StrokeSAGEHNCT05929027
Self-Administered Gaming and Exercise at Home (SAGEH)
A study testing NoNo and occupational therapy - self directed in people with Stroke and Hand Weakness, run by Johns Hopkins University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke, Hand Weakness
- What is being tested?
- NoNo and occupational therapy - self directed
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2023to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Arnold Gomez, Ph.D. contact
United States1 site, 1 recruiting
- Recruiting
Johns Hopkin
Baltimore, Maryland, 21287-6953
Steven R Zeiler, MD, PhD, 303-520-7404, sz@jhmi.edu
About this study
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.
Read the detailed description
The primary goal of this study is to determine if adding self-administered, daily hand therapy to standard of care improves post-stroke clinical outcomes. The investigators will investigate two distinct approaches to implement self-administered therapy and observe how the participants fare to the standard outpatient visits-a total of 3 experimental groups. The first approach consists of daily exercise routines; the second approach consists of using a novel, portable, electronic device that was intentionally designed to address the difficult problem of hand rehabilitation. Specifically, the device combines hand therapy with video game-like tasks. Both post-stroke approaches will be partially supervised by an occupational therapist via short telemedicine sessions, in the context of standard-of-care telemedicine clinic (JSTTEP - described below) to promote safety and proper form during the exercises or device utilization.
The primary outcome is a standardized, post-intervention functional hand metric. This pilot study will include both measurement of improvements with respect to a baseline, and comparison between groups, using the therapist-provided therapy sessions as control and gold standard.
The investigators will recruit 60 adult stroke survivors. The total will be divided into three matched groups. Two of the groups (G1 and G2, 20 participants each) will receive therapy-based interventions in addition to the standard of care, and the remaining control group (CG, 20 participants) will receive the standard of care and no additional therapy.
Current standard of care regarding stroke inpatients requires admission to Johns Hopkins Comprehensive Stroke Center. At discharge, depending upon the stroke severity, patients can either be discharged to a facility or to home. This study is specifically targeting patients discharged to home.
Importantly, patients going home are followed in the Joint Stroke Transitional Technology-Enhanced Program (JSTTEP). JSTTEP is the standard of care, inter-disciplinary, telemedicine program that operates during the first month after stroke to facilitate the patient's transition from hospital to home. Each shared visit includes a physician and therapist evaluation and combined treatment plan. A single multidisciplinary online group education session is completed within 1 month after stoke hospitalization and is open to patients and care partners.
Stroke patients who are being discharged home from the Johns Hopkins Comprehensive Stroke Center via JSTTEP are eligible for participation in this study. A consecutive series of patients who meet inclusion criteria will be approached for consent to participate in this study. Inclusion (or exclusion) will be determined using the criteria described in the Inclusion/Exclusion Criteria Section, using a HIPAA Privacy Authorization Form. Upon consenting to participate in the study, each participant will undergo a Baseline Assessment visit, while still an inpatient, composed of a gaming, functional, and cognitive assessments (described below under Baseline Assessment). These assessments also work as screenings; that is, if, after signing the consent and during the enrollment process, a patient fails to meet enrollment criteria, the investigators can halt enrollment. Similarly, if a patient does meet the enrollment criteria, the participants will be assigned into a treatment group (as described below in the Randomization Section), and will receive instructions according to the participants group
- Conditions
- Stroke, Hand Weakness
- Being tested
- NoNo, occupational therapy - self directed
- Keywords
- stroke, stroke recovery, hand weakness, video game
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NoNoBehavioural
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.
