NCT05929027 · Johns Hopkins University
Self-Administered Gaming and Exercise at Home (SAGEH)
(SAGEH)
What this study is about
This study aims at comparing manual function outcomes between the the usual treatment 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.
View original scientific 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.
Interventions
BEHAVIORAL
NoNo
Participants in the G2 group will use the Twirlstone (knob-like) device to play a videogame called Nono's World. The Twirlstone is an electromechanical device that resembles a knob and a standard joystick (identical to the discontinued Atari CX-20 Controller). The knob can rotate or move in a push-pull fashion. To control the game's character (an axolotl called Nono), a signal about the knob motion is relayed to the computer wirelessly. This device has been certified by Johns Hopkins University's Clinical Engineering Services, where it was deemed less than minimum risk. The game has been custom built to allow participants to take control of the character using subtle manipulative finger movements to accomplish game-like tasks. The investigators will use portable communication devices to carry out telemedicine sessions. All devices and are low-power battery-operated tools for encouraging hand movement and the components are approved for use in the commercial market.
BEHAVIORAL
occupational therapy - self directed
Participants 5 daily sessions over 3 weeks consisting of self-administered, unsupervised occupational therpay. Additionally, participants will have 2, \<15 minutes telemedicine check-in appointments (not standard of care) provided by a licensed occupational therapist for the purposes of assessing safety and providing guidance for the unsupervised sessions. The intervention will focus on stretches, warm-up and strengthening exercises aimed at improving hand function. The investigators will use portable communication devices for the purposes of carrying out telemedicine sessions. All devices and are low-power battery-operated tools for encouraging hand movement and the components are approved for use in the commercial market.
Primary outcome measures
Change in finger dexterity as assessed by the nine-hole peg test (9PHT)
Time frame: Baseline, post-intervention up to 7 days, 6 months post-stroke
The Nine-Hole Peg Test (9HPT) is used to measure finger dexterity in patients with various neurological diagnoses. Participants are asked to place pegs into the holes one at a time, then remove them one at a time, and place them back in the container as fast as they can.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
- Baltimore, Maryland
Collaborators
Sheikh Khalifa Stroke Institute
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 18, 2025 · Source of record for eligibility and locations