Combined Aphasia and Robot-Assisted Arm Treatment for Chr... | NCT07000019

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

NCT07000019

Sponsor

New York Medical College

Status

Not yet recruiting

Last Update Posted

May 31, 2025Actual

Enrollment

28Estimated

Phase

Not Applicable

Conditions

Stroke
Aphasia Following Cerebral Infarction
Hemiparesis After Stroke

Interventions

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

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R21DC019955	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2025Estimated

Primary Completion Date

Oct 2027Estimated

Completion Date

Nov 2027Estimated

First Submitted Date

May 23, 2025

First Submission Date that Met QC Criteria

May 23, 2025

First Posted Date

May 31, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 23, 2025

Last Update Posted Date

May 31, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tomoko Kitago, MD, Assistant Professor of Neurology, New York Medical CollegePrincipal Investigator

Lead Sponsor

New York Medical CollegeOTHER

Collaborators

Name	Class
National Institute on Deafness and Other Communication Disorders (NIDCD)	NIH
New York University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Combined aphasia and robot-assisted arm treatment	Experimental		Behavioral: CARAT: combined aphasia and robot-assisted arm therapy
Robot-assisted arm treatment	Active Comparator		Behavioral: Robot-assisted arm therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CARAT: combined aphasia and robot-assisted arm therapy	Behavioral	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Philadelphia Naming Test		Baseline to 1 week post-treatment
Fugl-Meyer Upper Extremity Motor Assessment		Baseline to 1 week post-treatment

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Measure	Description	Time Frame
Arm kinematics		Baseline to 1 and 4 weeks post-training
Arm vs. Non-Arm Naming		Baseline to 1 and 4 weeks post-training

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tomoko Kitago, MD	Westchester Medical Center / New York Medical College	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Westchester Medical Center / New York Medical College		Valhalla	New York	10595	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke
D001037	Aphasia
D010291	Paresis

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided