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Not yet recruitingNCT07000019CARATUpdated May 31, 2025

Combined Aphasia and Robot-Assisted Arm Treatment for Chronic Stroke Survivors

An interventional study of CARAT: combined aphasia and robot-assisted arm therapy and Robot-assisted arm therapy in Stroke, Aphasia Following Cerebral Infarction and Hemiparesis After Stroke, sponsored by New York Medical College. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-05-31.

Sponsored by New York Medical College · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

The goal of this clinical trial is to learn if a program that combines language and arm treatment can improve language and movement problems in people with chronic stroke. The mains questions it aims to answer are:

  • To determine the extent to which this combined treatment can improve language.
  • To determine the extent to which the combined treatment can improve arm movements.

Researchers will compare the effects of this combined treatment with treatment that targets arm movements alone.

02

Conditions studied

  • Stroke
  • Aphasia Following Cerebral Infarction
  • Hemiparesis After Stroke

Keywords

  • stroke, aphasia, hemiparesis, robotic
03

In context

Stroke

7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.

This study's planned enrollment of 28 is below the median of 50 across 5,482 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

New York Medical College is the lead sponsor of 71 studies on the registry; 24 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female patients between 18-90 years of age.
  2. Right-handed prior to stroke
  3. English-speaking (monolingual)
  4. History of single left-hemisphere stroke at least 6 months prior to enrollment
  5. Presence of aphasia and naming deficits on Western Aphasia Battery (WAB-R)
  6. Comprehension score above 4 on WAB-R
  7. Unilateral upper limb paresis (Fugl-Meyer Upper Extremity score \<56)
  8. Documentation of signed Informed Consent by the study participant.

Exclusion criteria

Exclusion Criteria:

  1. Diagnosis or history of speech impairment prior to stroke
  2. Severely limited speech output (score below 2 on spontaneous speech portion of WAB-R)
  3. Inability to perform screening tasks due to severe language and/or cognitive impairment
  4. Condition limiting passive movement in the range of motion required for robotic therapy (e.g. fixed contracture)
  5. Any medical or psychiatric condition that may impact participation or compliance with study procedures or activities in the opinion of the investigator
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
28 participants (estimated)

Study arms

  • Experimental
    Combined aphasia and robot-assisted arm treatment

    Behavioral: CARAT: combined aphasia and robot-assisted arm therapy

  • Active comparator
    Robot-assisted arm treatment

    Behavioral: Robot-assisted arm therapy

Interventions

  • BehavioralCARAT: combined aphasia and robot-assisted arm therapy

    Participants will receive 18 sessions of robot-assisted arm therapy combined with a standardized picture-word verification therapy task with the goal of improving language and arm movements.

  • BehavioralRobot-assisted arm therapy

    Participants will receive 18 sessions of robot-assisted arm therapy with the goal of improving arm movements.

06

What researchers measure

Primary outcomes

  1. Philadelphia Naming Test

    Time frame: Baseline to 1 week post-treatment

  2. Fugl-Meyer Upper Extremity Motor Assessment

    Time frame: Baseline to 1 week post-treatment

Secondary outcomes

  1. Western Aphasia Battery-Revised Aphasia Quotient

    Time frame: Baseline to 4 weeks post-treatment

  2. Box and Blocks Test

    Time frame: Baseline to 1 and 4 weeks post-training

  3. Apraxia Battery for Adults

    Time frame: Baseline to 1 and 4 weeks post-training

  4. Stroke and Aphasia Quality of Life Scale-39

    Time frame: Baseline to 1 and 4 weeks post-training

  5. Apraxia of Speech Rating Scale

    Time frame: Baseline to 1 and 4 weeks post-training

Other outcomes

  1. Arm kinematics

    Time frame: Baseline to 1 and 4 weeks post-training

  2. Arm vs. Non-Arm Naming

    Time frame: Baseline to 1 and 4 weeks post-training

07

Study locations

1 site
  • Westchester Medical Center / New York Medical College
    Valhalla, New York 10595, United States
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07000019
Lead sponsor
New York Medical College
Responsible party
Tomoko Kitago, MD (Assistant Professor of Neurology, New York Medical College) — Principal investigator
First posted
May 31, 2025
Start date
Jun 2025 (estimated)
Primary completion
Oct 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
May 31, 2025

Study contacts

Tomoko Kitago, MD
principal investigator · Westchester Medical Center / New York Medical College

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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