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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effects of self-administered hand therapy for individuals recovering from a stroke. It aims to determine if regular exercises and games at home, known as Self-Administered Gaming and Exercise at Home (SAGEH), can improve hand and arm function more effectively than usual care alone. Participants will either engage in these self-guided sessions with occasional telemedicine check-ins or follow the standard care routine. Ideal candidates are those who have recently experienced a stroke, have impaired hand or arm function, and are comfortable with remote check-ins. As an unphased trial, this study provides a unique opportunity to contribute to innovative stroke recovery research.

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 prior data suggests that self-administered hand therapy is safe for stroke recovery?

Research has shown that self-guided gaming and exercise can be safe for people recovering from a stroke. In one study, participants who used gaming technology for arm recovery after a stroke exercised more, doubling their exercise time and performing eight times more repetitions compared to traditional methods. This suggests that the treatment is generally well-tolerated.

Additionally, studies have examined the use of digital technology at home, such as telerehabilitation and gamification (adding game-like features), in stroke recovery. These methods help individuals safely and effectively improve arm movement at home.

While specific details on side effects aren't provided, these findings suggest that self-directed gaming and exercise treatments are safe and can be effectively included in stroke recovery plans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for stroke recovery because they offer a self-directed approach that can be done at home, making rehabilitation more accessible. Unlike traditional therapies that often require in-person sessions with a therapist, these treatments involve self-administered exercises and gaming through a tablet interface, allowing participants to engage in rehabilitation on their own schedule. The use of a knob-like computer interface for game-like tasks is a novel delivery method, encouraging active participation and potentially improving motivation and adherence. This self-directed method is complemented by brief telemedicine check-ins with a licensed occupational therapist, ensuring safety and guidance without the need for constant supervision.

What evidence suggests that this trial's treatments could be effective for stroke recovery?

This trial will evaluate the effectiveness of self-directed gaming and exercise at home through the Self-Administered Gaming and Exercise at Home (SAGEH) program for stroke recovery. Participants in Treatment Arm G1 will engage in self-administered sessions focusing on stretches, warm-up, and strengthening exercises to improve hand function. Meanwhile, participants in Treatment Arm G2 will use a knob-like computer interface connected to a tablet for game-like tasks to enhance hand dexterity and coordination. Studies have shown that such self-directed activities can double exercise time and increase repetitions by eight times for stroke patients, improving hand function through frequent and consistent practice. One study found that using interactive gaming technology for self-directed rehabilitation improved arm use in stroke survivors. These findings suggest that adding self-administered hand therapy to standard care could enhance recovery. ^{2 3 6 7 8}

Who Is on the Research Team?

Steven R Zeiler, MD, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8593287/

Self-Directed Exergaming for Stroke Upper Limb ... Self-directed adapted exergaming enabled participants in our stroke inpatient cohort to increase exercise duration 2-fold, and repetitions 8-fold, compared to ...

2. withpower.com withpower.com/trial/phase-stroke-5-2023-a2eed

Self-Directed Hand Therapy for Stroke Recovery (SAGEH Trial) This study aims at comparing manual function outcomes between the standard of care and additional self-administered hand therapy after stroke.

3. hra.nhs.uk hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/self-directed-adapted-gaming-exercises-for-stroke-survivors-sage/

Self-directed Adapted Gaming Exercises for stroke survivors This study was a pilot RCT, testing the use of an interactive gaming technology (GripAble) for self-directed arm rehabilitation after stroke.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6252641/

Rehabilitation via HOMe Based gaming exercise for the ... This study aims to determine the safety, feasibility and acceptability of the Neurofenix platform for home-based rehabilitation of the upper-limb poststroke. A ...

5. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/15459683211041313

Self-Directed Exergaming for Stroke Upper Limb ... Here we quantify the exercise dose achieved by inpatient stroke survivors using an adapted upper limb (UL) exercise gaming (exergaming) device ...

6. clinconnect.io clinconnect.io/trials/NCT05929027

Self-Administered Gaming and Exercise at Home (SAGEH) This study aims at comparing manual function outcomes between the standard of care and additional self-administered hand therapy after stroke.

7. journals.sagepub.com journals.sagepub.com/doi/full/10.1177/02692155231189257

The use of home-based digital technology to support post- ... The digital technologies used in post-stroke upper limb rehabilitation were multimodal, and system-based comprising telerehabilitation, gamification, virtual ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10744717/

Home-Based Virtual Reality Exergame Program after Stroke ... This study will aim to determine the effectiveness of home-based VRET for patients with stroke who have been discharged from the hospital.