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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess how the Rehabilitation Technologies for Hand and Arm (R3THA) device can be used for rehabilitation of people with stroke. the study will evaluate the feasibility of R3THA as outpatient telerehabilitation administered by trained clinicians to individuals with 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.

What data supports the effectiveness of the treatment R3THA for stroke rehabilitation?

Research shows that intensive rehabilitation therapy, especially when started early, can improve outcomes for stroke patients. Interactive, motion capture-based rehabilitation has been found to be effective in improving physical function in stroke patients, suggesting that similar innovative therapies like R3THA might also be beneficial. ^{1 2 3 4 5}

Research Team

Kiran Karunakaran, PhD

Principal Investigator

Kessler Foundation

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Dose and setting of rehabilitation received after stroke in Queensland, Australia: a prospective cohort study. [2022]

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

Telerehabilitation Initiated Early in Post-Stroke Recovery: A Feasibility Study. [2023]

3. United States 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. [2022]

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

Admission in Neurorehabilitation and Association with Functional Outcomes after Stroke in France: A Nation-Wide Study, 2010-2014. [2019]

5. England 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. [2018]