Rehabilitation Exercises for Stroke Recovery

(Boost Trial)

Recruiting at 2 trial locations

Overseen By Christine Kim, OTR/L

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Disqualifiers: Subarachnoid hemorrhage, Neurological disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 3 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how extra arm exercises can aid stroke recovery. Participants will either engage in a custom set of hand and arm exercises (Electronic Arm and Hand Exercise Program) or use a special wheelchair armrest (Boost - Moveable Wheelchair Armrest) that assists arm movement. The goal is to identify which method better supports recovery alongside standard rehab exercises. This trial suits individuals who have had a stroke in the last few weeks, are in a rehab program, and can use a manual wheelchair. As an unphased trial, it offers a unique opportunity to explore innovative recovery methods and contribute to advancing stroke rehabilitation techniques.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that these rehabilitation exercises are safe for stroke recovery?

Research shows that the Boost movable wheelchair armrest aids arm exercises after a stroke. Studies have found that using this device during rehab can reduce arm problems, making it easier for patients to move their arms. No serious safety issues have been reported with this device, and patients seem to handle it well.

For the Electronic Arm and Hand Exercise Program, research indicates that similar electronic and robotic exercises can improve arm function after a stroke. Many rehab programs use these exercises, which are generally safe. Reports of major risks or side effects from these exercises have not emerged.

Overall, both the Boost armrest and the electronic exercise program are considered safe options for stroke recovery, with no significant safety issues reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these rehabilitation exercises for stroke recovery because they introduce innovative approaches to enhancing post-stroke rehabilitation. The "Boost - Moveable wheelchair Arm rest" offers a unique, adaptable method for patients to engage in exercises, whether stationary or in motion, providing a personalized rehabilitation experience. Meanwhile, the "Electronic Arm Exercises" leverage digital platforms like Medbridge to deliver customizable, home-based exercise programs, integrating seamlessly with patients' daily routines. These methods are distinct from traditional rehabilitation, which often relies on in-person therapy sessions, by providing flexibility and adaptability that cater to individual patient needs and encourage consistent engagement.

What evidence suggests that this trial's treatments could be effective for stroke recovery?

Research shows that the Boost movable wheelchair armrest, which participants in this trial may receive, can help stroke patients improve arm movement. Studies found that people using Boost had better arm function than those who didn't. This device enables extra arm exercises, crucial for recovery.

For the electronic arm and hand exercise program, another treatment option in this trial, earlier studies on similar robotic-assisted exercises found that they improved arm and hand function. These exercises also enhanced daily activities and muscle strength. Combining these exercises with traditional therapy increases the chances of regaining arm movement after a stroke. ^{1 2 4 5 6}

Who Is on the Research Team?

An Do, MD

Principal Investigator

University of California, Irvine

Charles Liu, MD

Principal Investigator

Rancho Research Institute

Emily Rosario, PhD

Principal Investigator

Casa Colina Research Institute

Are You a Good Fit for This Trial?

This trial is for stroke survivors aged 18-84, within 3 days to 3 weeks post-stroke, admitted into an Acute Rehabilitation program. They should have a certain level of arm motor function (Fugl-Meyer score <42), be able to sit in a wheelchair, and not suffer from severe pain or muscle stiffness in the affected arm.

Inclusion Criteria

I had a stroke between 3 days and 3 weeks ago and am now in a rehab program for it.

I have been approved for a manual wheelchair and can sit in it for at least 30 minutes.

My arm stiffness is mild (score less than 4 on a spasticity scale).

Exclusion Criteria

Not part of another upper extremity motor-related interventional study

I have a condition affecting my movement due to nerve or mental health issues.

Difficulty in understanding or complying with instructions given by the experimenter.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive either a movable wheelchair arm rest device or an electronic exercise program during their inpatient rehabilitation stay

3 weeks

Daily sessions (inpatient)

Post-discharge Exercise

Participants continue using the assigned device or exercise program at home until the 3-month post-stroke follow-up

9 weeks

Home-based

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

1 visit (in-person) at 3 months post-stroke

What Are the Treatments Tested in This Trial?

Interventions

• Boost - Moveable Wheelchair Armrest
• Electronic Arm and Hand Exercise Program

Trial Overview The study measures how effective two additional arm exercise methods are compared to standard rehab exercises. One method uses customized hand and arm exercises designed by therapists; the other involves using a moveable wheelchair armrest called Boost.

How Is the Trial Designed?

