Self-Administered Gaming and Exercise at Home (SAGEH)

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:

• Age 21 years and over

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

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

• Meet JSTTEP criteria and are enrolled in JSTTEP.

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

• Proficient in speaking and reading English.

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

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

• Ability to give informed consent.

Locations
United States
Maryland
Johns Hopkin
RECRUITING
Baltimore
Contact Information
Primary
Steven R. Zeiler, M.D., Ph.D.
sz@jhmi.edu
3035207404
Backup
Arnold Gomez, Ph.D.
adgomez@jhu.edu
Time Frame
Start Date: 2023-09-28
Estimated Completion Date: 2027-12
Participants
Target number of participants: 60
Treatments
Active_comparator: Treatment Arm G1
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.
Experimental: Treatment Arm G2
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.
No_intervention: Control Group (CG)
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.
Related Therapeutic Areas
Sponsors
Collaborators: Sheikh Khalifa Stroke Institute
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov