This will be a randomized double blind placebo-controlled pilot study using a repeated measures design in which participants with acute ischemic stroke and upper extremity weakness are randomized to either drug or placebo
This will be a randomized double blind placebo-controlled pilot study using a repeated measures design in which participants with acute ischemic stroke and upper extremity weakness are randomized to either drug or placebo, complete therapy, and complete outcomes assessments at baseline, 4, and 12 weeks post-stroke. Target enrollment will be 10 patients per group and adaptive randomization will be used to assist with equal representation of pre-stroke selective serotonin reuptake inhibitor (SSRI) use and motor severity (Fugl-Meyer score) in each arm. The primary purpose of this pilot study is to measure adverse events, drop-out rates, feasibility of trial conductance, and establishment of effect sizes in each group in order to power a larger efficacy trial at the University of Utah. An intention to treat model will be used during the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
The active drug will be encapsulated by the University of Utah Research Pharmacy to maintain blinding.
Placebo to be capsuled to look identical to active drug (memantine)
University of Utah
Salt Lake City, Utah, United States
Fugl-Meyer Assessment
Fugl-Meyer Assessment UE and LE scales (FMUE and FMLE). Our primary outcome measures will be the scores on the FMUE and FMLE as they have been shown to have good reliability and validity. These scales measure motor impairment by asking the participant to perform various arm, hand, and leg motions. Items are scored on a 3-point scale with 0 representing no movement, 1 representing the inability to complete the entire item and 2 representing ability to complete the item as asked. Scores range from 0-66 on the FMUE and 0-34 on the FMLE with higher scores indicating better motor control. In addition, the proprioception subscale of the FM will be used to assess status of proprioception in the UE and LE. The hip, knee, ankle, big toe, shoulder, elbow, wrist, and the thumb are moved passively and the participant is asked to indicate in which direction the joint was moved.
Time frame: 30 days
Fugl-Meyer Assessment
Fugl-Meyer Assessment UE and LE scales (FMUE and FMLE). Our primary outcome measures will be the scores on the FMUE and FMLE as they have been shown to have good reliability and validity. These scales measure motor impairment by asking the participant to perform various arm, hand, and leg motions. Items are scored on a 3-point scale with 0 representing no movement, 1 representing the inability to complete the entire item and 2 representing ability to complete the item as asked. Scores range from 0-66 on the FMUE and 0-34 on the FMLE with higher scores indicating better motor control. In addition, the proprioception subscale of the FM will be used to assess status of proprioception in the UE and LE. The hip, knee, ankle, big toe, shoulder, elbow, wrist, and the thumb are moved passively and the participant is asked to indicate in which direction the joint was moved.
Time frame: 90 days
Adverse events
Participants will be contacted by the stroke research nurse after weeks 1, 2, 3, and 8 of after randomization by telephone call or inpatient visit (if in the hospital or acute inpatient rehabilitation). Participants will be asked about potential adverse events during each phone call and each clinic visit. All adverse events, serious and minor, will be recorded on an adverse event table. The study investigators will review study records after every 5 participants are enrolled to monitor for patterns of adverse events to evaluate the safety of continuing the study.
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Time frame: up to 30 days
Adverse Events
Participants will be contacted by the stroke research nurse after weeks 1, 2, 3, and 8 of after randomization by telephone call or inpatient visit (if in the hospital or acute inpatient rehabilitation). Participants will be asked about potential adverse events during each phone call and each clinic visit. All adverse events, serious and minor, will be recorded on an adverse event table. The study investigators will review study records after every 5 participants are enrolled to monitor for patterns of adverse events to evaluate the safety of continuing the study.
Time frame: 30-90 days
Motor Activity Log (MAL)
The validity of the MAL has been well established against upper extremity accelerometry. The Motor Activity Log is a self-report measure of how frequently the participant uses his or her paretic hand in 30 common daily activities, such as opening a drawer and shaving or putting on make-up. Participants rate how often they use the paretic UE in these tasks on a 6 point scale from 0 representing no use to 5 representing as much use as before the stroke. The quality of movement scale on the Motor Activity Log asks the participant to rate how well he or she perceives the task is performed with the paretic UE. The ratings are also made on a 6 point scale with 0 representing no use to 5 representing as well as before the stroke. This assessment will only be completed at post-intervention and follow-up as it is invalid assessment in the in-patient setting where participants have few opportunities to engage in the tested items.
Time frame: 30 days
Motor Activity Log (MAL)
The validity of the MAL has been well established against upper extremity accelerometry. The Motor Activity Log is a self-report measure of how frequently the participant uses his or her paretic hand in 30 common daily activities, such as opening a drawer and shaving or putting on make-up. Participants rate how often they use the paretic UE in these tasks on a 6 point scale from 0 representing no use to 5 representing as much use as before the stroke. The quality of movement scale on the Motor Activity Log asks the participant to rate how well he or she perceives the task is performed with the paretic UE. The ratings are also made on a 6 point scale with 0 representing no use to 5 representing as well as before the stroke. This assessment will only be completed at post-intervention and follow-up as it is invalid assessment in the in-patient setting where participants have few opportunities to engage in the tested items.
