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Self-Administered Gaming and Exercise at Home (SAGEH) (SAGEH)

Primary Purpose

Stroke, Hand Weakness

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NoNo
occupational therapy - self directed
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, stroke recovery, hand weakness, video game

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: Arm impairment that is too severe (FM-UE < 40) on day of baseline testing prior to beginning of the study. Recent Botox injection to upper limb (since stroke onset). 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). Terminal illness with life expectancy < 6 months. Inability to sit in a chair and perform hand exercises for 20 minutes at the time. Cognitive impairment, with score on Montreal Cognitive Assessment (MoCA) ≤ 20. Social and/or personal circumstances that prevent telemedicine follow-up.

Sites / Locations

  • Johns HopkinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

No Intervention

Arm Label

Treatment Arm G1

Treatment Arm G2

Control Group (CG)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in finger dexterity as assessed by the nine-hole peg test (9PHT)
The Nine-Hole Peg Test (9HPT) is used to measure finger dexterity in patients with various neurological diagnoses. Participants are asked to place pegs into the holes one at a time, then remove them one at a time, and place them back in the container as fast as they can.

Secondary Outcome Measures

Change in arm hand function using the Fugl Meyer Scale.
Change in arm and hand function at the impairment level as assessed by the Fugl Meyer Upper Extremity Assessment of motor control (FM-UE). The FM-UE uses a 3-point ordinal scale to evaluate sensorimotor function of the arm and hand of the affected upper extremity during reach and grasp movements in and out of synergistic movement patterns
Change in arm and hand function using the ARAT
Change in arm and hand function at the activity level as assessed by the Action Research Arm Test (ARAT). The ARAT is a 19-item measure with 4 subtests (grip, grasp, pinch, and gross arm movement) and 57 possible points. Each subtest has tasks varying in complexity that are graded using a 4-point ordinal scale to describe if tasks are completed with normal movement, movement that requires increased time, are partially completed, or unable to be completed.
Change in fingertip individuation index as assessed by the Cyber Glove
Change in fingertip individuation index as assessed by kinematic measurement of digit movement using the CyberGlove. The Cyberglove is a wearable device that uses sensor-based technology to capture joint range of motion. Full extension and flexion of each digit in isolation will be captured using this technology.
Change in Cognitive impairment as assessed by Montreal Cognitive Assessment (MOCA)
Montreal Cognitive Assessment (MOCA) will be used. The MOCA is a screening assessment for mild cognitive impairment. It has 30 questions that assess different domains of cognition including: executive functions, memory, language, attention, and abstract reasoning.
Engagement and enjoyment of the different sub-aspects within each additional therapy approach as assessed by satisfaction surveys developed by the study team
Engagement and enjoyment of the different sub-aspects within each additional therapy approach as assessed by satisfaction surveys which will contain a combination of questions including Likert scale-based questions, ordinal questions, and fill-in-the-blank questions (the study team will create this survey specific for this study.
Change in disability as assessed by the modified Rankin score
Change in disability as assessed by the modified Rankin Scale (mRS). The mRS is a widely used clinician reported , single-item measure of global disability

Full Information

First Posted
June 23, 2023
Last Updated
October 17, 2023
Sponsor
Johns Hopkins University
Collaborators
Sheikh Khalifa Stroke Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05929027
Brief Title
Self-Administered Gaming and Exercise at Home (SAGEH)
Acronym
SAGEH
Official Title
Self-Administered Gaming and Exercise at Home (SAGEH)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2023 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Sheikh Khalifa Stroke Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
The primary goal of this study is to determine if adding self-administered, daily hand therapy to standard of care improves post-stroke clinical outcomes. The investigators will investigate two distinct approaches to implement self-administered therapy and observe how the participants fare to the standard outpatient visits-a total of 3 experimental groups. The first approach consists of daily exercise routines; the second approach consists of using a novel, portable, electronic device that was intentionally designed to address the difficult problem of hand rehabilitation. Specifically, the device combines hand therapy with video game-like tasks. Both post-stroke approaches will be partially supervised by an occupational therapist via short telemedicine sessions, in the context of standard-of-care telemedicine clinic (JSTTEP - described below) to promote safety and proper form during the exercises or device utilization. The primary outcome is a standardized, post-intervention functional hand metric. This pilot study will include both measurement of improvements with respect to a baseline, and comparison between groups, using the therapist-provided therapy sessions as control and gold standard. The investigators will recruit 60 adult stroke survivors. The total will be divided into three matched groups. Two of the groups (G1 and G2, 20 participants each) will receive therapy-based interventions in addition to the standard of care, and the remaining control group (CG, 20 participants) will receive the standard of care and no additional therapy. Current standard of care regarding stroke inpatients requires admission to Johns Hopkins Comprehensive Stroke Center. At discharge, depending upon the stroke severity, patients can either be discharged to a facility or to home. This study is specifically targeting patients discharged to home. Importantly, patients going home are followed in the Joint Stroke Transitional Technology-Enhanced Program (JSTTEP). JSTTEP is the standard of care, inter-disciplinary, telemedicine program that operates during the first month after stroke to facilitate the patient's transition from hospital to home. Each shared visit includes a physician and therapist evaluation and combined treatment plan. A single multidisciplinary online group education session is completed within 1 month after stoke hospitalization and is open to patients and care partners. Stroke patients who are being discharged home from the Johns Hopkins Comprehensive Stroke Center via JSTTEP are eligible for participation in this study. A consecutive series of patients who meet inclusion criteria will be approached for consent to participate in this study. Inclusion (or exclusion) will be determined using the criteria described in the Inclusion/Exclusion Criteria Section, using a HIPAA Privacy Authorization Form. Upon consenting to participate in the study, each participant will undergo a Baseline Assessment visit, while still an inpatient, composed of a gaming, functional, and cognitive assessments (described below under Baseline Assessment). These assessments also work as screenings; that is, if, after signing the consent and during the enrollment process, a patient fails to meet enrollment criteria, the investigators can halt enrollment. Similarly, if a patient does meet the enrollment criteria, the participants will be assigned into a treatment group (as described below in the Randomization Section), and will receive instructions according to the participants group

