Multicentre, single-blind randomised controlled trial comparing MyndMove neuromodulation therapy with conventional therapy in traumatic spinal cord injury: a protocol study.

Autor:	Anderson KD; Department of Physical Medicine and Rehabilitation, MetroHealth System, Cleveland, Ohio, USA.; Department of Physical Medicine and Rehabilitation, Case Western Reserve University, Cleveland, Ohio, USA., Wilson JR; Department of Physical Medicine and Rehabilitation, MetroHealth System, Cleveland, Ohio, USA.; Department of Physical Medicine and Rehabilitation, Case Western Reserve University, Cleveland, Ohio, USA., Korupolu R; Department of Physical Medicine and Rehabilitation, University of Texas Health Science Center at Houston, Houston, Texas, USA.; The Institute for Rehabilitation and Research (TIRR), Houston, Texas, USA., Pierce J; Centre for Neurology Studies, Health Tech Connex, Surrey, British Columbia, Canada., Bowen JM; Department of Health Research Methods, Evidence, and Impact, McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada.; Toronto Health Economics and Technology Assessment (THETA) Collaborative, University of Toronto, Toronto, Ontario, Canada., O'Reilly D; Department of Health Research Methods, Evidence, and Impact, McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada.; TELUS Health, Toronto, Ontario, Canada., Kapadia N; Toronto Rehabilitation Institute, University Health Network, Toronto, Ontario, Canada.; Department of Physical Therapy, University of Toronto, Toronto, Ontario, Canada., Popovic MR; The KITE Research Institute, University Health Network, Toronto, Ontario, Canada.; Institute of Biomaterials and Biomedical Engineering, University of Toronto, Toronto, Ontario, Canada., Thabane L; Department of Health Research Methods, Evidence, and Impact, McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada.; Biostatistics Unit, St. Joseph's Healthcare, Hamilton, Ontario, Canada., Musselman KE; Toronto Rehabilitation Institute, University Health Network, Toronto, Ontario, Canada Kristin.Musselman@uhn.ca.; Department of Physical Therapy, University of Toronto, Toronto, Ontario, Canada.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2020 Sep 28; Vol. 10 (9), pp. e039650. Date of Electronic Publication: 2020 Sep 28.
DOI:	10.1136/bmjopen-2020-039650
Abstrakt:	Introduction: This protocol is describing a multicentre, single-blind randomised controlled trial. The objective is to compare the efficacy of MyndMove therapy versus conventional therapy (CT) in improving upper extremity function in individuals with C4-C7 traumatic, incomplete spinal cord injury (SCI). It is being conducted in two US and two Canadian SCI rehabilitation centres. Methods and Analysis: Sixty people aged 18 years or older with a C4-C7 incomplete (AIS B-D) SCI between 4 months and 8 years postinjury are randomised to receive 40 sessions of MyndMove neuromodulation therapy or CT within a 14-week period of time. Therapy sessions are 1 hour in duration with a dose of 3-5 sessions per week. Assessments occur prior to randomisation, after 20 sessions, after 40 sessions and 10 weeks after the last session. The primary outcome measure is the efficacy of MyndMove therapy versus CT in improving upper extremity function as measured by Spinal Cord Independence Measure III: Self-Care subscore after 40 sessions. Secondary outcomes include: (1) improvements in the SCIM mobility subscore; (2) upper limb functions measured by Graded Redefined Assessment of Strength, Sensibility and Prehension and (3) Toronto Rehab Institute Hand Function Test; (4) To assess safety as measured by serious and non-serious adverse events recorded for participants in both groups of the study population over the duration of the study; (5) to compare the change in quality of life as measured by the Spinal Cord Injury-Quality of Life; and (6) to evaluate the impact on healthcare resource utilisation. Ethics and Dissemination: All ethical approvals were obtained prior to enrolling any participants. Dissemination of the results of the study will be made at peer-reviewed academic meetings and through peer-reviewed medical journals TRIAL REGISTRATION NUMBER: NCT03439319. Competing Interests: Competing interests: MyndTec Inc is the contracting organisation of this study and through funding provided by US Army Medical Research and Materiel Command, researchers are reimbursed for doing this study. All investigators have an interest in completing the study. (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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