occupational therapy - self directedBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm G1 | Active comparator | The interventions will consist of 5 daily sessions over 3 weeks. Because the interventions are self-administered, the sessions are unsupervised in the sense that the sessions do not include synchronous therapy provided by a clinician or a therapist. Instead, during each week, the intervention will include 2 short (less than 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. Receives: Behavioral: occupational therapy - self directed |
| Treatment Arm G2 | Experimental | The intervention will consist of 5 daily sessions over 3 weeks. Because the interventions are self-administered, the sessions are unsupervised in the sense that the sessions do not include synchronous therapy provided by a clinician or a therapist. Instead, during each week, the intervention will include 2 short (less than 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. In this treatment arm, participants will use a knob-like computer interface connected to a tablet. The tablet features a series of game-like tasks to be carried out by moving the interface with the fingers. The target intervention is scheduled for 1.5 hours per day, which is typically divided into two sessions of 40 minutes with a 10-minute break in between. Receives: Behavioral: NoNo |
| Control Group (CG) | No intervention | Unlike G1 and G2, the CG will remain in the standard of care treatment plan but will not receive any additional therapy. That is to say, participants will follow standard therapy plans as dictated by normal post-stroke hospital discharge planning. The only difference from the standard of care will be that participants in CG will still receive identical check-in appointments with follow-up questions concerning recovery and activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in finger dexterity as assessed by the nine-hole peg test (9PHT)
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.
Measured: Baseline, post-intervention up to 7 days, 6 months post-stroke
Secondary outcomes (6)
Change in arm hand function using the Fugl Meyer Scale.
Change in arm and hand function at the impairment level as assessed by the Fugl Meyer Upper Extremity Assessment of motor control (FM-UE). The FM-UE uses a 3-point ordinal scale to evaluate sensorimotor function of the arm and hand of the affected upper extremity during reach and grasp movements in and out of synergistic movement patterns
Measured: Baseline, up to 7 days post-intervention, and 6 months post-stroke
Change in arm and hand function using the ARAT
Change in arm and hand function at the activity level as assessed by the Action Research Arm Test (ARAT). The ARAT is a 19-item measure with 4 subtests (grip, grasp, pinch, and gross arm movement) and 57 possible points. Each subtest has tasks varying in complexity that are graded using a 4-point ordinal scale to describe if tasks are completed with normal movement, movement that requires increased time, are partially completed, or unable to be completed.
Measured: Baseline, up to 7 days post-intervention, and 6 months post-stroke
Change in fingertip individuation index as assessed by the Cyber Glove
Change in fingertip individuation index as assessed by kinematic measurement of digit movement using the CyberGlove. The Cyberglove is a wearable device that uses sensor-based technology to capture joint range of motion. Full extension and flexion of each digit in isolation will be captured using this technology.
Measured: Baseline, up to 7 days post-intervention, and 6 months post-stroke
Change in Cognitive impairment as assessed by Montreal Cognitive Assessment (MOCA)
Montreal Cognitive Assessment (MOCA) will be used. The MOCA is a screening assessment for mild cognitive impairment. It has 30 questions that assess different domains of cognition including: executive functions, memory, language, attention, and abstract reasoning.
Measured: Baseline, up to 7 days post-intervention, and 6 months post-stroke
Engagement and enjoyment of the different sub-aspects within each additional therapy approach as assessed by satisfaction surveys developed by the study team
Engagement and enjoyment of the different sub-aspects within each additional therapy approach as assessed by satisfaction surveys which will contain a combination of questions including Likert scale-based questions, ordinal questions, and fill-in-the-blank questions (the study team will create this survey specific for this study.
Measured: up to 7 days post--intervention
Change in disability as assessed by the modified Rankin score
Change in disability as assessed by the modified Rankin Scale (mRS). The mRS is a widely used clinician reported , single-item measure of global disability
Measured: Baseline, up to 7 days pot-intervention, and 6 months post-stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start28 Sep 2023
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Sheikh Khalifa Stroke Institute
- Responsible party
- Sponsor
- Investigators
- Steven R Zeiler, M.D, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929027
- Sponsor's protocol ID
- IRB00340964
- Acronym
- SAGEH
- Status last verified
- Aug 2026
- First submitted
- 23 Jun 2023
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Johansson GM, Hager CK. A modified standardized nine hole peg test for valid and reliable kinematic assessment of dexterity post-stroke. J Neuroeng Rehabil. 2019 Jan 14;16(1):8. doi: 10.1186/s12984-019-0479-y.
