Device-Assisted ADL Practice for Stroke Recovery

Recruiting at 1 trial location

Overseen By Riegele Arceo

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Must not be taking: Botulinum toxin

Disqualifiers: Neurologic disorder, Cardiorespiratory impairment, others

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

Compensation: Varies

Number of Visits: 29

Duration: 8 weeks

54 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a device can aid in recovering arm movement after a moderate to severe stroke. Participants will practice tasks like reaching and grasping using the ReIn-Hand device and potentially a robot-assisted rehabilitation device to support their shoulder. Researchers aim to improve current treatments and help many stroke survivors regain more use of their affected arm. This trial may suit individuals with one-sided arm weakness after a stroke who can lift their arm and have some hand movement with assistance. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance recovery options for stroke survivors.

Do I need to stop my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have had botulinum toxin or similar injections in the last 6 months, you may not be eligible.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have had certain injections like botulinum toxin in the last 6 months, you may not be eligible to participate.

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

Research shows that treatments using devices like ReIn-Hand and robotic therapy are being explored to help stroke survivors regain use of their arms and hands. These devices are generally easy to use and aim to improve everyday actions like reaching and grasping.

Studies have found that ReIn-Hand helps by opening the hand, making it easier for people to perform tasks. No specific evidence of serious side effects has been found, which reassures those considering it.

Regarding robotic therapy, research suggests it can enhance arm movement and improve motor skills. Some studies have shown that this therapy is safe and can even boost brain function related to movement.

Overall, both treatments appear safe and promising for recovery after a stroke. However, it is important to consult healthcare providers to determine if they are suitable for individual needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for stroke recovery because they incorporate innovative device-assisted techniques to enhance everyday activities. ReIn-Hand helps patients with limited hand function by enabling them to perform tasks like reaching and grasping more effectively. The combination of ReIn-Hand with a robotic system not only aids hand movements but also reduces shoulder strain, offering a more holistic approach to rehabilitation. These treatments stand out because they aim to make daily activities easier for stroke survivors, potentially speeding up recovery and improving quality of life compared to traditional therapies like physical therapy alone.

What evidence suggests that this device-assisted practice is effective for stroke recovery?

Research has shown that the ReIn-Hand device, a treatment in this trial, can help stroke survivors improve hand and arm movement. This device aids in everyday tasks like reaching and gripping, which many stroke survivors find challenging. Studies indicate that practicing these tasks with the device can enhance recovery of movement skills in the affected arm.

In another part of this trial, participants will use both the ReIn-Hand and a robot. Research has found that robot-assisted therapy can boost brain changes (neuroplasticity) and improve movement abilities. Using both the device and robot together might offer even greater benefits for stroke recovery. The combination provides more intensive training, often needed for better results after a stroke. ^{1 2 3 5 6}

Who Is on the Research Team?

Jun Yao, PhD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for individuals aged 21-80 who have had a moderate to severe stroke, resulting in significant arm weakness but with some ability to move. They must be able to sit for an hour, have a certain level of cognitive function (MoCA score >=23), and not be receiving other physical rehabilitation. Exclusions include recent seizures, severe sensory impairment in the arm, prior injections affecting muscle control, other neurological disorders or serious medical conditions.

Inclusion Criteria

My skin is healthy on the arm affected by my stroke.

I have completed all my physical rehabilitation.

You are able to have an MRI scan without any problems.

Exclusion Criteria

I have a tumor in my brainstem or cerebellum.

I experience significant pain in my arms or back, rating it 5 or more out of 10.

I have severe stiffness in my elbow, wrist, and fingers.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo baseline clinical assessments and data collection including MRI and EEG

2 weeks

2 visits (in-person)

Treatment

Participants engage in 24 sessions of device-assisted practice of activities of daily living over 8 weeks

8 weeks

24 visits (in-person)

Post-Intervention Assessment

Participants undergo post-intervention assessments including clinical evaluations and data collection

1 week

1 visit (in-person)

Follow-up

Participants are monitored for sensory and motor function 3 months after intervention

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• ReIn-Hand
• Robot

Trial Overview The study tests whether using a device called ReIn-Hand alongside robot assistance can help improve the use of arms/hands during daily activities after suffering from a stroke. It measures changes in motor skills and brain adaptability post-intervention.

How Is the Trial Designed?

Group I: ReIn-hand and robot Experimental Treatment 2 Interventions

The participant will practice "reach, grasp, retrieve, and release (GR3)" a plastic jar for 40 trials per session, with the assistance of ReIn-hand to open their paretic hand and of robot to reduce the shoulder load.

Group II: ReIn-Hand Active Control 1 Intervention

The participant will practice "reach, grasp, retrieve, and release (GR3)" a plastic jar for 40 trials per session, with the assistance of ReIn-hand to open their paretic hand.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

In a pilot study involving eight chronic stroke patients who completed 18 sessions with the Hand Exoskeleton Rehabilitation Robot, significant improvements were observed in hand function, including range of motion and grip strength, indicating the robot's potential efficacy in rehabilitation.

A subgroup of six patients with lower muscle tone showed even greater gains in hand function, suggesting that the intervention may be particularly beneficial for individuals with specific characteristics, although further research is needed to optimize treatment for those with higher levels of impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical effects of using HEXORR (Hand Exoskeleton Rehabilitation Robot) for movement therapy in stroke rehabilitation. Godfrey, SB., Holley, RJ., Lum, PS.[2016]

Specialized post-stroke rehabilitation units have proven effective, but due to limited stay durations, new outpatient approaches, like interactive robotic devices, are being tested to enhance recovery for patients with motor impairments.

Robotic devices that provide active sensorimotor training for the paralyzed upper limb show promising results, suggesting that the quality and intensity of training may be more crucial for recovery than the timing of the training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotics and other devices in the treatment of patients recovering from stroke. Volpe, BT., Ferraro, M., Lynch, D., et al.[2019]

Specialized post-stroke rehabilitation units have proven effective, but due to limited stay durations, new outpatient approaches like interactive robotic devices are being tested to enhance recovery, particularly for the paralyzed upper limb.

Research indicates that the quality and intensity of training may be more crucial for recovery than the timing, with interactive robotic devices showing positive outcomes compared to noninteractive devices that only provide passive motion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotics and other devices in the treatment of patients recovering from stroke. Volpe, BT., Ferraro, M., Lynch, D., et al.[2022]

In a study involving 16 chronic stroke patients, both robot-supported and unsupported task-oriented arm-hand training did not lead to significant changes in the actual use of the affected arm-hand over an 8-week training period and 6 months after training cessation.

The findings suggest that simply measuring the amount of arm-hand use may not be sufficient; understanding the quality and types of activities performed is crucial for assessing arm-hand performance in stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerometry measuring the outcome of robot-supported upper limb training in chronic stroke: a randomized controlled trial. Lemmens, RJ., Timmermans, AA., Janssen-Potten, YJ., et al.[2021]

This systematic review aims to gather and analyze qualitative evidence on the experiences of stroke patients using robotic devices for upper limb rehabilitation, as well as the perspectives of rehabilitation professionals involved in this process.

The review will include studies that focus on adult stroke patients and professionals, ensuring a comprehensive understanding of the facilitators and barriers to using rehabilitation robots, which could enhance the effectiveness of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of patients who had a stroke and rehabilitation professionals with upper limb rehabilitation robots: a qualitative systematic review protocol. Chockalingam, M., Vasanthan, LT., Balasubramanian, S., et al.[2022]

Robot-assisted upper limb training significantly improves arm function in stroke patients, with the exoskeleton showing an average improvement of 11 points and the end-effector showing an average improvement of 6 points on the Fugl-Meyer Assessment after treatment.

The effectiveness of these devices varies by recovery stage: exoskeletons are more beneficial in the subacute phase, while end-effectors are more effective in the chronic phase, suggesting tailored approaches may enhance rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-Assisted Training for Upper Limb in Stroke (ROBOTAS): An Observational, Multicenter Study to Identify Determinants of Efficacy. Calabrò, RS., Morone, G., Naro, A., et al.[2021]

The implementation of robot-assisted upper limb therapy (RT-UL) in an inpatient rehabilitation setting significantly increased the amount of upper limb practice (repetitions and intensity) performed by subacute stroke survivors, including those with severe impairments.

