R3THA for Stroke Rehabilitation

(RETHA Trial)

Overseen By Kiran Karunakaran, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kessler Foundation

Disqualifiers: Severe spasticity, Thinking problems, Spatial neglect, Receptive aphasia, Severe arthritis, others

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

Compensation: Varies

Number of Visits: 7

Duration: 5 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called R3THA to aid in recovering hand and arm movements after a stroke. The goal is to determine if using this device at home, with online guidance from a therapist, is practical and effective. Participants perform exercises through video games over several sessions. Individuals who have had a stroke, can move their arms and hands enough to play these games, and are comfortable using a computer might be suitable candidates.

As an unphased trial, this study provides a unique opportunity to contribute to innovative research and potentially enhance recovery methods for stroke patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the R3THA device is safe for stroke rehabilitation?

A previous study on the R3THA device for stroke recovery reported no harmful effects during therapy, indicating the device's safety for stroke patients. Telerehabilitation, or therapy through online sessions, has also proven safe for stroke survivors, even in early recovery stages. The R3THA device has been well-received by patients, making it a promising option for those seeking to regain hand and arm movement after a stroke. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about R3THA for stroke rehabilitation because it offers a unique approach through telerehabilitation. Unlike traditional in-person therapy sessions, R3THA allows participants to engage in hand and arm exercises remotely under the guidance of trained therapists. This method increases accessibility, making it easier for stroke survivors to receive consistent rehabilitation without the need for frequent travel to therapy centers. Additionally, the flexibility of remote sessions may enhance patient adherence and outcomes, potentially accelerating recovery.

What evidence suggests that the R3THA device is effective for stroke rehabilitation?

Research has shown that the R3THA device, which participants in this trial will use, can greatly improve arm movement in stroke patients. In a previous study, participants using R3THA improved by an average of 18.1 points on a test measuring arm and hand movement abilities. The R3THA system uses machine learning, a type of artificial intelligence, to customize exercises for each person, enhancing rehabilitation effectiveness. This method includes engaging exercise games designed to aid in recovering hand and arm functions after a stroke. These promising results suggest that R3THA could be a valuable tool in stroke rehabilitation. ^{1 2 3 6 7}

Who Is on the Research Team?

Kiran Karunakaran, PhD

Principal Investigator

Kessler Foundation

Are You a Good Fit for This Trial?

This trial is for individuals who have had a stroke and are in need of hand and arm rehabilitation. Participants will use the R3THA device as part of their outpatient therapy, guided by trained clinicians through telerehabilitation.

Inclusion Criteria

I can use my arms and hands to play video games.

I am between 20 and 80 years old.

Must have internet access at home

Exclusion Criteria

I have severe muscle spasms or stiffness in my arm that limits movement.

I have trouble thinking or following instructions.

I struggle to notice things on one side of a computer screen.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive R3THA telerehabilitation for hand and arm exercises

5 weeks

7 training sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• R3THA

Trial Overview The study is testing the R3THA device's effectiveness when used remotely to rehabilitate the hand and arm after a stroke. It aims to determine if this method is feasible for patients as they recover at home.

How Is the Trial Designed?

Group I: Stroke Experimental Treatment 1 Intervention

The study will enroll up to 10 participants with stroke who will be paired with trained therapists to receive R3THA telerehabilitation. The participants with stroke will participate in 7 training sessions. The training includes hand and arm exercises.

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

Published Research Related to This Trial

In a study of 504 stroke survivors, those who received inpatient rehabilitation had significantly more therapy time (median 29 hours) compared to community-based rehabilitation (median 6 hours), which was linked to better functional outcomes.

Patients who underwent inpatient rehabilitation were 3.6 times more likely to show improvement in their modified Rankin Scale scores compared to those who did not receive rehabilitation, highlighting the importance of intensive therapy in recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose and setting of rehabilitation received after stroke in Queensland, Australia: a prospective cohort study. Grimley, RS., Rosbergen, IC., Gustafsson, L., et al.[2022]

Between 2010 and 2014, the rate of patients admitted to neurological rehabilitation units (NRU) after a stroke increased, leading to a 4% rise in home return rates and a 7% increase in inpatient survival rates.

