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Clinical Trials/NCT07000019
NCT07000019Not yet recruitingNot Applicable

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

New York Medical College1 site in 1 country28 target enrollmentStarted: June 1, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
28
Locations
1
Primary Endpoint
Philadelphia Naming Test

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •Diagnosis or history of speech impairment prior to stroke
  • •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
  • •Condition limiting passive movement in the range of motion required for robotic therapy (e.g. fixed contracture)
  • •Any medical or psychiatric condition that may impact participation or compliance with study procedures or activities in the opinion of the investigator

Arms & Interventions

Combined aphasia and robot-assisted arm treatment

Experimental

Intervention: CARAT: combined aphasia and robot-assisted arm therapy (Behavioral)

Robot-assisted arm treatment

Active Comparator

Intervention: Robot-assisted arm therapy (Behavioral)

Outcomes

Primary Outcomes

Philadelphia Naming Test

Time Frame: Baseline to 1 week post-treatment

Fugl-Meyer Upper Extremity Motor Assessment

Time Frame: Baseline to 1 week post-treatment

Secondary Outcomes

  • Western Aphasia Battery-Revised Aphasia Quotient(Baseline to 4 weeks post-treatment)
  • Box and Blocks Test(Baseline to 1 and 4 weeks post-training)
  • Apraxia Battery for Adults(Baseline to 1 and 4 weeks post-training)
  • Stroke and Aphasia Quality of Life Scale-39(Baseline to 1 and 4 weeks post-training)
  • Apraxia of Speech Rating Scale(Baseline to 1 and 4 weeks post-training)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tomoko Kitago, MD

Assistant Professor of Neurology

New York Medical College

Study Sites (1)

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