Personalized Upper Extremity Rehabilitation for Persons With Stroke (SUPER)
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|ClinicalTrials.gov Identifier: NCT03903770|
Recruitment Status : Completed
First Posted : April 4, 2019
Last Update Posted : February 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Device: Upper extremity rehabilitation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|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|
|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|
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.
- 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
- Change from baseline Box and Blocks Test at 6 weeks [ Time Frame: 6 weeks ]A measure of gross motor dexterity
- 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.
- 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.
- Change from baseline Grip Strength at 6 weeks [ Time Frame: 6 weeks ]Maximal hand grip strength measured with a dynamometer
- 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).
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
|Jewish Rehabilitation Hospital|
|Laval, Quebec, Canada, H7V1R2|
|Centre de recherche sur le vieillissement|
|Sherbrooke, Quebec, Canada, J1H 4C4|