Comparing Different Rehabilitation Exercise Strategies for Improving Arm Recovery After Stroke (Boost)

November 16, 2023 updated by: An Do, University of California, Irvine
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Downey, California, United States, 90242
      • Orange, California, United States, 92868
        • Recruiting
        • University of California Irvine
        • Contact:
          • Vicky Chan, PT, DPT
          • Phone Number: 949-447-8339
          • Email: vchan2@uci.edu
      • Pomona, California, United States, 91767
        • Recruiting
        • Casa Colina Hospital and Centers for Healthcare
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 18 to 84 years of age
  2. Experienced a single stroke or multiple strokes >3 days and < 3 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Arm Motor Assessment Score (FMAMA)
Time Frame: 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)
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 (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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Ashworth Spasticity Scale
Time Frame: 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)
The investigators measure the spasticity of the upper extremity at baseline, post-intervention, and at the 3-month post stroke follow up evaluation. Spasticity is described as the resistance to passive movement. Participants are asked to relax and evaluators assess muscle resistance to passive movement at one joint at a time: Shoulder, elbow, wrist, and fingers. The evaluator will then grade the resistance on a 6-point scale for each joint. Higher scores indicate more rigid movement or more muscle tone resistance. The minimum score is zero and the maximum score is 4.
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)
Box and Blocks Test
Time Frame: 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)
The investigators measure the Box and Blocks Test scores at baseline, post-intervention, and at 3-month post stroke follow up evaluation. Participants are instructed to move as many blocks as possible, one at a time, from one compartment in a box to a second compartment over a divider for a period of 60 seconds; each block that is moved is counted, and multiple blocks moved at the same time are counted as a single block. The higher scores indicate a better outcome.
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)
Shoulder subluxation Distance
Time Frame: 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)
The investigators measure the shoulder subluxation distance at baseline, post-intervention, and at 3-month post stroke follow up evaluation. Participants are asked to be seated in a upright chair and relax their affected upper extremity. The evaluator measures the distance, in centimeter, between the inferior aspect of the acromion and the superior aspect of the humeral head. The lower scores indicate a better outcome.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Collaborators

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

Investigators

  • Principal Investigator: An Do, MD, University of California, Irvine
  • Principal Investigator: Charles Liu, MD, Rancho Research Institute
  • Principal Investigator: Emily Rosario, PhD, Casa Colina Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

April 26, 2023

First Submitted That Met QC Criteria

May 26, 2023

First Posted (Actual)

May 30, 2023

Study Record Updates

Last Update Posted (Actual)

November 18, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2508
  • 5R44HD106850-02 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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