Self-administered gaming and exercise program for stroke recovery
Self-Administered Gaming and Exercise at Home (SAGEH)
This study tests whether adding a fun gaming and exercise program to regular therapy can help stroke survivors improve their hand strength and function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05929027 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of standard care with additional self-administered hand therapy for stroke survivors experiencing hand weakness. Participants will be divided into three groups: two will receive daily exercise routines or use a novel electronic device that combines hand therapy with video game-like tasks, while the control group will receive standard outpatient therapy. The study aims to assess improvements in hand function through standardized metrics after the intervention period. Occupational therapists will supervise the therapy sessions via telemedicine to ensure safety and proper technique.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and over who have experienced a stroke within the last 6 weeks and have arm or hand impairments.
Not a fit: Patients with severe arm impairment or those with a history of conditions that interfere with motor function may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance hand recovery and functional outcomes for stroke survivors.
How similar studies have performed: Previous studies have shown promise in using technology and high-frequency therapy for stroke recovery, suggesting this approach could be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Baltimore, Maryland
- Johns Hopkin — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Steven R Zeiler, M.D, Ph.D. — Johns Hopkins University
- Study coordinator: Steven R. Zeiler, M.D., Ph.D.
- Email: sz@jhmi.edu
- Phone: 3035207404
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.