This study is the first to demonstrate that RT-UL can be integrated into routine clinical practice with minimal training for therapy staff, enhancing rehabilitation outcomes without changing the duration of therapy sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitions, duration and intensity of upper limb practice following the implementation of robot assisted therapy with sub-acute stroke survivors: an observational study. Flynn, N., Froude, E., Cooke, D., et al.[2022]

A pilot study involving 12 stroke survivors with chronic moderate hemiparesis demonstrated that a new robotic device for hand rehabilitation is safe and well-tolerated, with no complications reported during the 6-week training program.

Participants showed significant improvements in motor performance across various assessments, indicating that robotic therapy could effectively enhance hand function in stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted exercise for hand weakness after stroke: a pilot study. Stein, J., Bishop, L., Gillen, G., et al.[2016]

Robot-assisted movement training can enhance arm movement ability after stroke, with initial findings suggesting that mechanically assisted reaching may improve recovery similarly to unassisted practice, although this was based on a small pilot study of 19 participants.

The study indicates that requiring patients to generate specific force patterns before movement may be more effective than simply completing movements for them, highlighting the potential for 'guided-force training' to optimize rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted movement training for the stroke-impaired arm: Does it matter what the robot does? Kahn, LE., Lum, PS., Rymer, WZ., et al.[2022]

In a feasibility study involving 12 patients with chronic stroke, combining exoskeleton robot-assisted passive range of motion with conventional hand rehabilitation led to significant improvements in upper extremity function and independence after 30 therapy sessions over 10 weeks.

The study suggests that using an exoskeleton for passive motion can effectively prepare patients for conventional rehabilitation, although sensory function did not show significant improvement, indicating the need for further research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Potential Effects of Robot-Assisted Passive Range of Motion Training in Combination with Conventional Rehabilitation on Hand Function in Patients with Chronic Stroke. Hsu, CY., Wu, CM., Huang, CC., et al.[2022]

The Hand Spring Operated Movement Enhancer (HandSOME) is a passive rehabilitation device designed to help stroke patients open their hands by using bungee cords to counteract flexor hypertonia, which is a common issue after a stroke.

Initial testing showed that HandSOME significantly increased the range of motion and functional use of the hand, even in patients with severe impairments, highlighting its potential effectiveness in stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hand spring operated movement enhancer (HandSOME) device for hand rehabilitation after stroke. Brokaw, EB., Holley, RJ., Lum, PS.[2020]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12231668/

Effects of device-assisted practice of activities of daily living ... The present study will evaluate the effectiveness of a novel interventional device, with and without shoulder abduction assistance, as part of a task-specific ...

2. researchgate.net researchgate.net/publication/393417131_Effects_of_device-assisted_practice_of_activities_of_daily_living_in_a_close-to-normal_pattern_on_upper_extremity_motor_recovery_in_individuals_with_moderate_to_severe_stroke_study_protocol_of_a_rando

Effects of device-assisted practice of activities of daily living ... Discussion The present study will evaluate the effectiveness of a novel interventional device, with and without shoulder abduction assistance, ...

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/73/NCT04077073/Prot_006.pdf

Effects of device-assisted practice of activities of daily living ... The general hypothesis is that the ReIn-hand and robot assisted GR3 intervention will result in improved hand/arm motor recovery in individuals with moderate to ...

4. smartpatients.com smartpatients.com/trials/NCT04077073

Effects of Device-assisted Practice of ADL on Arm/Hand ... This study therefore investigates effects of device-assisted practice of activities of daily living (ADL) in a close-to-normal pattern on UE ...

5. irad.nih.gov irad.nih.gov/project/effects-device-assisted-practice-activities-daily-living-close-normal-pattern-upper

EFFECTS OF DEVICE-ASSISTED PRACTICE OF ACTIVITIES ... EFFECTS OF DEVICE-ASSISTED PRACTICE OF ACTIVITIES OF DAILY LIVING IN A CLOSE-TO-NORMAL PATTERN ON UPPER EXTREMITY MOTOR RECOVERY IN INDIVIDUALS WITH ...

6. biomedeng.jmir.org biomedeng.jmir.org/2024/1/e54159

Stroke Survivors' Interaction With Hand Rehabilitation Devices In this study, we aimed to observe stroke survivors with poor hand function interacting with a range of commonly used hand rehabilitation devices.