NCT07661849

Brief Summary

This study evaluates whether a home-based telerehabilitation program (tele-CPASS) is as effective as an in-person rehabilitation program (CPASS) for improving arm and hand function after stroke. Stroke often leads to long-term difficulty using the affected arm in daily activities, and access to in-person therapy can be limited. This study aims to determine whether therapy delivered remotely can provide similar benefits to standard in-clinic care. Participants who recently experienced a stroke will be randomly assigned to receive 20 hours of upper extremity rehabilitation therapy either in person or through a telehealth platform. Both groups will receive the same type and amount of therapy focused on practicing meaningful, patient-selected daily activities. Participants will complete assessments before treatment, immediately after treatment, and at 6 and 12 months to measure recovery of arm function, real-world arm use, and participation in daily life. The results of this study will help determine whether telerehabilitation can improve access to effective stroke recovery interventions while maintaining clinical effectiveness comparable to in-person therapy.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
38mo left

Started Sep 2025

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Sep 2025Aug 2029

Study Start

First participant enrolled

September 1, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 22, 2026

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2029

Last Updated

June 22, 2026

Status Verified

June 1, 2026

Enrollment Period

3 years

First QC Date

June 11, 2026

Last Update Submit

June 16, 2026

Conditions

Keywords

TelerehabilitationTelehealthStroke rehabilitationUpper extremity recoveryMotor recoveryCritical period plasticityWearable sensorsAccelerometry

Outcome Measures

Primary Outcomes (1)

  • Upper Extremity Motor Function (Action Research Arm Test [ARAT])

    The Action Research Arm Test (ARAT) is a standardized, performance-based measure of upper extremity motor function. It assesses grasp, grip, pinch, and gross movement using a series of functional tasks. Scores range from 0 to 57, with higher scores indicating better motor function.

    Baseline, 3 months, 6 months, and 12 months

Secondary Outcomes (2)

  • Functional Upper Extremity Use (Accelerometry)

    Baseline, 3 months, 6 months, and 12 months

  • Social Participation (Stroke Impact Scale)

    Baseline, 3 months, 6 months, and 12 months

Study Arms (2)

Tele-CPASS

EXPERIMENTAL

Participants receive 20 hours of therapist-guided upper extremity motor rehabilitation delivered remotely in the home using a telehealth platform. Therapy is individualized based on participant-prioritized activities and focuses on repetitive practice of meaningful daily tasks to improve arm and hand function after stroke.

Behavioral: Tele-CPASS

In-person CPASS

ACTIVE COMPARATOR

Participants receive 20 hours of therapist-guided upper extremity motor rehabilitation delivered in person in the clinic. Therapy is individualized based on participant-prioritized activities and focuses on repetitive practice of meaningful daily tasks to improve arm and hand function after stroke.

Behavioral: In-person CPASS therapy

Interventions

Tele-CPASSBEHAVIORAL

Intervention 1: Tele-CPASS Tele-CPASS is a home-based telerehabilitation intervention consisting of 20 hours of therapist-guided, task-specific upper extremity motor training delivered remotely using a telehealth platform for individuals with stroke. Therapy is individualized based on participant-selected functional goals and focuses on repetitive practice of meaningful daily activities to improve arm and hand function after stroke. Participants complete sessions in their home environment with real-time therapist guidance and may be provided with equipment and technology needed to support remote delivery.

Tele-CPASS

Intervention 2: In-person CPASS therapy In-person CPASS is a clinic-based rehabilitation intervention consisting of 20 hours of therapist-guided, task-specific upper extremity motor training delivered face-to-face. Therapy is individualized based on participant-selected functional goals and focuses on repetitive practice of meaningful daily activities to improve arm and hand function after stroke. Sessions are conducted in a clinical setting under direct supervision of a therapist.

