Combined Aphasia and Robot-Assisted Arm Treatment for Chronic Stroke Survivors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CARAT: combined aphasia and robot-assisted arm therapy, Robot-assisted arm therapy.
- Who it may be relevant to
- Registry conditions: Stroke, Aphasia Following Cerebral Infarction, Hemiparesis After Stroke. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral CARAT: 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. - Behavioral Robot-assisted arm therapy
Participants will receive 18 sessions of robot-assisted arm therapy with the goal of improving arm movements.
Primary outcome measures
- 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 outcome measures (5)
- Western Aphasia Battery-Revised Aphasia Quotient [Time frame: Baseline to 4 weeks post-treatment]
- Box and Blocks Test [Time frame: Baseline to 1 and 4 weeks post-training]
- Apraxia Battery for Adults [Time frame: Baseline to 1 and 4 weeks post-training]
- Stroke and Aphasia Quality of Life Scale-39 [Time frame: Baseline to 1 and 4 weeks post-training]
- Apraxia of Speech Rating Scale [Time frame: Baseline to 1 and 4 weeks post-training]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Westchester Medical Center / New York Medical College — Valhalla
Identifiers
NCT: NCT07000019 · NYMC-25470 · R21DC019955