RECRUITING

Self-Administered Gaming and Exercise at Home (SAGEH)

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

This study aims at comparing manual function outcomes between the standard of care and additional self-administered hand therapy after stroke. Strokes are common neurological injuries, and although rates of survival have increased in recent decades, survivors often continue to experience deficiencies in hand dexterity and bimanual function. Most motor recovery takes place within the first 3 months after a stroke. This initial period is necessary for stabilizing the patient but also provides different opportunities to foster motor recovery. Functional gains, including instances after the post-acute period, have been observed after regular and frequent (high dosage) therapy, suggesting that recovery is likely influenced by practice-driven sensorimotor learning. These findings motivate the implementation of daily therapeutic regimes beyond post-stroke hospitalization and basic motor function, aiming instead at addressing overlooked deficiencies in manipulation and bimanual coordination. While some hand therapy is often provided during outpatient therapy visits (the standard of care), self-administered sessions play a large role in implementing additional daily therapy. As a result, the investigators are interested in both the implementation of self-administered regimes and measuring clinical outcomes with and without self-administered therapy.

Official Title

Self-Administered Gaming and Exercise at Home (SAGEH)

Quick Facts

Study Start:2023-09-28
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05929027

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

Contacts and Locations

Study Contact

Steven R. Zeiler, M.D., Ph.D.
CONTACT
3035207404
sz@jhmi.edu
Arnold Gomez, Ph.D.
CONTACT
adgomez@jhu.edu

Principal Investigator

Steven R Zeiler, M.D, Ph.D.
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

Johns Hopkin
Baltimore, Maryland, 21287-6953
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Steven R Zeiler, M.D, Ph.D., PRINCIPAL_INVESTIGATOR, Johns Hopkins University

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 Date2023-09-28
Study Completion Date2025-12

Study Record Updates

Study Start Date2023-09-28
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • stroke
  • stroke recovery
  • hand weakness
  • video game

Additional Relevant MeSH Terms

  • Stroke
  • Hand Weakness