Group I: Boost - Moveable wheelchair Arm rest Experimental Treatment 1 Intervention

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 II: Electronic Arm Exercises Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Casa Colina Hospital and Centers for Healthcare

Collaborator

Trials

11

Recruited

350+

Flint Rehabilitation Devices, LLC

Industry Sponsor

Trials

7

Recruited

240+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Rancho Research Institute, Inc.

Collaborator

Trials

9

Recruited

560+

Published Research Related to This Trial

A review of 23 studies on brain-computer interface (BCI) combined with electrical stimulation (ES) for upper limb rehabilitation found that most research focuses on stroke patients, with only 3 studies involving spinal cord injury populations.

The BCI-ES interventions were primarily conducted without therapist involvement, suggesting a need for standardization in rehabilitation practices and potential integration of therapists to enhance clinical effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scoping Review on Brain-Computer Interface-Controlled Electrical Stimulation Interventions for Upper Limb Rehabilitation in Adults: A Look at Participants, Interventions, and Technology. Jovanovic, LI., Jervis Rademeyer, H., Pakosh, M., et al.[2023]

The EMG-driven neuromuscular electrical stimulation (NMES)-robot arm significantly improved upper limb function in subacute stroke patients, particularly in wrist and hand movements, compared to traditional therapy, as shown by higher scores in the Fugl-Meyer Assessment and Action Research Arm Test after 20 training sessions.

The NMES-robot group not only achieved better motor outcomes but also demonstrated a reduction in muscle tone, indicating improved muscular coordination, which was maintained for 3 months post-treatment, while the control group showed increased muscle tone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Stroke Rehabilitation of the Upper Limb Assisted with an Electromyography-Driven Neuromuscular Electrical Stimulation-Robotic Arm. Qian, Q., Hu, X., Lai, Q., et al.[2022]

A study involving 99 post-stroke individuals showed that both robotic-assisted therapy combined with a home exercise program (HEP) and HEP alone improved upper-extremity function, indicating that both methods are effective for rehabilitation.

However, there was no significant difference in motor function improvement between the two groups, suggesting that while robotic therapy is beneficial, it may not provide additional advantages over traditional home exercise alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The HAAPI (Home Arm Assistance Progression Initiative) Trial: A Novel Robotics Delivery Approach in Stroke Rehabilitation. Wolf, SL., Sahu, K., Bay, RC., et al.[2019]

ReHab-TOAT, a technology-assisted training approach for arm-hand rehabilitation in stroke patients, was found to be feasible and motivating for both patients and therapists, with all participants expressing a desire to continue the training.

The study involved 10 participants (5 stroke patients and 5 therapists) who completed 2 training sessions, indicating that ReHab-TOAT could enhance rehabilitation efforts, although further research is needed to assess its effectiveness in improving arm-hand skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Task-oriented arm training for stroke patients based on remote handling technology concepts: A feasibility study. Elmanowski, J., Kleynen, M., Geers, RPJ., et al.[2023]

Early and intensive rehabilitative interventions that include multisensory stimulation are more effective for stroke survivors with upper limb paralysis or weakness.

Therapeutic exercises should focus on the trajectory of arm movements rather than their final position, utilizing complex and multidirectional movements to enhance cerebral plasticity and improve recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper limb movements and cerebral plasticity in post-stroke rehabilitation. Masiero, S., Carraro, E.[2019]

The Graded Repetitive Arm Supplementary Program effectively improved upper extremity function and quality of life in stroke survivors, as evidenced by significant gains in various assessments, including the Fugl-Meyer Assessment and Action Research Arm Test.

The program was successfully implemented in a community setting with high participant adherence and ongoing support, demonstrating that partnerships between nonprofit organizations and community centers can facilitate the translation of evidence-based rehabilitation interventions into real-world applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation and Evaluation of the Graded Repetitive Arm Supplementary Program (GRASP) for People With Stroke in a Real World Community Setting: Case Report. Yang, CL., Bird, ML., Eng, JJ.[2022]

The task-oriented 'motor relearning programme' is the only physiotherapy approach shown to have superior efficacy for arm rehabilitation after stroke, based on a systematic review of 40 studies.

Higher intensity motor rehabilitation can significantly speed up recovery, and various effective training techniques are available for different patient needs, such as arm ability training for mildly affected patients and constrained-induced movement therapy for those with partial deficits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evidence-based arm rehabilitation--a systematic review of the literature]. Platz, T.[2018]

The pilot study involving 18 stroke patients demonstrated that an intensive arm-hand BOOST program is safe and feasible, with no adverse events reported during the 4-week intervention.

