NCT05880940

Comparing Different Rehabilitation Exercise Strategies for Improving Arm Recovery After Stroke

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: All
• Age: 18 Years – 84 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	Boost - Moveable Wheelchair Armrest	The movable wheelchair arm rest device is a novel wheelchair armrest that quickly clicks into a manual wheelchair frame just like a conventional armrest. However, unlike a conventional armrest, the movable wheelchair arm rest device allows users to activate arm muscles in a way that is appropriate for the early stages of stroke recovery and consistent with the Feys et al. rocking chair approach: with biomechanical support of the shoulder, without high cognitive demand, and focusing on the "out-of-synergy" movement pattern that requires elbow extension. For the study, the investigators ask participants to exercise using Boost for a 30-minute period per day for 5 times a week in addition to their regular therapy until their discharge from the unit.
BEHAVIORAL	Electronic Arm and Hand Exercise Program	These exercises will be assigned to the participants electronically using a commercial home exercise program platform commonly used by hospital systems (i.e.: Medbridge). They will be encouraged to exercise for 30 min/day in addition to the regular rehabilitation therapy at ARU. These exercises will be monitored and supervised by therapists who have been trained in the study protocol. Once participants are discharged from the unit, they will be allowed to keep the electronic exercise program until their 3-month post stroke follow up visit, the last visit of the study. For this study, the investigators ask participants to exercise following this customized arm and hand exercise program for a 30-minute period per day for 5 times a week in addition to their regular therapy until their discharge from the unit.

Timeline

• Start date: 2023-09-15
• Primary completion: 2025-01-31
• Completion: 2025-02-28
• First posted: 2023-05-30
• Last updated: 2026-02-27
• Results posted: 2026-02-27

Locations

3 sites across 1 country: United States