Comparing Different Rehabilitation Exercise Strategies for Improving Arm Recovery After Stroke

NCT ID: NCT05880940

Last Updated: 2024-07-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-15
• Study Completion Date: 2025-08-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Boost - Moveable Wheelchair Armrest

Intervention Type: 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 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.

Group Type: ACTIVE_COMPARATOR

Electronic Arm and Hand Exercise Program

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Flint Rehabilitation Devices, LLC

INDUSTRY

Sponsor Role: collaborator

Rancho Research Institute, Inc.

OTHER

Sponsor Role: collaborator

Casa Colina Hospital and Centers for Healthcare

OTHER

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

An Do

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

An Do, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Charles Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Rancho Research Institute

Emily Rosario, PhD

Role: PRINCIPAL_INVESTIGATOR

Casa Colina Research Institute

Locations

Rancho Research Institute

Downey, California, United States

Site Status: RECRUITING

University of California Irvine

Orange, California, United States

Site Status: RECRUITING

Casa Colina Hospital and Centers for Healthcare

Pomona, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Vicky Chan, PT, DPT

Role: CONTACT

vchan2@hs.uci.edu

(949) 447 - 8339

Christine Kim, OTR/L

Role: CONTACT

chrissyk@ranchoresearch.org

(562) 385 - 8116

Facility Contacts

Scott Igtanloc

Role: primary

scotti@ranchoresearch.org

Vicky Chan, PT, DPT

Role: primary

vchan2@uci.edu

949-447-8339

Niko Fullmer

Role: primary

nfullmer@casacolina.org

909-596-7733 ext. 2220

Other Identifiers

5R44HD106850-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2508

Identifier Type: -

Identifier Source: org_study_id