Combined Aphasia and Arm Therapy for Stroke

(CARAT Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: New York Medical College

Disqualifiers: Speech impairment, Severe language/cognitive, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a program combining language and arm therapy, known as CARAT (combined aphasia and robot-assisted arm therapy), can enhance speaking and arm movement abilities in stroke survivors. The study will compare this combined treatment to therapy focusing solely on arm movement. It targets individuals who experienced a stroke affecting the left side of the brain at least six months ago, have difficulty speaking, and have some arm movement issues. Participants should have been right-handed before their stroke and speak only English. As an unphased trial, this study provides a unique opportunity to explore innovative therapies that could enhance recovery and improve quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this combined aphasia and robot-assisted arm therapy is safe for stroke patients?

Research has shown that robot-assisted therapy is generally safe for stroke patients. Studies have found that these therapies can help improve arm movement and language skills. In one study, participants improved their speech and movement without any major problems. Another study found that combining different therapies, such as robot-assisted therapy and direct stimulation, improved language in some patients and was safe to use. Overall, these treatments are considered safe and effective for stroke rehabilitation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CARAT treatment because it uniquely combines aphasia therapy with robot-assisted arm therapy for stroke recovery. Unlike traditional treatments that focus solely on speech or physical rehabilitation, this method integrates both, potentially enhancing the recovery of both speech and movement simultaneously. The use of robot-assisted technology is particularly intriguing as it offers precise, repetitive movement exercises, which can be more effective than manual therapy alone. By addressing both aphasia and motor skills in a coordinated manner, CARAT may offer a more comprehensive approach to stroke rehabilitation.

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

Studies have shown that using robots in therapy can help stroke patients improve motor skills and reduce pain. In this trial, participants will join different treatment arms. One arm will receive combined aphasia and robot-assisted arm therapy, which has led to greater improvements in both speaking and moving. Another arm will receive robot-assisted arm treatment alone. Research suggests that the combined approach significantly aids speech and movement recovery, offering a promising method for stroke rehabilitation. ^{1 3 6 7 8}

Who Is on the Research Team?

Tomoko Kitago, MD

Principal Investigator

Westchester Medical Center / New York Medical College

Are You a Good Fit for This Trial?

This trial is for chronic stroke survivors who have difficulty with language (aphasia) and arm movement. Participants should be stable post-stroke and able to follow the study procedures. Those with other neurological conditions or unable to commit to the treatment schedule are excluded.

Inclusion Criteria

Right-handed prior to stroke

Comprehension score above 4 on WAB-R

Documentation of signed Informed Consent by the study participant

Exclusion Criteria

Severely limited speech output (score below 2 on spontaneous speech portion of WAB-R)

Inability to perform screening tasks due to severe language and/or cognitive impairment

Any medical or psychiatric condition that may impact participation or compliance with study procedures or activities in the opinion of the investigator

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive combined aphasia and robot-assisted arm treatment to improve language and arm movements

8 weeks

Weekly 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

• CARAT: combined aphasia and robot-assisted arm therapy

Trial Overview The trial is testing a combined therapy called CARAT, which focuses on improving both language and arm function in stroke survivors, against a control group receiving only robot-assisted arm therapy.

How Is the Trial Designed?

Group I: Combined aphasia and robot-assisted arm treatment Experimental Treatment 1 Intervention

Group II: Robot-assisted arm treatment Active Control 1 Intervention

Who Is Running the Clinical Trial?

New York Medical College

Lead Sponsor

Trials

73

Recruited

8,700+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

New York University

Collaborator

Trials

249

Recruited

229,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6207995/

Robotic Arm Rehabilitation in Chronic Stroke Patients With ... Results: Overall, the individuals significantly improved on measures of motor speech production from pre-test to post-test. Of the subset who performed language ...

2. clinconnect.io clinconnect.io/trials/NCT07000019

Combined Aphasia and Robot-Assisted Arm Treatment for This clinical trial is testing a new treatment program that combines language therapy and robot-assisted arm exercises for people who have had a stroke. The ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999324008104

The Combined Effect of Robot-assisted Therapy and ... The findings indicate that RAT followed by ADL training is more effective than CRT followed by ADL training in motor improvement, SIS-HF, SIS-ADL, and QOL at ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT00372411

Robotic Assisted Upper-Limb Neurorehabilitation in Stroke ... This study will compare robotic training with usual care and intensive comparison therapy to attempt to improve upper extremity function. Detailed Description.

5. researchgate.net researchgate.net/profile/Ita-Saragih/publication/363666482_Efficacy_of_Robots-Assisted_Therapy_in_Patients_With_Stroke_A_Meta-analysis_Update/links/632975fe70cc936cd31fc492/Efficacy-of-Robots-Assisted-Therapy-in-Patients-With-Stroke-A-Meta-analysis-Update.pdf

Efficacy of Robots-Assisted Therapy in Patients With Stroke Conclusions: Robot-assisted therapy seems to improve the quality of mobility and reduce balance disturbances and pain for patients with stroke. These findings ...

6. journals.sagepub.com journals.sagepub.com/doi/abs/10.3233/RNN-2007-00347

Combined transcranial direct current stimulation and robot ... Unexpectedly, aphasia improved in 4 patients. Conclusions: These procedures are safe, and easy to use in a clinical setting. In future studies, patients should ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02747433

Robot-Assisted Therapy and Motor Learning: An Active ... The MAL has been widely used in stroke rehabilitation studies to measure self-reported amount and quality of paretic arm use during daily activities.

8. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.121.037260

Robot-Assisted Training as Self-Training for Upper-Limb ... This study aimed to examine whether robotic self-training improved upper-extremity function versus conventional self-training in mild-to-moderate hemiplegic ...