Self-Directed Hand Therapy for Stroke Recovery

(SAGEH Trial)

Overseen By Arnold Gomez, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must not be taking: Botox

Disqualifiers: Severe arm impairment, Severe arthritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 3 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Self-Administered Gaming and Exercise at Home (SAGEH) for stroke recovery?

Research shows that using commercial gaming devices for stroke rehabilitation can improve arm movement and function. A study found that stroke survivors using a virtual-reality gaming system reported improvements in arm use and enjoyed the therapy, suggesting that gaming can be an effective and enjoyable way to aid recovery. ^{1 2 3 4 5}

Is self-directed hand therapy for stroke recovery safe for humans?

Research on self-directed exergaming for stroke recovery shows that it can safely increase exercise duration and repetitions without additional professional supervision. However, concerns about safety and usability for independent home use remain largely unaddressed, indicating a need for further research. ^{1 6 7 8 9}

How does the Self-Administered Gaming and Exercise at Home (SAGEH) treatment differ from other stroke recovery treatments?

The SAGEH treatment is unique because it allows stroke patients to perform hand therapy at home using gaming technology, which is designed to be engaging and motivating. This approach combines exercise with interactive games, making it different from traditional therapies that may not incorporate such technology or the motivational aspect of gaming. ^{1 3 5 7 10}

Research Team

Steven R Zeiler, MD, PhD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

The SAGEH trial is for adults over 21 who've had a stroke within the last 6 weeks, resulting in hand weakness but can still do some exercises. They must be able to communicate in English and give consent. People with severe arm impairment, recent Botox treatments, other major health issues affecting motor function or cognitive impairments are not eligible.

Inclusion Criteria

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

Proficient in speaking and reading English

You meet the JSTTEP criteria and are part of the JSTTEP program.

Exclusion Criteria

My arm is severely impaired and cannot function well.

I have received a Botox injection in my arm after having a stroke.

I cannot sit and do hand exercises for 20 minutes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo baseline gaming, functional, and cognitive assessments while still inpatients

1 week

1 visit (in-person)

Treatment

Participants receive self-administered therapy sessions with telemedicine check-ins over 3 weeks

3 weeks

2 telemedicine check-ins per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Regular follow-up assessments

Treatment Details

Interventions

• Self-Administered Gaming and Exercise at Home (SAGEH)

Trial Overview This study tests if doing extra hand therapy at home after a stroke helps improve manual functions more than just standard care. Participants will either follow their usual outpatient therapy or add self-directed exercises using a device called NoNo to see which method leads to better recovery.

Participant Groups

Group I: Treatment Arm G2 Experimental Treatment 1 Intervention

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.

Group II: Treatment Arm G1 Active Control 1 Intervention

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.

Group III: Control Group (CG) Active Control 1 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 Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Sheikh Khalifa Stroke Institute

Collaborator

Trials

3

Recruited

220+

Findings from Research

An integrative systematic review of 19 studies involving 215 patients found that using commercial gaming devices for stroke rehabilitation can provide enjoyable and tolerable high-intensity practice for upper limb movements, with patients able to engage for up to 180 minutes per week without significant adverse effects.

While there was a noted trend towards improvement in upper limb function, the evidence is still limited and lacks high-quality studies to draw definitive conclusions about the impact on daily living activities or overall effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Commercial gaming devices for stroke upper limb rehabilitation: a systematic review. Thomson, K., Pollock, A., Bugge, C., et al.[2022]

About 18% of therapists currently use gaming, specifically the Nintendo Wii, for stroke upper limb rehabilitation, and 61% would consider using it if the equipment were available.

However, 51% of therapists reported observing adverse events like fatigue and pain, highlighting the need for careful consideration of dosage and potential risks when incorporating gaming into rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Commercial gaming devices for stroke upper limb rehabilitation: a survey of current practice. Thomson, K., Pollock, A., Bugge, C., et al.[2021]

The adapted virtual-reality gaming system for upper-limb rehabilitation was found to be feasible and acceptable for use among 12 community-dwelling stroke survivors, with participants reporting high enjoyment levels and manageable exertion during sessions.

Significant improvements in upper-limb function and increased spontaneous use of the affected arm were observed after nine intervention sessions, indicating preliminary efficacy of the system for stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility, acceptability and preliminary efficacy of a low-cost, virtual-reality based, upper-limb stroke rehabilitation device: a mixed methods study. Warland, A., Paraskevopoulos, I., Tsekleves, E., et al.[2022]

In a study involving 40 participants with chronic stroke, upper-limb rehabilitation using Nintendo Wii gaming showed similar improvements in elbow extension compared to conventional therapy, indicating that gaming can be an effective rehabilitation tool.

