Self-Administered Gaming and Exercise at Home (SAGEH)

Recruiting now · Not applicable

Conditions studied: Stroke, Hand Weakness

In brief

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.

Key facts

Study ID

NCT05929027

Run by

Johns Hopkins University

People needed

60

Starts

2023-09-28

Expected to finish

2027-12-01

Last updated by the study team

2025-07-18

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 21 years and over
• Stroke confirmed by CT or MRI within the previous 6 weeks.
• Arm and/or hand impairment induced by the stroke.
• Meet JSTTEP criteria and are enrolled in JSTTEP.
• Admitted to the Johns Hopkins Hospital (JHH) inpatient stroke service.
• Proficient in speaking and reading English.
• Willing and capable to contacted remotely for all necessary telemedicine contacts.
• No history of prior ischemic or hemorrhagic stroke with associated motor deficits (prior stroke with no upper limb motor symptoms is allowed)
• Ability to give informed consent.

You may not qualify if…

• Arm impairment that is too severe (FM-UE < 40) on day of baseline testing prior to beginning of the study.
• Recent Botox injection to upper limb (since stroke onset).
• 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).
• Terminal illness with life expectancy < 6 months.
• Inability to sit in a chair and perform hand exercises for 20 minutes at the time.
• Cognitive impairment, with score on Montreal Cognitive Assessment (MoCA) ≤ 20.
• Social and/or personal circumstances that prevent telemedicine follow-up.

Where it is running

• Johns Hopkin — Baltimore, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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