ClinicalTrials.gg
RecruitingNCT07661849Updated Jun 22, 2026

Efficacy of Tele-CPASS Compared to In-person CPASS Therapy for Upper Extremity Motor Recovery

An interventional study of Tele-CPASS and In-person CPASS therapy in Stroke, Hemiparesis and Upper Extremity Impairments, sponsored by University of Texas, El Paso. Recruiting at 3 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-06-22.

Sponsored by University of Texas, El Paso · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Sep 2025, registered Jun 2026).
  • Started Sep 2025; still recruiting 1 year 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study 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.

Read the detailed description

Stroke is a leading cause of long-term disability, with a substantial proportion of survivors experiencing persistent upper extremity impairment that limits independence in daily activities. While rehabilitation can improve outcomes, access to consistent, high-dose therapy remains a major barrier, particularly in the early months after stroke when recovery potential is highest. The Critical Periods After Stroke Study (CPASS) previously demonstrated that 20 hours of intensive, task-specific upper extremity training delivered within the first six months after stroke leads to clinically meaningful improvements in motor function compared to standard care.

Despite this evidence, many patients face challenges accessing in-person outpatient rehabilitation due to transportation limitations, cost, and geographic barriers. Telerehabilitation offers a potential solution by enabling delivery of structured therapy in the home environment. Prior studies suggest that home-based rehabilitation can achieve outcomes comparable to in-clinic care, while increasing accessibility and adherence. However, the efficacy of a telerehabilitation version of CPASS (tele-CPASS) relative to the established in-person CPASS intervention has not been rigorously tested.

This study is a randomized, controlled, parallel-group trial designed to evaluate whether tele-CPASS is comparable in efficacy to in-person CPASS for improving upper extremity recovery after stroke. Participants will be enrolled in the early post-stroke period and randomly assigned to one of two groups: (1) in-person CPASS delivered in a clinical setting, or (2) tele-CPASS delivered remotely in the participant's home using a secure telehealth platform. Both groups will receive the same total dose (20 hours) of therapist-guided, task-specific training over approximately 2-3 weeks. Therapy is individualized and based on patient-prioritized functional goals, emphasizing repetitive practice of meaningful daily activities.

Study procedures include baseline assessments followed by post-intervention and longitudinal follow-up assessments. In addition to standardized clinical evaluations, this study incorporates objective measurement of real-world arm use using wrist-worn accelerometers. These devices capture continuous movement data during daily life, allowing quantification of functional upper extremity use outside the clinical setting. A structured activity protocol performed in the laboratory and at home, combined with video annotation and machine learning methods, will be used to classify functional versus non-functional arm movements and enhance the ecological validity of outcome measurement.

The trial uses a non-inferiority framework to determine whether outcomes achieved with tele-CPASS are not meaningfully worse than those achieved with in-person CPASS. This approach is appropriate given prior evidence supporting the efficacy of the in-person intervention. Demonstrating comparable effectiveness would support tele-CPASS as a scalable and accessible model for delivering high-intensity stroke rehabilitation.

By directly comparing remote and in-person delivery of an evidence-based intervention, this study addresses a critical gap in stroke rehabilitation. If successful, tele-CPASS may expand access to effective therapy, reduce barriers to care, and inform future models of rehabilitation delivery that integrate clinic-based and home-based approaches.

02

Conditions studied

  • Stroke
  • Hemiparesis
  • Upper Extremity Impairments
  • Stroke Rehabilitation

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Keywords

  • Telerehabilitation
  • Telehealth
  • Stroke rehabilitation
  • Upper extremity recovery
  • Motor recovery
  • Critical period plasticity
  • Wearable sensors
  • Accelerometry
03

In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's planned enrollment of 42 is below the median of 49 across 6,024 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

University of Texas, El Paso is the lead sponsor of 21 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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
  • (MoCA) score greater than 25
  • No upper extremity injury or condition that limited upper extremity use prior to the stroke

Exclusion criteria

Exclusion Criteria:

  • Inability to provide
  • Persistent disabling neurologic condition, such as multiple sclerosis, Parkinsonism, amyotrophic lateral sclerosis, or dementia requiring medication
  • 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
42 participants (estimated)

Study arms

  • Experimental
    Tele-CPASS

    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

  • Active comparator
    In-person CPASS

    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

  • BehavioralTele-CPASS

    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.

  • BehavioralIn-person CPASS therapy

    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.

06

What researchers measure

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.

    Time frame: Baseline, 3 months, 6 months, and 12 months

Secondary outcomes

  1. Functional Upper Extremity Use (Accelerometry)

    Upper extremity activity is measured using wrist-worn accelerometers on both arms. Data are processed using validated ML algorithms to quantify the amount of functional use of the affected upper extremity during daily activities in home and community environments.

    Time frame: Baseline, 3 months, 6 months, and 12 months

  2. Social Participation (Stroke Impact Scale)

    The Stroke Impact Scale (SIS) is a patient-reported outcome measure assessing perceived participation in social and community activities. Scores range from 0 to 100, with higher scores indicating better participation.

    Time frame: Baseline, 3 months, 6 months, and 12 months

07

Study locations

3 of 3 sites recruiting
  • 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
    • Dr. Paisith Piriyawat, Medical Director, Rehabilitation Services, UMC-EP, MD · ContactPaisith.Piriyawat@ttuhsc.edu · 915-215-5900
    • Israel Alba, MBA, CCRP · Contact915-215-4616
  • University Medical Center of El Paso - Rehabilitation Services
    El Paso, Texas 79905, United States
    Recruiting
08

References and documents

Publications

  • 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. PubMed 37744191 ↗
  • 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. PubMed 34544853 ↗
  • 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. PubMed 40564431 ↗

Related links

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07661849
Lead sponsor
University of Texas, El Paso
Collaborators
Texas Tech University Health Sciences Center, El Paso, The Catholic University of America
Responsible party
Sponsor
First posted
Jun 22, 2026
Start date
Sep 1, 2025
Primary completion
Aug 31, 2028 (estimated)
Completion
Aug 31, 2029 (estimated)
Last update
Jun 22, 2026

Study contacts

Dr. Shashwati Geed, PT, PhD
Contact
sgeed@utep.edu
915-747-7289
Dr. Shashwati Geed, PT, PhD
principal investigator · Department of Physical Therapy and Movement Sciences, University of Texas at El Paso

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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