ Time Frame: 6 weeks ]
    Maximal hand grip strength measured with a dynamometer

  3. Change from baseline Stroke Impact Scale at 6 weeks [ Time Frame: 6 weeks ]
    A stroke-specific health status measure featuring 16 items capturing daily activities. This scale has 8 sub-scales, evaluating: strength, hand function, mobility, activities of daily living, emotion, memory, communication and social participation. Each is rated on a 0 to 100 range (100 corresponding to least impact of stroke). An overall score is also calculated (average of sub-scales).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03903770


Locations
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Canada, Quebec
Jewish Rehabilitation Hospital
Laval, Quebec, Canada, H7V1R2
Centre de recherche sur le vieillissement
Sherbrooke, Quebec, Canada, J1H 4C4
Sponsors and Collaborators
McGill University
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Responsible Party: Philippe Archambault, Associate Professor, McGill University
ClinicalTrials.gov Identifier: NCT03903770    
Other Study ID Numbers: CRIR-1271-1017
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases