Clinical trial NCT05929027: Self-Administered Gaming and Exercise at Home (SAGEH)
Official title: Self-Administered Gaming and Exercise at Home (SAGEH)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Hand Weakness
Keywords: stroke
stroke recovery
hand weakness
video game
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Sheikh Khalifa Stroke Institute
First posted: 2023-07-03
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

1. Age 21 years and over
2. Stroke confirmed by CT or MRI within the previous 6 weeks.
3. Arm and/or hand impairment induced by the stroke.
4. Meet JSTTEP criteria and are enrolled in JSTTEP.
5. Admitted to the Johns Hopkins Hospital (JHH) inpatient stroke service.
6. Proficient in speaking and reading English.
7. Willing and capable to contacted remotely for all necessary telemedicine contacts.
8. No history of prior ischemic or hemorrhagic stroke with associated motor deficits (prior stroke with no upper limb motor symptoms is allowed)
9. Ability to give informed consent.

Exclusion Criteria:

1. Arm impairment that is too severe (FM-UE \< 40) on day of baseline testing prior to beginning of the study.
2. Recent Botox injection to upper limb (since stroke onset).
3. 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).
4. Terminal illness with life expectancy \< 6 months.
5. Inability to sit in a chair and perform hand exercises for 20 minutes at the time.
6. Cognitive impairment, with score on Montreal Cognitive Assessment (MoCA) ≤ 20.
7. Social and/or personal circumstances that prevent telemedicine follow-up.

Primary outcomes:
measure: Change in finger dexterity as assessed by the nine-hole peg test (9PHT)
timeFrame: Baseline, post-intervention up to 7 days, 6 months post-stroke
Secondary outcomes:
measure: Change in arm hand function using the Fugl Meyer Scale.
timeFrame: Baseline, up to 7 days post-intervention, and 6 months post-stroke
measure: Change in arm and hand function using the ARAT
timeFrame: Baseline, up to 7 days post-intervention, and 6 months post-stroke
measure: Change in fingertip individuation index as assessed by the Cyber Glove
timeFrame: Baseline, up to 7 days post-intervention, and 6 months post-stroke
measure: Change in Cognitive impairment as assessed by Montreal Cognitive Assessment (MOCA)
timeFrame: Baseline, up to 7 days post-intervention, and 6 months post-stroke
measure: Engagement and enjoyment of the different sub-aspects within each additional therapy approach as assessed by satisfaction surveys developed by the study team
timeFrame: up to 7 days post--intervention
measure: Change in disability as assessed by the modified Rankin score
timeFrame: Baseline, up to 7 days pot-intervention, and 6 months post-stroke
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkin
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Steven R Zeiler, M.D, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Heron M. Deaths: Leading Causes for 2019. Natl Vital Stat Rep. 2021 Jul;70(9):1-114.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Barry AJ, Triandafilou KM, Stoykov ME, Bansal N, Roth EJ, Kamper DG. Survivors of Chronic Stroke Experience Continued Impairment of Dexterity But Not Strength in the Nonparetic Upper Limb. Arch Phys Med Rehabil. 2020 Jul;101(7):1170-1175. doi: 10.1016/j.apmr.2020.01.018. Epub 2020 Feb 28.
citation: Krakauer JW, Kitago T, Goldsmith J, Ahmad O, Roy P, Stein J, Bishop L, Casey K, Valladares B, Harran MD, Cortes JC, Forrence A, Xu J, DeLuzio S, Held JP, Schwarz A, Steiner L, Widmer M, Jordan K, Ludwig D, Moore M, Barbera M, Vora I, Stockley R, Celnik P, Zeiler S, Branscheidt M, Kwakkel G, Luft AR. Comparing a Novel Neuroanimation Experience to Conventional Therapy for High-Dose Intensive Upper-Limb Training in Subacute Stroke: The SMARTS2 Randomized Trial. Neurorehabil Neural Repair. 2021 May;35(5):393-405. doi: 10.1177/15459683211000730. Epub 2021 Mar 20.
