Self-Administered Gaming and Exercise at Home (SAGEH)

Stroke Clinical Trial

— SAGEH  

Official title:

Self-Administered Gaming and Exercise at Home (SAGEH)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05929027
• Other study ID #: IRB00340964
• Status: Recruiting
• Phase: N/A
• Start date: September 28, 2023
• Est. completion date: December 2025

Study information

• Verified date: October 2023
• Source: Johns Hopkins University
• Contact: Steven R. Zeiler, M.D., Ph.D.
• Phone: 3035207404
• Email: sz[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Age 21 years and over

2. Stroke confirmed by CT or MRI within the previous 6 weeks.

3. Arm and/or hand impairment induced by the stroke.

4. Meet JSTTEP criteria and are enrolled in JSTTEP.

5. Admitted to the Johns Hopkins Hospital (JHH) inpatient stroke service.

6. Proficient in speaking and reading English.

7. Willing and capable to contacted remotely for all necessary telemedicine contacts.

8. No history of prior ischemic or hemorrhagic stroke with associated motor deficits (prior stroke with no upper limb motor symptoms is allowed)

9. Ability to give informed consent.

Exclusion Criteria:

1. Arm impairment that is too severe (FM-UE < 40) on day of baseline testing prior to beginning of the study.

2. Recent Botox injection to upper limb (since stroke onset).

3. 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).

4. Terminal illness with life expectancy < 6 months.

5. Inability to sit in a chair and perform hand exercises for 20 minutes at the time.

6. Cognitive impairment, with score on Montreal Cognitive Assessment (MoCA) = 20.

7. Social and/or personal circumstances that prevent telemedicine follow-up.

Related Conditions & MeSH terms

• Asthenia
• Hand Weakness
• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkin	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Sheikh Khalifa Stroke Institute

Country where clinical trial is conducted

United States, 

References & Publications (35)

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* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Baseline, up to 7 days post-intervention, and 6 months post-stroke
Secondary	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.	Baseline, up to 7 days post-intervention, and 6 months post-stroke
Secondary	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.	Baseline, up to 7 days post-intervention, and 6 months post-stroke
Secondary	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.	Baseline, up to 7 days post-intervention, and 6 months post-stroke
Secondary	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.	up to 7 days post--intervention
Secondary	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	Baseline, up to 7 days pot-intervention, and 6 months post-stroke