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

Not Applicable

Not yet recruiting

• Conditions: Stroke; Aphasia Following Cerebral Infarction; Hemiparesis After Stroke

• Registration Number: NCT07000019
• Lead Sponsor: New York Medical College

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-23
• Study First Submitted QC: 2025-05-23
• Last Update Submitted: 2025-05-23
• Study First Posted: 2025-05-31
• Last Update Posted: 2025-05-31
• Study Start: 2025-06
• Primary Completion: 2027-10
• Study Completion: 2027-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Philadelphia Naming Test	Baseline to 1 week post-treatment
Fugl-Meyer Upper Extremity Motor Assessment	Baseline to 1 week post-treatment

Secondary Outcome Measures

Name	Time	Method
Box and Blocks Test	Baseline to 1 and 4 weeks post-training
Apraxia Battery for Adults	Baseline to 1 and 4 weeks post-training
Western Aphasia Battery-Revised Aphasia Quotient	Baseline to 4 weeks post-treatment
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

Trial Locations

Locations (1)

Westchester Medical Center / New York Medical College; 🇺🇸 Valhalla, New York, United States