PubMed 30642350Bejot Y, Daubail B, Giroud M. Epidemiology of stroke and transient ischemic attacks: Current knowledge and perspectives. Rev Neurol (Paris). 2016 Jan;172(1):59-68. doi: 10.1016/j.neurol.2015.07.013. Epub 2015 Dec 21.
PubMed 26718592Heron M. Deaths: Leading Causes for 2019. Natl Vital Stat Rep. 2021 Jul;70(9):1-114.
PubMed 34520342Brunnstrom S. Motor testing procedures in hemiplegia: based on sequential recovery stages. Phys Ther. 1966 Apr;46(4):357-75. doi: 10.1093/ptj/46.4.357. No abstract available.
PubMed 5907254Nakayama H, Jorgensen HS, Raaschou HO, Olsen TS. Recovery of upper extremity function in stroke patients: the Copenhagen Stroke Study. Arch Phys Med Rehabil. 1994 Apr;75(4):394-8. doi: 10.1016/0003-9993(94)90161-9.
PubMed 8172497Kotila M, Waltimo O, Niemi ML, Laaksonen R, Lempinen M. The profile of recovery from stroke and factors influencing outcome. Stroke. 1984 Nov-Dec;15(6):1039-44. doi: 10.1161/01.str.15.6.1039.
PubMed 6506115Colebatch JG, Gandevia SC. The distribution of muscular weakness in upper motor neuron lesions affecting the arm. Brain. 1989 Jun;112 ( Pt 3):749-63. doi: 10.1093/brain/112.3.749.
PubMed 2731028Jebsen RH, Taylor N, Trieschmann RB, Trotter MJ, Howard LA. An objective and standardized test of hand function. Arch Phys Med Rehabil. 1969 Jun;50(6):311-9. No abstract available.
PubMed 5788487Barry AJ, Triandafilou KM, Stoykov ME, Bansal N, Roth EJ, Kamper DG. Survivors of Chronic Stroke Experience Continued Impairment of Dexterity But Not Strength in the Nonparetic Upper Limb. Arch Phys Med Rehabil. 2020 Jul;101(7):1170-1175. doi: 10.1016/j.apmr.2020.01.018. Epub 2020 Feb 28.
PubMed 32113974Krakauer JW, Kitago T, Goldsmith J, Ahmad O, Roy P, Stein J, Bishop L, Casey K, Valladares B, Harran MD, Cortes JC, Forrence A, Xu J, DeLuzio S, Held JP, Schwarz A, Steiner L, Widmer M, Jordan K, Ludwig D, Moore M, Barbera M, Vora I, Stockley R, Celnik P, Zeiler S, Branscheidt M, Kwakkel G, Luft AR. Comparing a Novel Neuroanimation Experience to Conventional Therapy for High-Dose Intensive Upper-Limb Training in Subacute Stroke: The SMARTS2 Randomized Trial. Neurorehabil Neural Repair. 2021 May;35(5):393-405. doi: 10.1177/15459683211000730. Epub 2021 Mar 20.
PubMed 33745372Murphy TH, Corbett D. Plasticity during stroke recovery: from synapse to behaviour. Nat Rev Neurosci. 2009 Dec;10(12):861-72. doi: 10.1038/nrn2735. Epub 2009 Nov 4.
PubMed 19888284Winstein CJ, Stein J, Arena R, Bates B, Cherney LR, Cramer SC, Deruyter F, Eng JJ, Fisher B, Harvey RL, Lang CE, MacKay-Lyons M, Ottenbacher KJ, Pugh S, Reeves MJ, Richards LG, Stiers W, Zorowitz RD; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Quality of Care and Outcomes Research. Guidelines for Adult Stroke Rehabilitation and Recovery: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2016 Jun;47(6):e98-e169. doi: 10.1161/STR.0000000000000098. Epub 2016 May 4.
PubMed 27145936BENNETT EL, DIAMOND MC, KRECH D, ROSENZWEIG MR. CHEMICAL AND ANATOMICAL PLASTICITY BRAIN. Science. 1964 Oct 30;146(3644):610-9. doi: 10.1126/science.146.3644.610. No abstract available.
PubMed 14191699McDonald MW, Hayward KS, Rosbergen ICM, Jeffers MS, Corbett D. Is Environmental Enrichment Ready for Clinical Application in Human Post-stroke Rehabilitation? Front Behav Neurosci. 2018 Jul 11;12:135. doi: 10.3389/fnbeh.2018.00135. eCollection 2018.
PubMed 30050416Vive S, Af Geijerstam JL, Kuhn HG, Bunketorp-Kall L. Enriched, Task-Specific Therapy in the Chronic Phase After Stroke: An Exploratory Study. J Neurol Phys Ther. 2020 Apr;44(2):145-155. doi: 10.1097/NPT.0000000000000309.
PubMed 32118616
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Administered Gaming and Exercise at Home (SAGEH)
- ClinicalTrials.gov ID
- NCT05929027
- Acronym / sponsor ID
- SAGEH / IRB00340964
- Conditions
- Stroke, Hand Weakness
- Keywords
- stroke, stroke recovery, hand weakness, video game
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Sheikh Khalifa Stroke Institute
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary goal of this study is to determine if adding self-administered, daily hand therapy to standard of care improves post-stroke clinical outcomes. The investigators will investigate two distinct approaches to implement self-administered therapy and observe how the participants fare to the standard outpatient visits-a total of 3 experimental groups. The first approach consists of daily exercise routines; the second approach consists of using a novel, portable, electronic device that was intentionally designed to address the difficult problem of hand rehabilitation. Specifically, the device combines hand therapy with video game-like tasks. Both post-stroke approaches will be partially supervised by an occupational therapist via short telemedicine sessions, in the context of standard-of-care telemedicine clinic (JSTTEP - described below) to promote safety and proper form during the exercises or device utilization.
The primary outcome is a standardized, post-intervention functional hand metric. This pilot study will include both measurement of improvements with respect to a baseline, and comparison between groups, using the therapist-provided therapy sessions as control and gold standard.
The investigators will recruit 60 adult stroke survivors. The total will be divided into three matched groups. Two of the groups (G1 and G2, 20 participants each) will receive therapy-based interventions in addition to the standard of care, and the remaining control group (CG, 20 participants) will receive the standard of care and no additional therapy.
Current standard of care regarding stroke inpatients requires admission to Johns Hopkins Comprehensive Stroke Center. At discharge, depending upon the stroke severity, patients can either be discharged to a facility or to home. This study is specifically targeting patients discharged to home.
Importantly, patients going home are followed in the Joint Stroke Transitional Technology-Enhanced Program (JSTTEP). JSTTEP is the standard of care, inter-disciplinary, telemedicine program that operates during the first month after stroke to facilitate the patient's transition from hospital to home. Each shared visit includes a physician and therapist evaluation and combined treatment plan. A single multidisciplinary online group education session is completed within 1 month after stoke hospitalization and is open to patients and care partners.
