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

Trial Summary

What is the purpose of this trial?

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).

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 data supports the effectiveness of the treatment Boost - Moveable Wheelchair Armrest and related exercise programs for stroke recovery?

Research shows that technology-assisted training, like the use of electrical stimulation and task-oriented arm training, can improve arm and hand function in stroke patients. These methods offer more challenging and varied exercises, which can enhance recovery, especially for those with severe arm impairments. ^{1 2 3 4 5}

Is the rehabilitation exercise program for stroke recovery safe for humans?

The rehabilitation exercise program for stroke recovery, including the BOOST program, has been shown to be safe in humans, with no adverse events reported in studies. Participants in these programs did not experience significant negative effects, indicating that the exercises are generally safe for use in stroke recovery. ^{6 7 8 9 10}

How is the Electronic Arm and Hand Exercise Program different from other stroke recovery treatments?

The Electronic Arm and Hand Exercise Program is unique because it uses technology-enhanced rehabilitation, potentially incorporating brain-computer interfaces and electrical stimulation to improve arm and hand function. This approach offers more challenging and varied training possibilities, especially for those with severely affected arms, compared to traditional physical or occupational therapy. ^{1 2 11 12 13}

Research Team

Charles Liu, MD

Principal Investigator

Rancho Research Institute

Emily Rosario, PhD

Principal Investigator

Casa Colina Research Institute

An Do, MD

Principal Investigator

University of California, Irvine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

References

1. Canada 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. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Task-oriented arm training for stroke patients based on remote handling technology concepts: A feasibility study. [2023]

3. United States 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Clinical evaluation of Functional Electrical Therapy in acute hemiplegic subjects. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

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

6. Switzerland pubmed.ncbi.nlm.nih.gov

Arm-Hand Boost Therapy During Inpatient Stroke Rehabilitation: A Pilot Randomized Controlled Trial. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Hand rehabilitation based on the RobHand exoskeleton in stroke patients: A case series study. [2023]

8. England pubmed.ncbi.nlm.nih.gov

H-GRASP: the feasibility of an upper limb home exercise program monitored by phone for individuals post stroke. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Commercial device-based hand rehabilitation systems for stroke patients: State of the art and future prospects. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Phase I Safety Trial: Extended Daily Peripheral Sensory Stimulation Using a Wrist-Worn Vibrator in Stroke Survivors. [2021]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Early Stroke Rehabilitation of the Upper Limb Assisted with an Electromyography-Driven Neuromuscular Electrical Stimulation-Robotic Arm. [2022]

12. Germany pubmed.ncbi.nlm.nih.gov

Upper limb movements and cerebral plasticity in post-stroke rehabilitation. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

The HAAPI (Home Arm Assistance Progression Initiative) Trial: A Novel Robotics Delivery Approach in Stroke Rehabilitation. [2019]