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Higher Doses of Intensive Upper Limb Rehabilitation for Moderate to Severe Impairment in Acute, Subacute Stroke: Phase I Dose Escalation Study

Triccas, Lisa Tedesco; Hallet, Peter; Cardeynaels, Sofie; Ward, Nick; Bertels, Nele; Thijs, Liselot; Lejeune, Thierry; ... Feys, Peter; + view all (2025) Higher Doses of Intensive Upper Limb Rehabilitation for Moderate to Severe Impairment in Acute, Subacute Stroke: Phase I Dose Escalation Study. Neurorehabilitation and Neural Repair 10.1177/15459683251338797. (In press). Green open access

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Abstract

BACKGROUND: Optimizing moderate to severe upper limb recovery is likely to require a higher dose of rehabilitation training than is currently delivered, but the feasibility and acceptability of higher dose regimes is unclear in the early-stage post stroke. Objective: To determine the maximum time spent on upper limb rehabilitation in people with moderate to severe impairment in acute and early sub-acute stage of stroke, in a phase I dose-escalation study. METHODS: Participants were recruited using a 3+3 study design from 2 stroke units and rehabilitation centers in Belgium. Patients received standard care plus escalating doses of upper limb motor training at 4 dose time-on-task levels: 1 (40 minutes), 2 (67 minutes), 3 (100 minutes) and 4 (133 minutes). Treatment was provided for 3 daily sessions, starting with 3 participants at level 1 and if dose was completed based on dose-limiting toxicity criteria, it was escalated to the next level with 3 new participants. RESULTS: Eighteen participants were recruited (median days post-stroke: 7.5 [Q1:5; Q3: 23.3]) with a mean Fugl Meyer Assessment Upper Extremity score of 29.4 (SD: 11.2). The maximum tolerated time-on-task of upper limb rehabilitation was, 100 minutes per day, with an additional 35 minutes of routine upper limb therapy provided as part of standard care. Level of fatigue and rate of perceived exertion were highest at dose level 4, resulting in participants not completing the dose of 133 minutes. CONCLUSIONS: Confirmative with existing literature using a different intervention, individuals with moderate to severe impairment in the early-stage of stroke, can tolerate higher doses of upper limb rehabilitation than those typically administered in standard care. These findings support future investigation into phase I/IIa dose-finding clinical trials exploring long-duration, high-intensity upper limb rehabilitation programs in the early post-stroke period. REGISTRATION: NCT04973553 (July 22, 2021). https://classic. CLINICALTRIALS: gov/ct2/show/NCT04973553.

Type: Article
Title: Higher Doses of Intensive Upper Limb Rehabilitation for Moderate to Severe Impairment in Acute, Subacute Stroke: Phase I Dose Escalation Study
Location: United States
Open access status: An open access version is available from UCL Discovery
DOI: 10.1177/15459683251338797
Publisher version: https://doi.org/10.1177/15459683251338797
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
Keywords: Arm and hand movement, cerebrovascular accident, functional electrical stimulation, session length, time-on-task, upper limb motor rehabilitation
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > UCL Queen Square Institute of Neurology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > UCL Queen Square Institute of Neurology > Clinical and Movement Neurosciences
URI: https://discovery.ucl.ac.uk/id/eprint/10212073
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