Time frame: 90 days
Ten Meter Walk Test
The 10 meter walk is a measure of typical gait speed. The participant is asked to walk at his/her usual pace for 10 meters along a hallway. Two trials are completed with the best time in seconds to walk the distance recorded. The test is reliable. We will videotape the walk and later use the Riverside Scale for rating quality of locomotion.
Time frame: 30 days
Ten Meter Walk Test
The 10 meter walk is a measure of typical gait speed. The participant is asked to walk at his/her usual pace for 10 meters along a hallway. Two trials are completed with the best time in seconds to walk the distance recorded. The test is reliable. We will videotape the walk and later use the Riverside Scale for rating quality of locomotion.
Time frame: 90 days
Stroke Impact Scale (SIS)
The SIS is a self-report measure of functioning after stroke at the body function, activity, and participation levels. Participants rate on a 5 point scale how frequently statements apply to them across 8 domains (strength, communication, emotion, hand use, activities of daily living, mobility, thinking, and social participation). Scores for each domain are tallied and converted to a 100-point scale. Scores across domains are also tallied and converted to a 100-point scale. The SIS has been shown to be reliable and valid. This assessment will only be completed at post-intervention and follow-up as many of the items concern activities that are only encountered in the community. Participants who are new inpatients will not have had the opportunity to engage in these activities.
Time frame: 30 days
Stroke Impact Scale (SIS)
The SIS is a self-report measure of functioning after stroke at the body function, activity, and participation levels. Participants rate on a 5 point scale how frequently statements apply to them across 8 domains (strength, communication, emotion, hand use, activities of daily living, mobility, thinking, and social participation). Scores for each domain are tallied and converted to a 100-point scale. Scores across domains are also tallied and converted to a 100-point scale. The SIS has been shown to be reliable and valid. This assessment will only be completed at post-intervention and follow-up as many of the items concern activities that are only encountered in the community. Participants who are new inpatients will not have had the opportunity to engage in these activities.
Time frame: 90 days
Cancellation Tests
These tests measure the presence of unilateral neglect. The letter cancellation task includes 40 target letters (E, R) among 130 non-target letters on an A4-sized landscape sheet (maximum score 40, cutoff point 32). The letters are arranged in five rows, each containing 34 items. The star cancellation task consists of 56 targets (small stars) and 75 non-targets (big stars, words, and letters) randomly spaced on an A4-sized landscape sheet. In these three cancellation tasks, participants are instructed to search and mark all the targets on the stimulus sheet. The total number of targets crossed out on the left and the right of each form will be tallied and the percentage.
Time frame: 30 Days
Cancellations Tests
These tests measure the presence of unilateral neglect. The letter cancellation task includes 40 target letters (E, R) among 130 non-target letters on an A4-sized landscape sheet (maximum score 40, cutoff point 32). The letters are arranged in five rows, each containing 34 items. The star cancellation task consists of 56 targets (small stars) and 75 non-targets (big stars, words, and letters) randomly spaced on an A4-sized landscape sheet. In these three cancellation tasks, participants are instructed to search and mark all the targets on the stimulus sheet. The total number of targets crossed out on the left and the right of each form will be tallied and the percentage.
Time frame: 90 Days
Grip Strength Test
Grip strength will be tested using the American Hand Therapy Association recommended protocol. Briefly, the participant will be seated in a straight backed chair with the paretic shoulder in neutral, elbow flexed, forearm half-way between supination and pronation. He or she grasps the Jamar-type dynamometer by the handle and squeezes it as hard as possible for 5 seconds. The tester gives the command "Ok, squeeze as hard as you can….harder…..harder…..relax". The test is repeated 2 more times with a 30 second rest in between squeezes. Grip strength will be measured as the average of the 3 trials to the nearest kilogram.
Time frame: 30 Days
Grip Strength Test
Grip strength will be tested using the American Hand Therapy Association recommended protocol. Briefly, the participant will be seated in a straight backed chair with the paretic shoulder in neutral, elbow flexed, forearm half-way between supination and pronation. He or she grasps the Jamar-type dynamometer by the handle and squeezes it as hard as possible for 5 seconds. The tester gives the command "Ok, squeeze as hard as you can….harder…..harder…..relax". The test is repeated 2 more times with a 30 second rest in between squeezes. Grip strength will be measured as the average of the 3 trials to the nearest kilogram.
Time frame: 90 Days
Montreal Cognitive Assessment (MoCA©)
The MoCA© is recommended by NIH and Canadian Stroke Consortium for Cognitive Assessment after Stroke. It is reliable and valid for the stroke population.
Time frame: 30 Days
Montreal Cognitive Assessment (MoCA©)
The MoCA© is recommended by NIH and Canadian Stroke Consortium for Cognitive Assessment after Stroke. It is reliable and valid for the stroke population.
Time frame: 90 Days