Comparing Different Rehabilitation Exercise Strategies for Improving Arm Recovery After Stroke

Part of paid clinical trials in Downey, California.

Sponsor
University of California, Irvine
Study ID
NCT05880940
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 84 Years
Healthy Volunteers
Not accepted

Interventions

  • Boost - Moveable Wheelchair Armrest — DEVICE
    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.
  • Electronic Arm and Hand Exercise Program — BEHAVIORAL
    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.

Study Details

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).

Key Dates

Start date
Sep 15, 2023
Status verified
Oct 2025
Primary completion
Jan 31, 2025
Completion
Feb 28, 2025

Study Design

Enrollment
35 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Boost - Moveable wheelchair Arm rest
    Movable wheelchair arm rest device group: participants in this group will be provided with a wheelchair equipped with movable wheelchair arm rest device and will be trained by training therapists on how to use the device. Therapists will determine if the participant is capable of using the device in either a stationary mode or overground mode. Afterwards, participants will be allowed to utilize the device within the inpatient facility on their own. The investigators encourage at least 30 minutes per day of device use, although this is not required or limited to 30 minutes. Therapists may adjust the difficulty of the device utilize to provide additional challenge as they deem suitable for the participant. Once participants are discharged from the unit, they will be allowed to keep the movable wheelchair arm rest devices until their 3-month post stroke follow up visit, the last visit of the study.
  • Active Comparator: Electronic Arm Exercises
    Electronic exercise program designed by training therapists. 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 Acute Rehab Unit (ARU), although this is not required or limited to 30 minutes. Therapists may adjust the difficulty of exercise program to provide additional challenge as they deem suitable for the participant. 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.

Primary Outcome Measure

Fugl-Meyer Arm Motor Assessment Score (FMAMA) [ Time Frame: Baseline upon admission (assessed within 3 days upon admission), Post-intervention evaluation at discharge (At discharge: assessed up to 3 weeks post baseline), and 3-month post-stroke evaluation (Follow up occurred at Month 3 after Baseline) ]

Locations (3)

FacilityCityStateZIPSite coordinators
Rancho Research InstituteDowneyCalifornia90242-
University of California IrvineOrangeCalifornia92868-
Casa Colina Hospital and Centers for HealthcarePomonaCalifornia91767-

Find similar trials in Downey, CA

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Rancho Research Institute· Downey, CAUniversity of California Irvine· Orange, CACasa Colina Hospital and Centers for Healthcare· Pomona, CA

Related Studies