Efficacy of Tele-CPASS Compared to In-person CPASS Therapy for Upper Extremity Motor Recovery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorUniversity of Texas, El Paso
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Tele-CPASS
BehavioralIntervention 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.
In-person CPASS therapy
BehavioralIntervention 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.
Treatment groups
42 Participants
are divided into 2 treatment groupsGroup A: Tele-CPASSExperimental treatment 1 intervention
Group B: In-person CPASSActive comparator 1 intervention
Trial outcomes
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 monthsSecondary 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 months2
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Texas, El Paso
Lead sponsor
Texas Tech University Health Sciences Center, El Paso
Collaborator
The Catholic University of America
Collaborator
Source ClinicalTrials.gov