In-person CPASS

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 21 years or older
  • Neuroimaging-confirmed stroke within 40 days prior to enrollment
  • Persistent hemiparesis resulting in impaired upper extremity function, defined by a score of 0 to 3 on the NIH Stroke Scale motor arm item
  • Able to participate in all study-related activities, including 1-year follow-up
  • Short Blessed Memory Orientation and Concentration Scale score less than 8
  • Able to follow 2-step commands
  • Montreal Cognitive Assessment (MoCA) score greater than 25
  • No upper extremity injury or condition that limited upper extremity use prior to the stroke

You may not qualify if:

  • Inability to provide informed consent
  • Persistent disabling neurologic condition, such as multiple sclerosis, Parkinsonism, amyotrophic lateral sclerosis, or dementia requiring medication
  • Clinically significant fluctuations in mental status within 72 hours prior to randomization
  • Active psychosis, psychosis within the prior 2 years, active substance abuse, or prior substance abuse
  • Dense sensory loss, defined by a score of 3 or 4 on the NIH Stroke Scale sensory item
  • Ataxia out of proportion to weakness in the affected arm, defined by a score greater than 1 on the NIH Stroke Scale ataxia item
  • Not expected to survive 12 months because of other illnesses
  • Pregnancy
  • Severe aphasia
  • Receipt of botulinum toxin or expectation of receiving botulinum toxin during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Rehabilitation Sciences Complex, University of Texas at El Paso, 3333 N Mesa St, El Paso, TX 79902

El Paso, Texas, 79902, United States

RECRUITING

Texas Tech University Health Sciences Center El Paso - Neurology Clinic

El Paso, Texas, 79905, United States

RECRUITING

University Medical Center of El Paso - Rehabilitation Services

El Paso, Texas, 79905, United States

RECRUITING

Related Publications (3)

  • Barth J, Geed S, Mitchell A, Brady KP, Giannetti ML, Dromerick AW, Edwards DF. The Critical Period After Stroke Study (CPASS) Upper Extremity Treatment Protocol. Arch Rehabil Res Clin Transl. 2023 Jul 24;5(3):100282. doi: 10.1016/j.arrct.2023.100282. eCollection 2023 Sep.

    PMID: 37744191BACKGROUND
  • Dromerick AW, Geed S, Barth J, Brady K, Giannetti ML, Mitchell A, Edwardson MA, Tan MT, Zhou Y, Newport EL, Edwards DF. Critical Period After Stroke Study (CPASS): A phase II clinical trial testing an optimal time for motor recovery after stroke in humans. Proc Natl Acad Sci U S A. 2021 Sep 28;118(39):e2026676118. doi: 10.1073/pnas.2026676118.

    PMID: 34544853BACKGROUND
  • Nieto EM, Lujan E, Mendoza CA, Arriaga Y, Fierro C, Tran T, Chang LC, Gurovich AN, Lum PS, Geed S. Accelerometry and the Capacity-Performance Gap: Case Series Report in Upper-Extremity Motor Impairment Assessment Post-Stroke. Bioengineering (Basel). 2025 Jun 4;12(6):615. doi: 10.3390/bioengineering12060615.

    PMID: 40564431BACKGROUND

Related Links

MeSH Terms

Conditions

StrokeParesis

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dr. Shashwati Geed, PT, PhD

    Department of Physical Therapy and Movement Sciences, University of Texas at El Paso

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Shashwati Geed, PT, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2026

First Posted

June 22, 2026

Study Start

September 1, 2025

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

August 31, 2029

Last Updated

June 22, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because this is a small, single-site rehabilitation trial involving individuals recovering from stroke, and the dataset includes potentially identifiable clinical, functional, accelerometry, and video-derived movement data. The protocol includes video recordings of upper extremity activity scripts and therapy sessions, which are used for frame-by-frame annotation and machine-learning classification of functional arm use. Although study data are coded with randomly generated participant IDs and identifiers are stored separately, the combination of clinical characteristics, timing post-stroke, functional outcomes, accelerometry, and video-derived data may increase the risk of deductive identification. Deidentified aggregate results may be shared through publications and presentations.

Locations