Device-Assisted ADL Practice for Stroke Recovery

Recruiting at1 trial location

Overseen by Jun Yao, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Northwestern University

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial investigates the use of a special device called ReIn-Hand to help stroke survivors practice everyday tasks. The device assists with arm and hand movements, making it easier for participants to perform these tasks. The goal is to improve the functional use of their affected arm and hand.

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.

What data supports the idea that Device-Assisted ADL Practice for Stroke Recovery is an effective treatment?

The available research shows that using robotic devices for upper limb rehabilitation after a stroke can improve arm movement ability. One study found that robot-assisted movement training helps improve arm movement in both early and later stages of stroke recovery. Another study suggests that robot-assisted therapy can increase the amount of practice stroke survivors get, which is important for recovery. Although some findings are not conclusive due to small sample sizes, there is optimism that robotic forces, when combined with movement practice, can offer additional benefits. Overall, these studies indicate that Device-Assisted ADL Practice can be an effective treatment for stroke recovery. ^{1 2 3 4 5}

What safety data exists for device-assisted ADL practice in stroke recovery?

The RobHand exoskeleton study reported no significant adverse events, such as skin lesions or fatigue, indicating it is a safe rehabilitation technology. Users were satisfied with the device, scoring an average of 4 out of 5 on the Quebec User Evaluation of Satisfaction with Assistive Technology 2.0 Scale. Other studies on similar devices, like the HEXORR and HandSOME, focus on feasibility and potential benefits but do not provide specific safety data. Overall, existing data suggests these devices are safe for use in stroke rehabilitation. ^{2 5 6 7 8}

Is ReIn-Hand, Robot a promising treatment for stroke recovery?

Yes, ReIn-Hand, Robot is a promising treatment for stroke recovery. It helps improve arm and hand movement by using robotic devices to assist with exercises. These devices can enhance motor abilities and reduce disability by providing targeted and interactive training, which is shown to be effective in improving outcomes for stroke patients. ^{2 9 10 11 12}

Research Team

Jun Yao, PhD

Principal Investigator

Northwestern University

Eligibility Criteria

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.

Treatment Details

Interventions

• ReIn-Hand (Device-assisted Practice)
• Robot (Robot-assisted Therapy)

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.

Participant Groups

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+

Dr. Jeffrey Sherman

Northwestern University

Chief Medical Officer

MD from Northwestern University

Dr. Alicia Löffler

Northwestern University

Chief Executive Officer since 2010

PhD from the University of Massachusetts at Amherst, post-doctoral training at Caltech

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Dr. Diana W. Bianchi

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

Chief Executive Officer since 2016

MD from Stanford University

Dr. Alison Cernich

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

Chief Medical Officer since 2020

PhD in Clinical Psychology from University of Maryland

Findings from Research

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 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 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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2022]

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

Robot-assisted movement training for the stroke-impaired arm: Does it matter what the robot does? [2022]

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

Accelerometry measuring the outcome of robot-supported upper limb training in chronic stroke: a randomized controlled trial. [2021]

4. England 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. [2022]

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

Clinical effects of using HEXORR (Hand Exoskeleton Rehabilitation Robot) for movement therapy in stroke rehabilitation. [2016]

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

Hand spring operated movement enhancer (HandSOME) device for hand rehabilitation after stroke. [2020]

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

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

8. Sweden 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. [2022]

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

Robot-assisted exercise for hand weakness after stroke: a pilot study. [2016]

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

Robotics and other devices in the treatment of patients recovering from stroke. [2019]

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

Robot-Assisted Training for Upper Limb in Stroke (ROBOTAS): An Observational, Multicenter Study to Identify Determinants of Efficacy. [2021]

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

Robotics and other devices in the treatment of patients recovering from stroke. [2022]