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hand Weakness
Keywords
stroke, stroke recovery, hand weakness, video game

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm G1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Treatment Arm G2
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group (CG)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
NoNo
Intervention Description
Participants in the G2 group will use the Twirlstone (knob-like) device to play a videogame called Nono's World. The Twirlstone is an electromechanical device that resembles a knob and a standard joystick (identical to the discontinued Atari CX-20 Controller). The knob can rotate or move in a push-pull fashion. To control the game's character (an axolotl called Nono), a signal about the knob motion is relayed to the computer wirelessly. This device has been certified by Johns Hopkins University's Clinical Engineering Services, where it was deemed less than minimum risk. The game has been custom built to allow participants to take control of the character using subtle manipulative finger movements to accomplish game-like tasks. The investigators will use portable communication devices to carry out telemedicine sessions. All devices and are low-power battery-operated tools for encouraging hand movement and the components are approved for use in the commercial market.
Intervention Type
Behavioral
Intervention Name(s)
occupational therapy - self directed
Intervention Description
Participants 5 daily sessions over 3 weeks consisting of self-administered, unsupervised occupational therpay. Additionally, participants will have 2, <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. The investigators will use portable communication devices for the purposes of carrying out telemedicine sessions. All devices and are low-power battery-operated tools for encouraging hand movement and the components are approved for use in the commercial market.
Primary Outcome Measure Information:
Title
Change in finger dexterity as assessed by the nine-hole peg test (9PHT)
Description
The Nine-Hole Peg Test (9HPT) is used to measure finger dexterity in patients with various neurological diagnoses. Participants are asked to place pegs into the holes one at a time, then remove them one at a time, and place them back in the container as fast as they can.
Time Frame
Baseline, post-intervention up to 7 days, 6 months post-stroke
Secondary Outcome Measure Information:
Title
Change in arm hand function using the Fugl Meyer Scale.
Description
Change in arm and hand function at the impairment level as assessed by the Fugl Meyer Upper Extremity Assessment of motor control (FM-UE). The FM-UE uses a 3-point ordinal scale to evaluate sensorimotor function of the arm and hand of the affected upper extremity during reach and grasp movements in and out of synergistic movement patterns
Time Frame
Baseline, up to 7 days post-intervention, and 6 months post-stroke
Title
Change in arm and hand function using the ARAT
Description
Change in arm and hand function at the activity level as assessed by the Action Research Arm Test (ARAT). The ARAT is a 19-item measure with 4 subtests (grip, grasp, pinch, and gross arm movement) and 57 possible points. Each subtest has tasks varying in complexity that are graded using a 4-point ordinal scale to describe if tasks are completed with normal movement, movement that requires increased time, are partially completed, or unable to be completed.
Time Frame
Baseline, up to 7 days post-intervention, and 6 months post-stroke
Title
Change in fingertip individuation index as assessed by the Cyber Glove
Description
Change in fingertip individuation index as assessed by kinematic measurement of digit movement using the CyberGlove. The Cyberglove is a wearable device that uses sensor-based technology to capture joint range of motion. Full extension and flexion of each digit in isolation will be captured using this technology.
Time Frame
Baseline, up to 7 days post-intervention, and 6 months post-stroke
Title
Change in Cognitive impairment as assessed by Montreal Cognitive Assessment (MOCA)
Description
Montreal Cognitive Assessment (MOCA) will be used. The MOCA is a screening assessment for mild cognitive impairment. It has 30 questions that assess different domains of cognition including: executive functions, memory, language, attention, and abstract reasoning.
Time Frame
Baseline, up to 7 days post-intervention, and 6 months post-stroke
Title
Engagement and enjoyment of the different sub-aspects within each additional therapy approach as assessed by satisfaction surveys developed by the study team
Description
Engagement and enjoyment of the different sub-aspects within each additional therapy approach as assessed by satisfaction surveys which will contain a combination of questions including Likert scale-based questions, ordinal questions, and fill-in-the-blank questions (the study team will create this survey specific for this study.
Time Frame
up to 7 days post--intervention
Title
Change in disability as assessed by the modified Rankin score
Description
Change in disability as assessed by the modified Rankin Scale (mRS). The mRS is a widely used clinician reported , single-item measure of global disability
Time Frame
Baseline, up to 7 days pot-intervention, and 6 months post-stroke

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Arm impairment that is too severe (FM-UE < 40) on day of baseline testing prior to beginning of the study. Recent Botox injection to upper limb (since stroke onset). 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). Terminal illness with life expectancy < 6 months. Inability to sit in a chair and perform hand exercises for 20 minutes at the time. Cognitive impairment, with score on Montreal Cognitive Assessment (MoCA) ≤ 20. Social and/or personal circumstances that prevent telemedicine follow-up.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steven R. Zeiler, M.D., Ph.D.
Phone
3035207404
Email
sz@jhmi.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Arnold Gomez, Ph.D.
Email
adgomez@jhu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven R Zeiler, M.D, Ph.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkin
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-6953
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven R Zeiler, MD, PhD
Phone
303-520-7404
Email
sz@jhmi.edu

12. IPD Sharing Statement

Plan to Share IPD
No
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Self-Administered Gaming and Exercise at Home (SAGEH)

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