Patients admitted to NRUs had significantly better outcomes, with a 76% higher chance of functional gain, a 38% higher likelihood of returning home, and a 215% greater chance of surviving their hospital stay compared to those not admitted to NRUs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Admission in Neurorehabilitation and Association with Functional Outcomes after Stroke in France: A Nation-Wide Study, 2010-2014. Gabet, A., de Peretti, C., Woimant, F., et al.[2019]

A telerehabilitation (TR) program for stroke patients was found to be feasible and safe, with 100% compliance and 93% patient satisfaction among 16 participants who completed the intervention.

Participants showed significant improvements in arm motor function, with an average increase of 18.1 points on the Upper Extremity Fugl-Meyer score after 36 sessions, indicating that TR can effectively enhance rehabilitation outcomes when combined with usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telerehabilitation Initiated Early in Post-Stroke Recovery: A Feasibility Study. Edwards, D., Kumar, S., Brinkman, L., et al.[2023]

Younger and less disabled stroke patients tend to have better survival rates and outcomes, while those with dementia or pressure ulcers at admission face worse prognoses.

Starting rehabilitation within 7 days after a stroke significantly improves long-term outcomes compared to starting after 15 days or more, highlighting the importance of early intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early and long-term outcome of rehabilitation in stroke patients: the role of patient characteristics, time of initiation, and duration of interventions. Musicco, M., Emberti, L., Nappi, G., et al.[2022]

In a randomized controlled trial involving 73 stroke patients, both interactive motion capture rehabilitation and usual care showed similar improvements in standing balance and other physical functions, indicating that the new technology is as effective as traditional methods.

The study found no adverse events during therapy, suggesting that the interactive rehabilitation approach is safe for patients recovering from stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of interactive, motion capture-based rehabilitation on functional outcomes in an inpatient stroke population: a randomized controlled trial. Cannell, J., Jovic, E., Rathjen, A., et al.[2018]

Citations

1. withpower.com withpower.com/trial/phase-stroke-2-2024-1d9cd

R3THA for Stroke Rehabilitation (RETHA Trial) Participants showed significant improvements in arm motor function, with an average increase of 18.1 points on the Upper Extremity Fugl-Meyer score after 36 ...

2. sbir.gov sbir.gov/portfolio/1692485

Company SBIR Phase II: A machine learning-driven telerehabilitation solution designed to promote the personalized recovery of hand and arm functions post stroke.

3. research.rutgers.edu research.rutgers.edu/news/rutgers-startup-neurotechr3-announces-research-collaboration-kessler-foundation

Rutgers Startup NeuroTechR3 Announces ... R3THA is a neurorehabilitation system designed to improve hand and arm function through engaging, machine learning-enabled exergames, which are ...

4. neurotechr3.com neurotechr3.com/research/

Research Research into stroke, cerebral palsy, and gamified rehabilitation. Impact of stroke. Stroke is a leading cause of long-term disability.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10080366/

Telerehabilitation Initiated Early in Post-Stroke Recovery We have demonstrated that our TR intervention previously shown to be effective in the late subacute to chronic stage, is now feasible and safe in early recovery ...

6. jmir.org jmir.org/2018/10/e10867/

Telerehabilitation for Stroke Survivors: Systematic Review ... Telerehabilitation can be a suitable alternative to usual rehabilitation care in poststroke patients, especially in remote or underserved areas.

7. preprints.org preprints.org/manuscript/202406.0335/v1/download

Validation of the Kinematic Assessment Protocol Used in ... Kinematic measurements from R3THA-AP have demonstrated clinically acceptable levels of reliability as well moderate to strong correlations with ...