StrokeBoostNCT05880940
Comparing Different Rehabilitation Exercise Strategies for Improving Arm Recovery After Stroke
A study testing Boost - Moveable Wheelchair Armrest and Electronic Arm and Hand Exercise Program in people with Stroke, run by University of California, Irvine at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Stroke
- What is being tested?
- Boost - Moveable Wheelchair Armrest and Electronic Arm and Hand Exercise Program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Sep 2023to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Rancho Research Institute
Downey, California, 90242
University of California Irvine
Orange, California, 92868
Casa Colina Hospital and Centers for Healthcare
Pomona, California, 91767
About this study
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).
Read the 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
- Being tested
- Boost - Moveable Wheelchair Armrest, Electronic Arm and Hand Exercise Program
- Keywords
- Cerebral Vascular Accident (CVA)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boost - Moveable Wheelchair ArmrestDevice
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 ProgramBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Electronic Arm and Hand Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start15 Sep 2023
- Primary completion31 Jan 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Flint Rehabilitation Devices, LLC, Rancho Research Institute, Inc., Casa Colina Hospital and Centers for Healthcare, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, An Do, University of California, Irvine
- Investigators
- An Do, MD, Principal investigator, University of California, IrvineCharles Liu, MD, Principal investigator, Rancho Research Institute, Inc.Emily Rosario, PhD, Principal investigator, Casa Colina Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880940
- Sponsor's protocol ID
- 2508
- Other IDs
- 5R44HD106850-02
- Acronym
- Boost
- Status last verified
- Oct 2025
- First submitted
- 26 Apr 2023
- Last updated
- 27 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41256886
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Different Rehabilitation Exercise Strategies for Improving Arm Recovery After Stroke
- ClinicalTrials.gov ID
- NCT05880940
- Acronym / sponsor ID
- Boost / 2508
- Conditions
- Stroke
- Keywords
- Cerebral Vascular Accident (CVA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Flint Rehabilitation Devices, LLC, Rancho Research Institute, Inc., Casa Colina Hospital and Centers for Healthcare, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 30 May 2023 (actual)
- Results
- Posted 27 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Boost - Moveable wheelchair Arm rest | Experimental | Device: Boost - Moveable Wheelchair ArmrestMovable 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. |
| Electronic Arm Exercises | Active comparator | Behavioral: Electronic Arm and Hand Exercise ProgramElectronic 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. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 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)
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Boost - Moveable Wheelchair ArmrestThe 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. | Device | Boost - Moveable wheelchair Arm rest |
| Electronic Arm and Hand Exercise ProgramThese 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. | Behavioural | Electronic Arm Exercises |
Primary outcome
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)
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.
3 secondary outcomes
Modified Ashworth Spasticity Scale (MASS)
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)
Box and Blocks Test
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)
Shoulder Subluxation Distance
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41256886Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
An Do, MD principal investigator
University of California, Irvine
Charles Liu, MD principal investigator
Rancho Research Institute, Inc.
Emily Rosario, PhD principal investigator
Casa Colina Research Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Boost - Moveable Wheelchair Armrest and Electronic Arm and Hand Exercise Program in people with Stroke, run by University of California, Irvine at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05880940, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.