citation: Murphy TH, Corbett D. Plasticity during stroke recovery: from synapse to behaviour. Nat Rev Neurosci. 2009 Dec;10(12):861-72. doi: 10.1038/nrn2735. Epub 2009 Nov 4.
citation: Winstein CJ, Stein J, Arena R, Bates B, Cherney LR, Cramer SC, Deruyter F, Eng JJ, Fisher B, Harvey RL, Lang CE, MacKay-Lyons M, Ottenbacher KJ, Pugh S, Reeves MJ, Richards LG, Stiers W, Zorowitz RD; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Quality of Care and Outcomes Research. Guidelines for Adult Stroke Rehabilitation and Recovery: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2016 Jun;47(6):e98-e169. doi: 10.1161/STR.0000000000000098. Epub 2016 May 4.
citation: BENNETT EL, DIAMOND MC, KRECH D, ROSENZWEIG MR. CHEMICAL AND ANATOMICAL PLASTICITY BRAIN. Science. 1964 Oct 30;146(3644):610-9. doi: 10.1126/science.146.3644.610. No abstract available.
citation: McDonald MW, Hayward KS, Rosbergen ICM, Jeffers MS, Corbett D. Is Environmental Enrichment Ready for Clinical Application in Human Post-stroke Rehabilitation? Front Behav Neurosci. 2018 Jul 11;12:135. doi: 10.3389/fnbeh.2018.00135. eCollection 2018.
citation: Vive S, Af Geijerstam JL, Kuhn HG, Bunketorp-Kall L. Enriched, Task-Specific Therapy in the Chronic Phase After Stroke: An Exploratory Study. J Neurol Phys Ther. 2020 Apr;44(2):145-155. doi: 10.1097/NPT.0000000000000309.
citation: Platz T. Impairment-oriented training (IOT)--scientific concept and evidence-based treatment strategies. Restor Neurol Neurosci. 2004;22(3-5):301-15.
citation: Platz T, Lotze M. Arm Ability Training (AAT) Promotes Dexterity Recovery After a Stroke-a Review of Its Design, Clinical Effectiveness, and the Neurobiology of the Actions. Front Neurol. 2018 Dec 11;9:1082. doi: 10.3389/fneur.2018.01082. eCollection 2018.
citation: Krakauer JW, Cortes JC. A non-task-oriented approach based on high-dose playful movement exploration for rehabilitation of the upper limb early after stroke: A proposal. NeuroRehabilitation. 2018;43(1):31-40. doi: 10.3233/NRE-172411.
citation: Schieber MH, Santello M. Hand function: peripheral and central constraints on performance. J Appl Physiol (1985). 2004 Jun;96(6):2293-300. doi: 10.1152/japplphysiol.01063.2003.
citation: Elliott JM, Connolly KJ. A classification of manipulative hand movements. Dev Med Child Neurol. 1984 Jun;26(3):283-96. doi: 10.1111/j.1469-8749.1984.tb04445.x.
citation: Xu J, Ejaz N, Hertler B, Branscheidt M, Widmer M, Faria AV, Harran MD, Cortes JC, Kim N, Celnik PA, Kitago T, Luft AR, Krakauer JW, Diedrichsen J. Separable systems for recovery of finger strength and control after stroke. J Neurophysiol. 2017 Aug 1;118(2):1151-1163. doi: 10.1152/jn.00123.2017. Epub 2017 May 31.
citation: Raghavan P, Santello M, Gordon AM, Krakauer JW. Compensatory motor control after stroke: an alternative joint strategy for object-dependent shaping of hand posture. J Neurophysiol. 2010 Jun;103(6):3034-43. doi: 10.1152/jn.00936.2009. Epub 2010 Mar 24.
citation: Patel P, Kaingade SR, Wilcox A, Lodha N. Force control predicts fine motor dexterity in high-functioning stroke survivors. Neurosci Lett. 2020 Jun 11;729:135015. doi: 10.1016/j.neulet.2020.135015. Epub 2020 Apr 30.
citation: Karni A, Meyer G, Rey-Hipolito C, Jezzard P, Adams MM, Turner R, Ungerleider LG. The acquisition of skilled motor performance: fast and slow experience-driven changes in primary motor cortex. Proc Natl Acad Sci U S A. 1998 Feb 3;95(3):861-8. doi: 10.1073/pnas.95.3.861.
citation: Cramer SC, Dodakian L, Le V, See J, Augsburger R, McKenzie A, Zhou RJ, Chiu NL, Heckhausen J, Cassidy JM, Scacchi W, Smith MT, Barrett AM, Knutson J, Edwards D, Putrino D, Agrawal K, Ngo K, Roth EJ, Tirschwell DL, Woodbury ML, Zafonte R, Zhao W, Spilker J, Wolf SL, Broderick JP, Janis S; National Institutes of Health StrokeNet Telerehab Investigators. Efficacy of Home-Based Telerehabilitation vs In-Clinic Therapy for Adults After Stroke: A Randomized Clinical Trial. JAMA Neurol. 2019 Sep 1;76(9):1079-1087. doi: 10.1001/jamaneurol.2019.1604.
citation: Raglio A, Panigazzi M, Colombo R, Tramontano M, Iosa M, Mastrogiacomo S, Baiardi P, Molteni D, Baldissarro E, Imbriani C, Imarisio C, Eretti L, Hamedani M, Pistarini C, Imbriani M, Mancardi GL, Caltagirone C. Hand rehabilitation with sonification techniques in the subacute stage of stroke. Sci Rep. 2021 Mar 31;11(1):7237. doi: 10.1038/s41598-021-86627-y.
citation: Unibaso-Markaida I, Iraurgi I, Ortiz-Marques N, Amayra I, Martinez-Rodriguez S. Effect of the Wii Sports Resort on the improvement in attention, processing speed and working memory in moderate stroke. J Neuroeng Rehabil. 2019 Feb 28;16(1):32. doi: 10.1186/s12984-019-0500-5.
citation: Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
citation: Tariq SH, Tumosa N, Chibnall JT, Perry MH 3rd, Morley JE. Comparison of the Saint Louis University mental status examination and the mini-mental state examination for detecting dementia and mild neurocognitive disorder--a pilot study. Am J Geriatr Psychiatry. 2006 Nov;14(11):900-10. doi: 10.1097/01.JGP.0000221510.33817.86.
citation: Reuben DB, Magasi S, McCreath HE, Bohannon RW, Wang YC, Bubela DJ, Rymer WZ, Beaumont J, Rine RM, Lai JS, Gershon RC. Motor assessment using the NIH Toolbox. Neurology. 2013 Mar 12;80(11 Suppl 3):S65-75. doi: 10.1212/WNL.0b013e3182872e01.
citation: Wilson PH, Rogers JM, Vogel K, Steenbergen B, McGuckian TB, Duckworth J. Home-based (virtual) rehabilitation improves motor and cognitive function for stroke patients: a randomized controlled trial of the Elements (EDNA-22) system. J Neuroeng Rehabil. 2021 Nov 25;18(1):165. doi: 10.1186/s12984-021-00956-7.
citation: Beebe JA, Lang CE. Relationships and responsiveness of six upper extremity function tests during the first six months of recovery after stroke. J Neurol Phys Ther. 2009 Jun;33(2):96-103. doi: 10.1097/NPT.0b013e3181a33638.
citation: Schneider EJ, Ada L, Lannin NA. Extra upper limb practice after stroke: a feasibility study. Pilot Feasibility Stud. 2019 Dec 30;5:156. doi: 10.1186/s40814-019-0531-5. eCollection 2019.
citation: Heshmatollah A, Dommershuijsen LJ, Fani L, Koudstaal PJ, Ikram MA, Ikram MK. Long-term trajectories of decline in cognition and daily functioning before and after stroke. J Neurol Neurosurg Psychiatry. 2021 Nov;92(11):1158-1163. doi: 10.1136/jnnp-2021-326043. Epub 2021 Jul 6.
citation: Heller A, Wade DT, Wood VA, Sunderland A, Hewer RL, Ward E. Arm function after stroke: measurement and recovery over the first three months. J Neurol Neurosurg Psychiatry. 1987 Jun;50(6):714-9. doi: 10.1136/jnnp.50.6.714.