Self-Administered Gaming and Exercise at Home (SAGEH)
Johns Hopkins University
60 participants
Sep 28, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria9
- 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 Criteria7
- 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.
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Interventions
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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05929027