Both therapies resulted in small improvements in clinical scores, and neither method significantly increased compensatory trunk movement, suggesting that gaming therapy does not lead to more compensatory strategies than traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving upper-limb and trunk kinematics by interactive gaming in individuals with chronic stroke: A single-blinded RCT. Térémetz, M., Garcia Alvarez, A., Hanneton, S., et al.[2022]

A study involving 24 participants with chronic stroke showed that a self-training program using commercial video games was feasible and led to high adherence, with 72.7% of participants continuing the video game training after the intervention.

Participants reported high levels of enjoyment and satisfaction with both the video game and traditional self-training programs, suggesting that video games may be a more engaging option for ongoing rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of, Adherence to, and Satisfaction With Video Game Versus Traditional Self-Training of the Upper Extremity in People With Chronic Stroke: A Pilot Randomized Controlled Trial. Yacoby, A., Zeilig, G., Weingarden, H., et al.[2019]

In a study involving 30 inpatient stroke survivors, the use of an adapted upper limb exergaming device significantly increased exercise duration to an average of 51 minutes per day, doubling the amount of therapy compared to conventional supervised care.

Participants using the exergaming device performed an average of 104 upper limb repetitions daily, which is eight times more than the 15 repetitions achieved through standard therapy, demonstrating the device's potential to enhance rehabilitation outcomes without additional supervision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-Directed Exergaming for Stroke Upper Limb Impairment Increases Exercise Dose Compared to Standard Care. Broderick, M., Almedom, L., Burdet, E., et al.[2022]

A pilot study involving three adolescents with hemiplegia showed that using adapted gaming technology at home for 30 minutes a day over six to ten months led to significant improvements in finger range of motion.

Participants reported positive experiences with the system, highlighting its ease of use and effectiveness in enhancing their daily living activities, suggesting that gaming technology can be a valuable tool in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of modified remotely monitored in-home gaming technology for improving hand function in adolescents with cerebral palsy. Huber, M., Rabin, B., Docan, C., et al.[2022]

The LSVT BIG program showed promising results in improving upper extremity motor function and self-reported occupational performance in a 52-year-old woman with mild to moderate hemiparesis two years post-stroke.

This study suggests that the LSVT BIG program can be adapted for stroke rehabilitation, and future research will involve a larger, more diverse group to further assess its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lee Silverman Voice Treatment BIG® for a Person With Stroke. Proffitt, RM., Henderson, W., Scholl, S., et al.[2019]

The Home Arm Movement Stroke Training Environment (HAMSTER) program, which uses Kinect games, was found to be usable and engaging for individuals with stroke, highlighting its potential as a motivational home therapy intervention.

A one-month trial of HAMSTER by a participant with chronic stroke showed good compliance and improvements in clinical outcomes, suggesting that this gaming approach could effectively enhance upper extremity function and support recovery at home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability evaluation of a kinematics focused Kinect therapy program for individuals with stroke. Brokaw, EB., Eckel, E., Brewer, BR.[2022]

The MusicGlove is an innovative, low-cost device designed to motivate stroke survivors to practice hand exercises at home by using music to guide movements, which can help improve hand function.

In a single-session study with 10 chronic stroke participants, the MusicGlove demonstrated significant improvements in hand motor performance and increased motivation for training, showing its potential as an effective rehabilitation tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MusicGlove: motivating and quantifying hand movement rehabilitation by using functional grips to play music. Friedman, N., Chan, V., Zondervan, D., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Commercial gaming devices for stroke upper limb rehabilitation: a systematic review. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Commercial gaming devices for stroke upper limb rehabilitation: a survey of current practice. [2021]

3. England pubmed.ncbi.nlm.nih.gov

The feasibility, acceptability and preliminary efficacy of a low-cost, virtual-reality based, upper-limb stroke rehabilitation device: a mixed methods study. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Improving upper-limb and trunk kinematics by interactive gaming in individuals with chronic stroke: A single-blinded RCT. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Feasibility of, Adherence to, and Satisfaction With Video Game Versus Traditional Self-Training of the Upper Extremity in People With Chronic Stroke: A Pilot Randomized Controlled Trial. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Self-Directed Exergaming for Stroke Upper Limb Impairment Increases Exercise Dose Compared to Standard Care. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Feasibility of modified remotely monitored in-home gaming technology for improving hand function in adolescents with cerebral palsy. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Lee Silverman Voice Treatment BIG® for a Person With Stroke. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Usability evaluation of a kinematics focused Kinect therapy program for individuals with stroke. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

MusicGlove: motivating and quantifying hand movement rehabilitation by using functional grips to play music. [2020]