Robot-Assisted Hand Training for Stroke

Overseen By Vicky Chan, PT, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Disqualifiers: Pregnant, Advanced diseases, Major neurological, others

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

Compensation: Varies

Number of Visits: 9

Duration: 3 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators would like to investigate the effectiveness of somatosensory training for robot-assisted hand motor rehabilitation after stroke.

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, it does mention that you should not plan to change any current rehabilitation therapy during the study.

What data supports the effectiveness of the treatment New FINGER, Proprioception Extension Trainer for stroke?

Research shows that robot-assisted training can improve proprioception (awareness of body position) and motor function in stroke survivors, with studies demonstrating improved proprioceptive acuity and modest gains in hand movement range after using similar robotic therapies. ^{1 2 3 4 5}

Is robot-assisted hand training safe for stroke patients?

Yes, studies have shown that robot-assisted hand training, like the ArmAssist robotic system, is safe for stroke patients, with no adverse events reported during trials. ^{1 6 7 8 9}

How does the New FINGER, Proprioception Extension Trainer treatment differ from other stroke treatments?

The New FINGER, Proprioception Extension Trainer is unique because it uses a robot-assisted approach to enhance proprioception (awareness of body position) and motor function in stroke survivors. This treatment focuses on providing somatosensory feedback to improve motor control, which is not typically emphasized in conventional stroke therapies. ^{1 3 4 5 9}

Research Team

David Reinkensmeyer, Ph.D

Principal Investigator

University of California, Irvine

Eligibility Criteria

This trial is for individuals aged 18 to 85 who have had a single ischemic stroke at least six months ago and can move at least three blocks in the Box and Block Test. It's not suitable for those with less than a year to live, severe cognitive impairments, pregnant or breastfeeding women, anyone planning changes in other rehab therapies during the study, or those with certain medical conditions as assessed by the team physician.

Inclusion Criteria

I can move at least 3 blocks in the Box and Block Test.

I had a stroke confirmed by imaging more than 6 months ago.

I am between 18 and 85 years old.

Exclusion Criteria

You have a significant neurological disease.

I have noticed a significant drop in my alertness or ability to understand language or pay attention.

You are currently participating in another study about stroke or recovering from a stroke.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo FINGER robotic training with or without physical assistance and proprioceptive exercises 3 times a week

3 weeks

9 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• New FINGER
• Proprioception Extension Trainer

Trial Overview The trial is testing 'New FINGER', which is a form of robot-assisted hand movement training combined with somatosensory training designed to aid rehabilitation after a stroke. The effectiveness of this new intervention will be evaluated against standard care practices.

Participant Groups

Group I: Group C Experimental Treatment 1 Intervention

Participants will undergo new FINGER robotic training with physical assistance and proprioceptive exercises 3 times a week for a period of 3 weeks.

Group II: Group B Experimental Treatment 1 Intervention

Participants will undergo new FINGER robotic training with physical assistance 3 times a week for a period of 3 weeks.

Group III: Group A Experimental Treatment 1 Intervention

Participants with undergo new FINGER robotic training with no physical assistance 3 times a week for a period of 3 weeks.

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

University of Idaho

Collaborator

Trials

21

Recruited

2,800+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

The Hand Exoskeleton Rehabilitation Robot (HEXORR) therapy showed promising results in improving active finger and thumb range of motion in four chronic stroke patients after 18 sessions, indicating its potential effectiveness in rehabilitation.

The therapy was well-received by participants and is particularly beneficial for patients with mild to moderate spasticity, suggesting it can assist in overcoming resistance to hand extension post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hand function recovery in chronic stroke with HEXORR robotic training: A case series. Godfrey, SB., Schabowsky, CN., Holley, RJ., et al.[2020]

A four-week robot-assisted rehabilitation program significantly improved hand function in stroke patients, with greater benefits observed in those receiving continuous active therapy compared to those who had a mix of passive and active therapy.

Both treatment groups showed improvements in various hand function assessments, but the full-term intervention group demonstrated superior results, indicating that longer active therapy leads to better recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual finger synchronized robot-assisted hand rehabilitation in subacute to chronic stroke: a prospective randomized clinical trial of efficacy. Hwang, CH., Seong, JW., Son, DS.[2016]

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 ArmAssist robotic system significantly improved upper limb motor function in subacute stroke patients compared to conventional training, with a notable increase in Fugl-Meyer Assessment scores (18.0 vs. 7.5) after 3 weeks of training.

The study involved 26 participants who trained 5 days a week for 3 weeks, and importantly, there were no adverse events reported, indicating that the ArmAssist is a safe intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ArmAssist Robotic System versus Matched Conventional Therapy for Poststroke Upper Limb Rehabilitation: A Randomized Clinical Trial. Tomić, TJ., Savić, AM., Vidaković, AS., et al.[2018]

In a clinical trial involving 15 individuals with chronic stroke, the modified robotic device HEXORR II significantly improved hand function, as evidenced by increased Fugl-Meyer scores and reduced flexor hypertonia after 12 or 24 therapy sessions.

While the robotic therapy enhanced finger movement and range of motion, it did not lead to improvements in overall functional tasks, suggesting that future studies should integrate the device with more practical hand activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot test of dosage effects in HEXORR II for robotic hand movement therapy in individuals with chronic stroke. Chen, J., Black, I., Nichols, D., et al.[2022]

References

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

A robot-assisted sensorimotor training program can improve proprioception and motor function in stroke survivors. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Effects of a robot-aided somatosensory training on proprioception and motor function in stroke survivors. [2022]

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

Hand function recovery in chronic stroke with HEXORR robotic training: A case series. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Individual finger synchronized robot-assisted hand rehabilitation in subacute to chronic stroke: a prospective randomized clinical trial of efficacy. [2016]

5. 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]

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

ArmAssist Robotic System versus Matched Conventional Therapy for Poststroke Upper Limb Rehabilitation: A Randomized Clinical Trial. [2018]

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

Use of a Portable Assistive Glove to Facilitate Rehabilitation in Stroke Survivors With Severe Hand Impairment. [2019]

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

Proprioceptive assessment in clinical settings: Evaluation of joint position sense in upper limb post-stroke using a robotic manipulator. [2018]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Pilot test of dosage effects in HEXORR II for robotic hand movement therapy in individuals with chronic stroke. [2022]