Patients who received the BOOST program early (immediate group) showed significant improvements in upper limb function compared to those who started the program later, with 80% of early participants exceeding the minimal clinical important difference in the Fugl-Meyer assessment after 4 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arm-Hand Boost Therapy During Inpatient Stroke Rehabilitation: A Pilot Randomized Controlled Trial. Meyer, S., Verheyden, G., Kempeneers, K., et al.[2021]

An 8-week phone-monitored home exercise program for stroke patients showed high adherence, with six out of eight participants completing the program and most meeting the target of 60 minutes of exercise per day.

Participants demonstrated significant improvements in upper limb function and strength, with effect sizes indicating meaningful gains, which were maintained at three and six months post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

H-GRASP: the feasibility of an upper limb home exercise program monitored by phone for individuals post stroke. Simpson, LA., Eng, JJ., Chan, M.[2018]

Functional Electrical Therapy (FET) significantly enhances recovery in the paretic arms of stroke patients, showing larger gains in upper extremity function compared to conventional therapy alone over a 6-month period with 28 participants.

The study found that FET led to a faster recovery rate during the initial 3 weeks of treatment, although lower functioning groups showed less improvement than higher functioning groups, indicating that baseline ability may influence therapy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of Functional Electrical Therapy in acute hemiplegic subjects. Popovic, MB., Popovic, DB., Sinkjaer, T., et al.[2022]

The RobHand robotic exoskeleton is a safe rehabilitation tool for stroke patients, with no significant adverse events reported during the training sessions, and users expressed high satisfaction with its comfort and professional support.

Despite the positive safety and satisfaction outcomes, the study found no statistically significant improvements in manual function after 16 training sessions, likely due to the chronic stage of the stroke in the participants, suggesting that future research should focus on earlier intervention in subacute patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hand rehabilitation based on the RobHand exoskeleton in stroke patients: A case series study. Barria, P., Riquelme, M., Reppich, H., et al.[2023]

A systematic review of hand rehabilitation systems for stroke patients found that most commercial devices effectively improve hand function, with users reporting positive outcomes from rehabilitation training.

Game-based training protocols were particularly beneficial in making rehabilitation sessions more engaging, although there are technical limitations in non-contact devices, highlighting the need for safer and more effective rehabilitation solutions, especially during the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Commercial device-based hand rehabilitation systems for stroke patients: State of the art and future prospects. Sheng, B., Zhao, J., Zhang, Y., et al.[2023]

The TheraBracelet, a device providing low-level vibration, was found to be safe for chronic stroke survivors when worn for over 8 hours a day for 2 months, with fewer adverse events reported during the real stimulation month compared to the sham month.

Out of 25 participants, only 24% experienced mild adverse events, indicating that prolonged sensory stimulation does not significantly worsen hand function or sensation, suggesting it could be a beneficial tool for rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I Safety Trial: Extended Daily Peripheral Sensory Stimulation Using a Wrist-Worn Vibrator in Stroke Survivors. Seo, NJ., Enders, LR., Fortune, A., et al.[2021]

Citations

1. arxiv.org arxiv.org/abs/2510.01753

Promoting arm movement practice with a novel wheelchair ... This study evaluated Boost, a novel wheelchair-mounted rehabilitation device designed to assist individuals in UE motor recovery during ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9354471/

A Dynamic Wheelchair Armrest for Promoting Arm Exercise ... Arm movement recovery after stroke can improve with sufficient exercise. However, rehabilitation therapy sessions are typically not enough.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05880940

Comparing Different Rehabilitation Exercise Strategies for ... 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.

4. ui.adsabs.harvard.edu ui.adsabs.harvard.edu/abs/2025arXiv251001753K/abstract

Promoting arm movement practice with a novel wheelchair ... This study evaluated Boost, a novel wheelchair-mounted rehabilitation device designed to assist individuals in UE motor recovery during inpatient rehabilitation ...

5. researchgate.net researchgate.net/publication/396143637_Promoting_arm_movement_practice_with_a_novel_wheelchair_armrest_early_after_stroke_A_randomized_controlled_trial

Promoting arm movement practice with a novel wheelchair ... This study evaluated Boost, a novel wheelchair-mounted rehabilitation device designed to assist individuals in UE motor recovery during ...

6. arxiv.org arxiv.org/pdf/2510.01753

Promoting arm movement practice with a novel wheelchair ... This study evaluated the feasibility of using Boost to enhance movement practice during inpatient stroke rehabilitation. Participants who had recently ...