Clinical trial NCT05880940: Comparing Different Rehabilitation Exercise Strategies for Improving Arm Recovery After Stroke
Official title: Comparing Different Rehabilitation Exercise Strategies for Improving Arm Recovery After Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Cerebral Vascular Accident (CVA)
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Flint Rehabilitation Devices, LLC
name: Rancho Research Institute, Inc.
name: Casa Colina Hospital and Centers for Healthcare
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-05-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to measure the effect of participating in extra arm exercise in addition to standard rehabilitation exercises in the Acute Rehabilitation Unit. This study will compare two different ways to perform the extra arm exercise. The first is following a customized program of hand and arm exercises that will be developed for study participants by an experienced rehabilitation therapist. The second is moving a participants arm back and forth when they are sitting in their wheelchair by using a moveable wheelchair arm rest (Boost).

Detailed description: For this study, the investigators hypothesize that use of movable wheelchair arm rest device during inpatient therapy will lead to significantly greater improvements in UE motor recovery than conventional treatment. The Aim is to perform a randomized controlled trial of the movable wheelchair arm rest device with inpatients with subacute stroke in three different inpatient rehabilitation facilities (N=58; Months 6-24). Participants will be \>3 days and \<3 weeks post-stroke, with initial FM scores \<42/66. All participants will be stratified by their Fugl-Meyer Arm Motor score at the baseline evaluation into two levels (0-21, 22-42) and then randomized by permuted block allocation to receive the movable wheelchair arm rest device or an electronic exercise program. All study participants will be instructed to practice moving their arm between regular therapy sessions. The primary outcome measure will be change in FM score from baseline to three-months post-stroke. The investigators hypothesize that participants who receive movable wheelchair arm rest device will have significantly greater improvements in FM score than control (p\<0.05, RM-ANCOVA) without an increase in pain or spasticity, if they exceed the putative threshold of UE motor drive needed for recovery. Success Criteria: A significantly greater increase in FM of \>4.25 points (the FM MCID40) between movable wheelchair arm rest device and control at three months.

Eligibility criteria: Inclusion Criteria:

1. 18 to 84 years of age
2. Experienced a single stroke or multiple strokes \>3 days and \< 4 weeks prior to study enrollment, and currently admitted or accepted into Acute Rehabilitation program for stroke.
3. UE Fugl-Meyer Motor Score \<42/66
4. Absence of moderate to severe shoulder pain while using the movable wheelchair arm rest device (\<6 on the 10-point visual analog pain scale)
5. Absence of severe tone at the affected UE (score \<4 on the Modified Ashworth Spasticity Scale)
6. Deem to be an appropriate candidate for manual wheelchair by ARU clinicians. A patient who has been able to transfer into a wheelchair while at ARU (with or without assistance) and has tolerated sitting in the wheelchair for at least 30 minutes.

Exclusion Criteria:

1. Subarachnoid hemorrhage
2. Presence of other neurological or psychological disorders affecting motor functions
3. Moderate to severe pain in the stroke-affected upper extremity (score \> 6 on 10-point visual analog pain scale), while using the movable wheelchair arm rest device
4. Severe tone at the affected upper extremity (score \> 4 on the Modified Ashworth Spasticity scale)
5. Severe aphasia (score of 2 or higher on the NIH stroke scale - question 9). PI may dismiss this criterion if the participant is deemed able to follow all study instructions.
6. Deficits in vision, language, attention, neglect, or other cognitive functions severe enough to interfere with safe operation of wheelchair or the movable wheelchair arm rest device.
7. Currently pregnant
8. Difficulty in understanding or complying with instructions given by the experimenter.
9. Inability to perform the experimental task that will be studied.
10. Not part of another upper extremity motor-related interventional study

Primary outcomes:
measure: Fugl-Meyer Arm Motor Assessment Score (FMAMA)
timeFrame: Baseline upon admission (assessed within 3 days upon admission), Post-intervention evaluation at discharge (assessed within 3 days before discharge) , and 3-month post-stroke evaluation (assessed within 3 days before or after 3-month post stroke date)
Secondary outcomes:
measure: Modified Ashworth Spasticity Scale
timeFrame: Baseline upon admission (assessed within 3 days upon admission), Post-intervention evaluation at discharge (assessed within 3 days before discharge), and 3-month post-stroke evaluation (assessed within 3 days before or after 3-month post stroke date)
measure: Box and Blocks Test
timeFrame: Baseline upon admission (assessed within 3 days upon admission), Post-intervention evaluation at discharge (assessed within 3 days before discharge), and 3-month post-stroke evaluation (assessed within 3 days before or after 3-month post stroke date)
measure: Shoulder subluxation Distance
timeFrame: Baseline upon admission (assessed within 3 days upon admission), Post-intervention evaluation at discharge (assessed within 3 days before discharge), and 3-month post-stroke evaluation (assessed within 3 days before or after 3-month post stroke date)
Other outcomes:
Locations:
city: Downey
country: United States
facility: Rancho Research Institute
state: California
city: Orange
country: United States
facility: University of California Irvine
state: California
city: Pomona
country: United States
facility: Casa Colina Hospital and Centers for Healthcare
state: California
Study officials:
affiliation: University of California, Irvine
name: An Do, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rancho Research Institute
name: Charles Liu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Casa Colina Research Institute
name: Emily Rosario, PhD
role: PRINCIPAL_INVESTIGATOR
References: