Actively Recruiting

Phase Not Applicable
Age: 21Years +
All Genders
NCT05929027

Self-Administered Gaming and Exercise at Home (SAGEH)

Led by Johns Hopkins University · Updated on 2025-07-18

60

Participants Needed

1

Research Sites

217 weeks

Total Duration

On this page

Sponsors

J

Johns Hopkins University

Lead Sponsor

S

Sheikh Khalifa Stroke Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Self-Administered Gaming and Exercise at Home (SAGEH)

Who Can Participate

Age: 21Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 21 years and over
  • Stroke confirmed by CT or MRI within the previous 6 weeks
  • Arm and/or hand impairment caused by the stroke
  • Meet JSTTEP criteria and are enrolled in JSTTEP
  • Admitted to Johns Hopkins Hospital inpatient stroke service
  • Proficient in speaking and reading English
  • Willing and able to be contacted remotely for telemedicine
  • No history of prior ischemic or hemorrhagic stroke with motor deficits (prior stroke without upper limb motor symptoms allowed)
  • Ability to give informed consent
Not Eligible

You will not qualify if you...

  • Arm impairment too severe (Fugl-Meyer Upper Extremity score under 40) at baseline testing
  • Recent Botox injection to upper limb since stroke onset
  • Physical or neurological conditions interfering with study or motor function tests (e.g., severe arthritis, neuropathy, Parkinson's disease)
  • Terminal illness with life expectancy less than 6 months
  • Unable to sit in a chair and perform hand exercises for 20 minutes at a time
  • Cognitive impairment with Montreal Cognitive Assessment score 20 or below
  • Social or personal circumstances preventing telemedicine follow-up

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Johns Hopkin

Baltimore, Maryland, United States, 21287-6953

Actively Recruiting

Loading map...

Research Team

S

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

CONTACT

A

Arnold Gomez, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here