Self-Administered Gaming and Exercise at Home (SAGEH)

Overview

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

Interventions

• Behavioral NoNo
  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'
• Behavioral occupational therapy - self directed
  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 p

Primary outcome measures

• Change in finger dexterity as assessed by the nine-hole peg test (9PHT) [Time frame: Baseline, post-intervention up to 7 days, 6 months post-stroke]

Secondary outcome measures (6)

• Change in arm hand function using the Fugl Meyer Scale. [Time frame: Baseline, up to 7 days post-intervention, and 6 months post-stroke]
• Change in arm and hand function using the ARAT [Time frame: Baseline, up to 7 days post-intervention, and 6 months post-stroke]
• Change in fingertip individuation index as assessed by the Cyber Glove [Time frame: Baseline, up to 7 days post-intervention, and 6 months post-stroke]
• Change in Cognitive impairment as assessed by Montreal Cognitive Assessment (MOCA) [Time frame: Baseline, up to 7 days post-intervention, and 6 months post-stroke]
• Engagement and enjoyment of the different sub-aspects within each additional therapy approach as assessed by satisfaction surveys developed by the study team [Time frame: up to 7 days post--intervention]
• Change in disability as assessed by the modified Rankin score [Time frame: Baseline, up to 7 days pot-intervention, and 6 months post-stroke]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Johns Hopkin — Baltimore

Publications

• Johansson GM, Hager CK. A modified standardized nine hole peg test for valid and reliable kinematic assessment of dexterity post-stroke. J Neuroeng Rehabil. 2019 Jan 14;16(1):8. doi: 10.1186/s12984-019-0479-y. PMID 30642350
• Bejot Y, Daubail B, Giroud M. Epidemiology of stroke and transient ischemic attacks: Current knowledge and perspectives. Rev Neurol (Paris). 2016 Jan;172(1):59-68. doi: 10.1016/j.neurol.2015.07.013. Epub 2015 Dec 21. PMID 26718592
• Heron M. Deaths: Leading Causes for 2019. Natl Vital Stat Rep. 2021 Jul;70(9):1-114. PMID 34520342
• Brunnstrom S. Motor testing procedures in hemiplegia: based on sequential recovery stages. Phys Ther. 1966 Apr;46(4):357-75. doi: 10.1093/ptj/46.4.357. No abstract available. PMID 5907254
• Nakayama H, Jorgensen HS, Raaschou HO, Olsen TS. Recovery of upper extremity function in stroke patients: the Copenhagen Stroke Study. Arch Phys Med Rehabil. 1994 Apr;75(4):394-8. doi: 10.1016/0003-9993(94)90161-9. PMID 8172497
• Kotila M, Waltimo O, Niemi ML, Laaksonen R, Lempinen M. The profile of recovery from stroke and factors influencing outcome. Stroke. 1984 Nov-Dec;15(6):1039-44. doi: 10.1161/01.str.15.6.1039. PMID 6506115
• Colebatch JG, Gandevia SC. The distribution of muscular weakness in upper motor neuron lesions affecting the arm. Brain. 1989 Jun;112 ( Pt 3):749-63. doi: 10.1093/brain/112.3.749. PMID 2731028
• Jebsen RH, Taylor N, Trieschmann RB, Trotter MJ, Howard LA. An objective and standardized test of hand function. Arch Phys Med Rehabil. 1969 Jun;50(6):311-9. No abstract available. PMID 5788487

Identifiers

NCT: NCT05929027 · IRB00340964

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