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Personalized Upper Extremity Rehabilitation for Persons With Stroke (SUPER)

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Upper extremity rehabilitation
Sponsored by
McGill University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Jewish Rehabilitation Hospital
  • Centre de recherche sur le vieillissement

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Upper extremity rehabilitation

Outcomes

Primary Outcome Measures

Change from baseline Fugl-Meyer Assessment (Upper extremity section) at 6 weeks
A performance-based measure of UE impairment describing motor recovery
Change from baseline Box and Blocks Test at 6 weeks
A measure of gross motor dexterity
Change from baseline ABILHAND at 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

Change from baseline Motor Activity Log at 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.
Change from baseline Grip Strength at 6 weeks
Maximal hand grip strength measured with a dynamometer
Change from baseline Stroke Impact Scale at 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).

Full Information

First Posted
February 28, 2019
Last Updated
February 18, 2020
Sponsor
McGill University
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1. Study Identification

Unique Protocol Identification Number
NCT03903770
Brief Title
Personalized Upper Extremity Rehabilitation for Persons With Stroke
Acronym
SUPER
Official Title
Personalized Upper Extremity Rehabilitation for Persons With Moderate and Severe Impairments Due to Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single-subject with multiple baselines (AAAB)
Masking
None (Open Label)
Masking Description
Assessor blinded to intervention and study's objectives
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Upper extremity rehabilitation
Intervention Type
Device
Intervention Name(s)
Upper extremity rehabilitation
Intervention Description
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 Measure Information:
Title
Change from baseline Fugl-Meyer Assessment (Upper extremity section) at 6 weeks
Description
A performance-based measure of UE impairment describing motor recovery
Time Frame
6 weeks
Title
Change from baseline Box and Blocks Test at 6 weeks
Description
A measure of gross motor dexterity
Time Frame
6 weeks
Title
Change from baseline ABILHAND at 6 weeks
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change from baseline Motor Activity Log at 6 weeks
Description
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.
Time Frame
6 weeks
Title
Change from baseline Grip Strength at 6 weeks
Description
Maximal hand grip strength measured with a dynamometer
Time Frame
6 weeks
Title
Change from baseline Stroke Impact Scale at 6 weeks
Description
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).
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Jewish Rehabilitation Hospital
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7V1R2
Country
Canada
Facility Name
Centre de recherche sur le vieillissement
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 4C4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33853614
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.
Results Reference
derived

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Personalized Upper Extremity Rehabilitation for Persons With Stroke

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