Stroke patients who are being discharged home from the Johns Hopkins Comprehensive Stroke Center via JSTTEP are eligible for participation in this study. A consecutive series of patients who meet inclusion criteria will be approached for consent to participate in this study. Inclusion (or exclusion) will be determined using the criteria described in the Inclusion/Exclusion Criteria Section, using a HIPAA Privacy Authorization Form. Upon consenting to participate in the study, each participant will undergo a Baseline Assessment visit, while still an inpatient, composed of a gaming, functional, and cognitive assessments (described below under Baseline Assessment). These assessments also work as screenings; that is, if, after signing the consent and during the enrollment process, a patient fails to meet enrollment criteria, the investigators can halt enrollment. Similarly, if a patient does meet the enrollment criteria, the participants will be assigned into a treatment group (as described below in the Randomization Section), and will receive instructions according to the participants group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm G1 | Active comparator | Behavioral: occupational therapy - self directedThe interventions will consist of 5 daily sessions over 3 weeks. Because the interventions are self-administered, the sessions are unsupervised in the sense that the sessions do not include synchronous therapy provided by a clinician or a therapist. Instead, during each week, the intervention will include 2 short (less than 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. |
| Treatment Arm G2 | Experimental | Behavioral: NoNoThe intervention will consist of 5 daily sessions over 3 weeks. Because the interventions are self-administered, the sessions are unsupervised in the sense that the sessions do not include synchronous therapy provided by a clinician or a therapist. Instead, during each week, the intervention will include 2 short (less than 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. In this treatment arm, participants will use a knob-like computer interface connected to a tablet. The tablet features a series of game-like tasks to be carried out by moving the interface with the fingers. The target intervention is scheduled for 1.5 hours per day, which is typically divided into two sessions of 40 minutes with a 10-minute break in between. |
| Control Group (CG) | No intervention | –Unlike G1 and G2, the CG will remain in the standard of care treatment plan but will not receive any additional therapy. That is to say, participants will follow standard therapy plans as dictated by normal post-stroke hospital discharge planning. The only difference from the standard of care will be that participants in CG will still receive identical check-in appointments with follow-up questions concerning recovery and activities. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NoNoParticipants 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. | Behavioural | Treatment Arm G2 |
| occupational therapy - self directedParticipants 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. | Behavioural | Treatment Arm G1 |
Primary outcome
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.
6 secondary outcomes
Change in arm hand function using the Fugl Meyer Scale.
Time frame: Baseline, up to 7 days post-intervention, and 6 months post-stroke
Change in arm and hand function using the ARAT
Time frame: Baseline, up to 7 days post-intervention, and 6 months post-stroke
Change in fingertip individuation index as assessed by the Cyber Glove
Time frame: Baseline, up to 7 days post-intervention, and 6 months post-stroke
Change in Cognitive impairment as assessed by Montreal Cognitive Assessment (MOCA)
Time frame: Baseline, up to 7 days post-intervention, and 6 months post-stroke
Engagement and enjoyment of the different sub-aspects within each additional therapy approach as assessed by satisfaction surveys developed by the study team
Time frame: up to 7 days post--intervention
Change in disability as assessed by the modified Rankin score
Time frame: Baseline, up to 7 days pot-intervention, and 6 months post-stroke
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Background: PubMed 30642350Johansson GM, Hager CK. A modified standardized nine hole peg test for valid and reliable kinematic assessment of dexterity post-stroke. J Neuroeng Rehabil. 2019 Jan 14;16(1):8. doi: 10.1186/s12984-019-0479-y.
- Background: PubMed 26718592Bejot Y, Daubail B, Giroud M. Epidemiology of stroke and transient ischemic attacks: Current knowledge and perspectives. Rev Neurol (Paris). 2016 Jan;172(1):59-68. doi: 10.1016/j.neurol.2015.07.013. Epub 2015 Dec 21.
- Background: PubMed 34520342Heron M. Deaths: Leading Causes for 2019. Natl Vital Stat Rep. 2021 Jul;70(9):1-114.
- Background: PubMed 5907254Brunnstrom S. Motor testing procedures in hemiplegia: based on sequential recovery stages. Phys Ther. 1966 Apr;46(4):357-75. doi: 10.1093/ptj/46.4.357. No abstract available.
- Background: PubMed 8172497Nakayama H, Jorgensen HS, Raaschou HO, Olsen TS. Recovery of upper extremity function in stroke patients: the Copenhagen Stroke Study. Arch Phys Med Rehabil. 1994 Apr;75(4):394-8. doi: 10.1016/0003-9993(94)90161-9.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arnold Gomez, Ph.D. contact
Steven R Zeiler, M.D, Ph.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NoNo and occupational therapy - self directed in people with Stroke and Hand Weakness, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Steven R. Zeiler, M.D., Ph.D. (3035207404, sz@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05929027, which also lists 35 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.