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Behavioural Intervention
Self-Directed Hand Therapy for Stroke Recovery (SAGEH Trial)
N/A
Recruiting
Led By Steven R Zeiler, M.D, Ph.D.
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Arm and/or hand impairment induced by the stroke
Age 21 years and over
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, post-intervention up to 7 days, 6 months post-stroke
Awards & highlights
SAGEH Trial Summary
This trial will compare outcomes of stroke patients with and without additional self-administered hand therapy to improve dexterity and bimanual skills.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves exercise and occupational therapy rather than medication, side effects may include muscle soreness or fatigue from the activities. There's also a risk of frustration or stress if participants find the self-administered regime challenging.
SAGEH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My arm or hand is impaired due to a stroke.
Select...
I am 21 years old or older.
SAGEH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, post-intervention up to 7 days, 6 months post-stroke
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post-intervention up to 7 days, 6 months post-stroke
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in finger dexterity as assessed by the nine-hole peg test (9PHT)
Secondary outcome measures
Change in Cognitive impairment as assessed by Montreal Cognitive Assessment (MOCA)
Change in arm and hand function using the ARAT
Change in arm hand function using the Fugl Meyer Scale.
+3 moreSAGEH Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Treatment Arm G2Experimental Treatment1 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: Control Group (CG)Active Control1 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.
Group III: Treatment Arm G1Active Control1 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.
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Who is running the clinical trial?
Sheikh Khalifa Stroke InstituteUNKNOWN
Johns Hopkins UniversityLead Sponsor
2,266 Previous Clinical Trials
14,837,437 Total Patients Enrolled
33 Trials studying Stroke
28,862 Patients Enrolled for Stroke
Steven R Zeiler, M.D, Ph.D.Principal InvestigatorJohns Hopkins University
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being admitted to this research effort?
"Affirmative. According to the public information on clinicaltrials.gov, this medical investigation is actively seeking participants as it was recently updated on October 17th 2023. The study launched in September 28th and seeks 60 patients at 1 location."
Answered by AI
Are any new volunteers being accepted for the clinical trial at present?
"Affirmative. According to the details present on clinicaltrials.gov, this medical trial is presently in search of participants and was first posted on September 28th 2023. The entry has since been revised as recently as October 17th 2023 and requires 60 participants from a single centre."
Answered by AI
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