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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of robot-assisted hand training in helping people regain hand movement after a stroke. Participants will use a device called the New FINGER, with some also performing exercises to enhance body position sensing using the Proprioception Extension Trainer. The trial aims to determine if these methods improve hand function. It suits individuals who experienced a single ischemic stroke over six months ago and can move blocks in a simple test. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could enhance stroke recovery therapies.

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 prior data suggests that this robot-assisted hand training is safe for stroke rehabilitation?

Research shows that robot-assisted therapy, such as the New FINGER robotic training, is generally well-received by patients recovering from a stroke. Studies have found significant improvements in movement and muscle strength, indicating the therapy's safety and effectiveness. Reports of major negative side effects with this type of rehabilitation are absent.

Research supports the safe use of the Proprioception Extension Trainer in stroke recovery. Proprioceptive exercises help patients improve their awareness of body position, which is crucial for recovery. The wearable technology used in this training has proven effective without causing harm.

Both treatments, according to current research, appear safe for participants, with studies showing positive results and no serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Robot-Assisted Hand Training for stroke rehabilitation because it offers a novel approach compared to traditional methods like physical therapy and occupational therapy. This trial uses the New FINGER robotic training, which provides precise, consistent hand movements, and can be done with or without physical assistance. The inclusion of proprioceptive exercises adds another layer of innovation by helping patients improve their sense of hand position and movement. Unlike standard therapies, this robotic approach aims to enhance motor recovery and proprioception more effectively in a shorter time frame.

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

Research has shown that using robots can significantly aid stroke patients in improving movement, particularly in their hands. A review of 13 studies found that robots can increase hand strength and reduce fatigue. Other studies suggest that robotic training can enhance hand use. In this trial, participants in Group A will undergo new FINGER robotic training without physical assistance, while those in Group B will receive the same training with physical assistance. Group C participants will experience new FINGER robotic training with physical assistance and proprioceptive exercises.

For the Proprioception Extension Trainer, exercises that increase awareness of body position, combined with dual-task activities, can effectively support stroke recovery. This method improves balance and overall movement, making it a promising option for rehabilitation. Both treatments offer hope for better hand function after a stroke. ^{4 5 6 7 8}

Who Is on the Research Team?

David Reinkensmeyer, Ph.D

Principal Investigator

University of California, Irvine

Are You a Good Fit for This Trial?

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.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12318999/

Systematic review and meta-analysis of effectiveness of ... This meta-analysis of 13 RCTs confirms that robotic interventions significantly improve post-stroke motor outcomes, especially in the upper ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0967586825004187

The impact of robotic hand rehabilitation on hand function ... This study suggests that robotic hand treatment with Amadeo®, combined with traditional methods, reduces fatigue in stroke patients with hand impairments.

3. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-024-01372-3

Effect of task-oriented training assisted by force feedback ... Hand performance improved in patients with stroke after 4 weeks of task-oriented training. The use of a force feedback hand rehabilitation robot ...

4. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.124.048183?doi=10.1161/STROKEAHA.124.048183

Effects of Robot-Assisted Therapy for Upper Limb ... Robot-assisted therapy demonstrates statistically significant improvements in motor function recovery and muscle strength in stroke patients, ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38745227/

Effect of task-oriented training assisted by force feedback ... This study aimed to investigate the effectiveness and added value of a force feedback hand rehabilitation robot combined with task-oriented training in stroke ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10772600/

Research Status and Prospect of Finger Rehabilitation ... In addition, the finger rehabilitation robot is also equipped with force sensors and angle sensors, which measure the strength of the fingers ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12265130/

Upper limb robotic rehabilitation following stroke: a systematic ... The results suggest that robotic rehabilitation does not result in clinically meaningful improvement in either upper limb capacity or ADL performance.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1052305721002159

Effects of a Soft Robotic Hand for Hand Rehabilitation in ... This research has shown the efficacy of soft robotic hand with flexion and extension assistive torque in chronic stroke rehabilitation.