Liselot Thijs1, Eline Voets1, Evelien Wiskerke1,2, Thomas Nauwelaerts3, Yves Arys3, Harold Haspeslagh3, Jan Kool2, Patrick Bischof4, Christoph Bauer5, Robin Lemmens6,7,8, Daniel Baumgartner9, Geert Verheyden1. 1. Department of Rehabilitation Sciences, KU Leuven - University of Leuven, Leuven, Belgium. 2. Department of Physiotherapy, Kliniken Valens, Valens, Switzerland. 3. NiniX Technologies, Bruges, Belgium. 4. IMES Institute of Mechanical Systems, ZHAW School of Engineering, Winterthur, Switzerland. 5. Institute of Physiotherapy, ZHAW School of Health Professions, Forschungsschwerpunkt Biomechanical Engineering, Technikumstrasse 9, 8400, Winterthur, Switzerland. 6. Center for Brain & Disease Research, Laboratory of Neurobiology, VIB, Leuven, Belgium. 7. Department of Neurology, University Hospitals Leuven, Leuven, Belgium. 8. Department of Neurosciences, Experimental Neurology, and Leuven Brain Institute (LBI), KU Leuven - University of Leuven, Leuven, Belgium. 9. IMES Institute of Mechanical Systems, ZHAW School of Engineering, Winterthur, Switzerland. daniel.baumgartner@zhaw.ch.
Abstract
BACKGROUND: Technology development for sitting balance therapy and trunk rehabilitation is scarce. Hence, intensive one-to-one therapist-patient training is still required. We have developed a novel rehabilitation prototype, specifically aimed at providing sitting balance therapy. We investigated whether technology-supported sitting balance training was feasible and safe in chronic stroke patients and we determined whether clinical outcomes improved after a four-week programme, compared with usual care. METHODS: In this parallel-group, assessor-blinded, randomized controlled pilot trial, we divided first-event chronic stroke participants into two groups. The experimental group received usual care plus additional therapy supported by rehabilitation technology, consisting of 12 sessions of 50 min of therapy over four weeks. The control group received usual care only. We assessed all participants twice pre-intervention and once post-intervention. Feasibility and safety were descriptively analysed. Between-group analysis evaluated the pre-to-post differences in changes in motor and functional outcomes. RESULTS: In total, 30 participants were recruited and 29 completed the trial (experimental group: n = 14; control group: n = 15). There were no between-group differences at baseline. Therapy was evaluated as feasible by participants and therapist. There were no serious adverse events during sitting balance therapy. Changes in clinical outcomes from pre- to post-intervention demonstrated increases in the experimental than in the control group for: sitting balance and trunk function, evaluated by the Trunk Impairment Scale (mean points score (SD) 7.07 (1.69) versus 0.33 (2.35); p < 0.000); maximum gait speed, assessed with the 10 Metre Walk Test (mean gait speed 0.16 (0.16) m/s versus 0.06 (0.06) m/s; p = 0.003); and functional balance, measured using the Berg balance scale (median points score (IQR) 4.5 (5) versus 0 (4); p = 0.014). CONCLUSIONS:Technology-supported sitting balance training in persons with chronic stroke is feasible and safe. A four-week, 12-session programme on top of usual care suggests beneficial effects for trunk function, maximum gait speed and functional balance. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04467554, https://clinicaltrials.gov/ct2/show/NCT04467554 , date of Registration: 13 July 2020.
RCT Entities:
BACKGROUND: Technology development for sitting balance therapy and trunk rehabilitation is scarce. Hence, intensive one-to-one therapist-patient training is still required. We have developed a novel rehabilitation prototype, specifically aimed at providing sitting balance therapy. We investigated whether technology-supported sitting balance training was feasible and safe in chronic strokepatients and we determined whether clinical outcomes improved after a four-week programme, compared with usual care. METHODS: In this parallel-group, assessor-blinded, randomized controlled pilot trial, we divided first-event chronic strokeparticipants into two groups. The experimental group received usual care plus additional therapy supported by rehabilitation technology, consisting of 12 sessions of 50 min of therapy over four weeks. The control group received usual care only. We assessed all participants twice pre-intervention and once post-intervention. Feasibility and safety were descriptively analysed. Between-group analysis evaluated the pre-to-post differences in changes in motor and functional outcomes. RESULTS: In total, 30 participants were recruited and 29 completed the trial (experimental group: n = 14; control group: n = 15). There were no between-group differences at baseline. Therapy was evaluated as feasible by participants and therapist. There were no serious adverse events during sitting balance therapy. Changes in clinical outcomes from pre- to post-intervention demonstrated increases in the experimental than in the control group for: sitting balance and trunk function, evaluated by the Trunk Impairment Scale (mean points score (SD) 7.07 (1.69) versus 0.33 (2.35); p < 0.000); maximum gait speed, assessed with the 10 Metre Walk Test (mean gait speed 0.16 (0.16) m/s versus 0.06 (0.06) m/s; p = 0.003); and functional balance, measured using the Berg balance scale (median points score (IQR) 4.5 (5) versus 0 (4); p = 0.014). CONCLUSIONS: Technology-supported sitting balance training in persons with chronic stroke is feasible and safe. A four-week, 12-session programme on top of usual care suggests beneficial effects for trunk function, maximum gait speed and functional balance. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04467554, https://clinicaltrials.gov/ct2/show/NCT04467554 , date of Registration: 13 July 2020.
Authors: R P S Van Peppen; G Kwakkel; S Wood-Dauphinee; H J M Hendriks; Ph J Van der Wees; J Dekker Journal: Clin Rehabil Date: 2004-12 Impact factor: 3.477
Authors: Michelle C Haas; Bettina B Sommer; Samuel Karrer; Matthias Jörger; Eveline S Graf; Martin Huber; Daniel Baumgartner; Jens Bansi; Jan Kool; Christoph M Bauer Journal: PLoS One Date: 2022-07-29 Impact factor: 3.752