Clinical trial NCT07000019: Combined Aphasia and Robot-Assisted Arm Treatment for Chronic Stroke Survivors
Official title: Combined Aphasia and Robot-Assisted Arm Treatment for Chronic Stroke Survivors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Aphasia Following Cerebral Infarction
Hemiparesis After Stroke
Keywords: stroke, aphasia, hemiparesis, robotic
Lead sponsor: New York Medical College
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
name: New York University
First posted: 2025-05-31
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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:

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

Primary outcomes:
measure: Philadelphia Naming Test
timeFrame: Baseline to 1 week post-treatment
measure: Fugl-Meyer Upper Extremity Motor Assessment
timeFrame: Baseline to 1 week post-treatment
Secondary outcomes:
measure: Western Aphasia Battery-Revised Aphasia Quotient
timeFrame: Baseline to 4 weeks post-treatment
measure: Box and Blocks Test
timeFrame: Baseline to 1 and 4 weeks post-training
measure: Apraxia Battery for Adults
timeFrame: Baseline to 1 and 4 weeks post-training
measure: Stroke and Aphasia Quality of Life Scale-39
timeFrame: Baseline to 1 and 4 weeks post-training
measure: Apraxia of Speech Rating Scale
timeFrame: Baseline to 1 and 4 weeks post-training
Other outcomes:
measure: Arm kinematics
timeFrame: Baseline to 1 and 4 weeks post-training
measure: Arm vs. Non-Arm Naming
timeFrame: Baseline to 1 and 4 weeks post-training
Locations:
city: Valhalla
country: United States
facility: Westchester Medical Center / New York Medical College
state: New York
Study officials:
affiliation: Westchester Medical Center / New York Medical College
name: Tomoko Kitago, MD
role: PRINCIPAL_INVESTIGATOR
References: