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Search / Trial NCT05929027

Self-Administered Gaming and Exercise at Home (SAGEH)

Launched by JOHNS HOPKINS UNIVERSITY · Jun 23, 2023

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Stroke Stroke Recovery Hand Weakness Video Game

ClinConnect Summary

The SAGEH trial is studying the effects of a new hand therapy program for people who have had a stroke and are experiencing weakness in their hands. The goal is to see if adding self-administered hand exercises, which patients can do at home, improves hand function compared to the usual therapy provided in outpatient visits. This is important because many stroke survivors struggle with using their hands effectively, and early recovery is crucial for regaining skills. The trial aims to provide more opportunities for practice, helping patients recover better.

To participate in this study, you need to be at least 21 years old and have had a stroke confirmed by a medical scan within the last six weeks. You should also have some weakness in your arm or hand due to the stroke and be able to read and speak English. Participants will be involved in telemedicine follow-ups, which means you can connect with the research team remotely. If you join the trial, you will receive guidance on doing exercises at home, and the team will track your progress to see how well the therapy works.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Age 21 years and over
  • 2. Stroke confirmed by CT or MRI within the previous 6 weeks.
  • 3. Arm and/or hand impairment induced by the stroke.
  • 4. Meet JSTTEP criteria and are enrolled in JSTTEP.
  • 5. Admitted to the Johns Hopkins Hospital (JHH) inpatient stroke service.
  • 6. Proficient in speaking and reading English.
  • 7. Willing and capable to contacted remotely for all necessary telemedicine contacts.
  • 8. No history of prior ischemic or hemorrhagic stroke with associated motor deficits (prior stroke with no upper limb motor symptoms is allowed)
  • 9. Ability to give informed consent.
  • Exclusion Criteria:
  • 1. Arm impairment that is too severe (FM-UE \< 40) on day of baseline testing prior to beginning of the study.
  • 2. Recent Botox injection to upper limb (since stroke onset).
  • 3. History of physical or neurological condition that interferes with study procedures or assessment of motor function (e.g. severe arthritis, severe neuropathy, Parkinson's disease).
  • 4. Terminal illness with life expectancy \< 6 months.
  • 5. Inability to sit in a chair and perform hand exercises for 20 minutes at the time.
  • 6. Cognitive impairment, with score on Montreal Cognitive Assessment (MoCA) ≤ 20.
  • 7. Social and/or personal circumstances that prevent telemedicine follow-up.

About Johns Hopkins University

Johns Hopkins University, a prestigious research institution located in Baltimore, Maryland, is renowned for its commitment to advancing medical science and public health through innovative clinical trials. With a rich history of groundbreaking research and a multidisciplinary approach, the university's clinical trial initiatives focus on translating scientific discoveries into effective treatments and interventions. Leveraging state-of-the-art facilities and a collaborative network of experts, Johns Hopkins University conducts rigorous clinical studies that aim to improve patient outcomes and address critical health challenges. Its dedication to ethical standards and participant safety underscores its role as a leader in clinical research.

Locations

Baltimore, Maryland, United States

Patients applied

0 patients applied

Trial Officials

Steven R Zeiler, M.D, Ph.D.

Principal Investigator

Johns Hopkins University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported