Comparing Different Rehabilitation Exercise Strategies for Improving Arm Recovery After Stroke

NCT05880940 | Completed Results

• 2 other identifiers: 25085R44HD106850-02
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 3

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).

Conditions

Stroke

Keywords

Cerebral Vascular Accident (CVA)

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Arm Motor Assessment Score (FMAMA)

  The investigators measure the change of the Fugl-Meyer Arm Motor Assessment scores from the baseline evaluation to the 3-month post stroke follow up evaluation. Fugl-Meyer Arm Motor Assessment is a 66-point scale measuring the movement pattern of the upper extremities. The minimum score is zero and the maximum score is 66. The higher scores indicate a better outcome.

  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)

Secondary Outcomes (3)

• Modified Ashworth Spasticity Scale (MASS)

  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)

• Box and Blocks Test

  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)

• Shoulder Subluxation Distance

  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)

Study Arms (2)

Boost - Moveable wheelchair Arm rest

EXPERIMENTAL

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.

Device: Boost - Moveable Wheelchair Armrest

Electronic Arm Exercises

ACTIVE COMPARATOR

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.

Behavioral: Electronic Arm and Hand Exercise Program

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.

Boost - Moveable wheelchair Arm rest

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.

Electronic Arm Exercises

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 84 years of age
• 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.
• UE Fugl-Meyer Motor Score \<42/66
• Absence of moderate to severe shoulder pain while using the movable wheelchair arm rest device (\<6 on the 10-point visual analog pain scale)
• Absence of severe tone at the affected UE (score \<4 on the Modified Ashworth Spasticity Scale)
• 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.

You may not qualify if:

• Subarachnoid hemorrhage
• Presence of other neurological or psychological disorders affecting motor functions
• 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
• Severe tone at the affected upper extremity (score \> 4 on the Modified Ashworth Spasticity scale)
• 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.
• 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.
• Currently pregnant
• Difficulty in understanding or complying with instructions given by the experimenter.
• Inability to perform the experimental task that will be studied.
• Not part of another upper extremity motor-related interventional study

Sponsors & Collaborators

• Flint Rehabilitation Devices, LLC: collaborator
• Rancho Research Institute, Inc.: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• University of California, Irvine: lead
• Casa Colina Hospital and Centers for Healthcare: collaborator

Study Sites (3)

Rancho Research Institute

Downey, California, 90242, United States

Location

University of California Irvine

Orange, California, 92868, United States

Location

Casa Colina Hospital and Centers for Healthcare

Pomona, California, 91767, United States

Location

Related Publications (1)

• Kim SJ, Chan V, Fullmer N, Rosario ER, Kim C, Liu CY, Comellas M, Zondervan DK, Reinkensmeyer DJ, Do AH. Promoting arm movement practice with a novel wheelchair armrest early after stroke: A randomized controlled trial. ArXiv [Preprint]. 2025 Oct 2:arXiv:2510.01753v1.

  PMID: 41256886 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: An Do, M.D., Associate Professor
• Organization: University of California Irvine

and@uci.edu

(714) 456 - 2332

Study Officials

• An Do, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

• Charles Liu, MD

  Rancho Research Institute

  PRINCIPAL INVESTIGATOR

• Emily Rosario, PhD

  Casa Colina Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 30, 2023
• Study Start: September 15, 2023
• Primary Completion: January 31, 2025
• Study Completion: February 28, 2025
• Last Updated: February 27, 2026
• Results First Posted: February 27, 2026

Record last verified: 2025-10

Locations

US (3)