NCT05929027Recruiting
Self-Administered Gaming and Exercise at Home (SAGEH)
Source: ClinicalTrials.gov · Last updated 11 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 23 Jun 2023
- Start date
- 28 Sept 2023
- Primary completion date
- Jun 2027
- Lead sponsor
- Johns Hopkins University
- Diseases
- Stroke
- NCT number
- NCT05929027
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 28 Sept 2023 to the primary completion date, Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Arm impairment that is too severe (FM-UE \< 40) on day of baseline testing prior to beginning of the study.
Other illness
- 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.
- Cognitive impairment, with score on Montreal Cognitive Assessment (MoCA) ≤ 20.
Other
- Inability to sit in a chair and perform hand exercises for 20 minutes at the time.
- Social and/or personal circumstances that prevent telemedicine follow-up.
Who the study is looking for
- 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.
Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkin Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.