Self-Administered Gaming and Exercise at Home (SAGEH)

NCT05929027 | Recruiting

• 1 other identifier: IRB00340964
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Hand Weakness

Keywords

stroke; stroke recovery; hand weakness; video game

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, post-intervention up to 7 days, 6 months post-stroke

Secondary Outcomes (6)

• Change in arm hand function using the Fugl Meyer Scale.

  Baseline, up to 7 days post-intervention, and 6 months post-stroke

• Change in arm and hand function using the ARAT

  Baseline, up to 7 days post-intervention, and 6 months post-stroke

• Change in fingertip individuation index as assessed by the Cyber Glove

  Baseline, up to 7 days post-intervention, and 6 months post-stroke

• Change in Cognitive impairment as assessed by Montreal Cognitive Assessment (MOCA)

  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

  up to 7 days post--intervention

Study Arms (3)

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.

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.

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.

Interventions

NoNo BEHAVIORAL

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.

Treatment Arm G2

occupational therapy - self directed BEHAVIORAL

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.

Treatment Arm G1

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Sheikh Khalifa Stroke Institute: collaborator

Study Sites (1)

Johns Hopkin

Baltimore, Maryland, 21287-6953, United States

RECRUITING

Related Publications (35)

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MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Steven R Zeiler, M.D, Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven R. Zeiler, M.D., Ph.D.

CONTACT

3035207404; sz@jhmi.edu

Arnold Gomez, Ph.D.

CONTACT

adgomez@jhu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: July 3, 2023
• Study Start: September 28, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)