RECRUITING

Telerehabilitation In The Home After Stroke

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this research study is to evaluate whether telerehabilitation targeting arm movement, when added to usual care, improves arm function and reduces global disability after stroke, compared to usual care alone. Patients with arm weakness due to stroke that happened in the past 90-150 days will be randomized into one of two groups: \[1\] TR and usual care; \[2\] usual care only (no TR), but people in the usual care group will be offered TR once the study is done. TR consists of 70 minutes/day of activities targeting arm function, 6 days a week for 6 weeks.

Official Title

Telerehabilitation In The Home After Stroke: A Randomized, Controlled, Assessor-Blind Clinical Trial

Quick Facts

Study Start:2025-08

Study Completion:2030-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06682429

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age 18-80 years at the time of randomization 2. The index stroke was radiologically verified, due to ischemia or intracerebral hemorrhage (ICH), and had time of onset 120±30 days prior to randomization 3. The stroke caused upper extremity deficits as defined by Action Research Arm Test score 18-44 (out of 57) at Baseline Visit 1 4. Box \& Block Test score with affected arm is ≥1 block in 60 seconds at Baseline Visit 1 5. Able to successfully perform all 3 rehabilitation exercise test examples (simple commands) at Baseline Visit 1 6. Informed consent and behavioral contract signed by the subject (i.e., no surrogate consent)	1. A major, active, coexistent neurological, psychiatric, or medical disease that reduces the likelihood that a subject will be able to comply with all study procedures 2. Unable or unwilling to perform study procedures/therapy, or expectation of noncompliance with study procedures/therapy, or expectation that subject cannot participate in all study visits 3. A diagnosis (apart from the index stroke) that substantially affects paretic arm function 4. Severe depression, defined as Geriatric Depression Scale Score \>10/15 at Baseline Visit 1 5. Significant cognitive impairment, defined as Montreal Cognitive Assessment score \<22 \[a lower score is permitted if due to aphasia and allowed by the site PI\] 6. Deficits in communication that interfere with reasonable study participation 7. Severe UE spasticity, defined as presence of contracture or modified Ashworth Scale score=4 in either biceps or pectoralis 8. Modified Rankin Scale score was \>2 prior to the index stroke 9. A new symptomatic stroke has occurred since the index stroke, or a separate stroke occurred within 30 days prior to the index stroke 10. Lacking visual acuity, with or without corrective lens, of 20/50 or better in at least one eye 11. Life expectancy \< 9 months 12. Pregnant; women of child-bearing potential must have a negative pregnancy test 13. Botulinum toxin to the paretic arm: received in the prior 3 months OR expected by the 8-Month Visit 14. Concurrent enrollment in another therapy-based investigational study where the duration of the investigational therapy's activity is likely to occur during the subject's participation in the study 15. Subject lacks sufficient English or Spanish to comply with study procedures and TR instructions 16. Expectation that subject will not have a single domicile address during the 6 weeks of therapy that is within 1.5-hr drive of the central study site \[this can be waived at the discretion of the site PI\] 17. Contraindication to MRI 18. On isolation precautions, e.g., due to active COVID-19

Inclusion Criteria

Exclusion Criteria

1. Age 18-80 years at the time of randomization
2. The index stroke was radiologically verified, due to ischemia or intracerebral hemorrhage (ICH), and had time of onset 120±30 days prior to randomization
3. The stroke caused upper extremity deficits as defined by Action Research Arm Test score 18-44 (out of 57) at Baseline Visit 1
4. Box \& Block Test score with affected arm is ≥1 block in 60 seconds at Baseline Visit 1
5. Able to successfully perform all 3 rehabilitation exercise test examples (simple commands) at Baseline Visit 1
6. Informed consent and behavioral contract signed by the subject (i.e., no surrogate consent)

1. A major, active, coexistent neurological, psychiatric, or medical disease that reduces the likelihood that a subject will be able to comply with all study procedures
2. Unable or unwilling to perform study procedures/therapy, or expectation of noncompliance with study procedures/therapy, or expectation that subject cannot participate in all study visits
3. A diagnosis (apart from the index stroke) that substantially affects paretic arm function
4. Severe depression, defined as Geriatric Depression Scale Score \>10/15 at Baseline Visit 1
5. Significant cognitive impairment, defined as Montreal Cognitive Assessment score \<22 \[a lower score is permitted if due to aphasia and allowed by the site PI\]
6. Deficits in communication that interfere with reasonable study participation
7. Severe UE spasticity, defined as presence of contracture or modified Ashworth Scale score=4 in either biceps or pectoralis
8. Modified Rankin Scale score was \>2 prior to the index stroke
9. A new symptomatic stroke has occurred since the index stroke, or a separate stroke occurred within 30 days prior to the index stroke
10. Lacking visual acuity, with or without corrective lens, of 20/50 or better in at least one eye
11. Life expectancy \< 9 months
12. Pregnant; women of child-bearing potential must have a negative pregnancy test
13. Botulinum toxin to the paretic arm: received in the prior 3 months OR expected by the 8-Month Visit
14. Concurrent enrollment in another therapy-based investigational study where the duration of the investigational therapy's activity is likely to occur during the subject's participation in the study
15. Subject lacks sufficient English or Spanish to comply with study procedures and TR instructions
16. Expectation that subject will not have a single domicile address during the 6 weeks of therapy that is within 1.5-hr drive of the central study site \[this can be waived at the discretion of the site PI\]
17. Contraindication to MRI
18. On isolation precautions, e.g., due to active COVID-19

Contacts and Locations

Study Contact

Steven Cramer, MD

CONTACT

424-522-7273

tr2trial@mednet.ucla.edu

Principal Investigator

Steven Cramer, MD

PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Study Locations (Sites)

University of California, Los Angeles

Los Angeles, California, 90095

United States

Casa Colina Hospital and Centers for Healthcare

Pomona, California, 91767

United States

Hillcrest Medical Center at UC San Diego Health

San Diego, California, 92103

United States

Jefferson Moss Rehabilitation Research Institute

Elkins Park, Pennsylvania, 19027

United States

University of Utah Health

Salt Lake City, Utah, 84132

United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

Steven Cramer, MD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08

Study Completion Date2030-06

Study Record Updates

Study Start Date2025-08

Study Completion Date2030-06

Terms related to this study

Keywords Provided by Researchers

stroke
rehabilitation
telehealth

Additional Relevant MeSH Terms

Stroke