Technology-supported sitting balance therapy versus usual care in the chronic stage after stroke: a pilot randomized controlled trial

Liselot Thijs, Eline Voets, Evelien Wiskerke, Thomas Nauwelaerts, Yves Arys, Harold Haspeslagh, Jan Kool, Patrick Bischof, Christoph Bauer, Robin Lemmens, Daniel Baumgartner, Geert Verheyden, Liselot Thijs, Eline Voets, Evelien Wiskerke, Thomas Nauwelaerts, Yves Arys, Harold Haspeslagh, Jan Kool, Patrick Bischof, Christoph Bauer, Robin Lemmens, Daniel Baumgartner, Geert Verheyden

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://ichgcp.net/clinical-trials-registry/NCT04467554 , date of Registration: 13 July 2020.

Keywords: Feasibility; Randomized Controlled Trial; Sitting Balance; Stroke; Technology-supported; Trunk Rehabilitation.

Conflict of interest statement

LT, EV, EW, JK, TN, PB, CB declared no competing interest. GV and DB received Eurostars funding (Project ID 11323) as academic partners in the project, GV received Promobilia funding (Ref. 20062) for conducting this clinical trial. DB, YA and HH received Eurostars funding (Project ID 11323) as industrial partners in the project. DB, YA, HH declared holding stocks or shares in an organization that may in any way gain or lose financially from the publication of the manuscript, either now or in the future and receiving reimbursements, fees, funding, or salary from an organization that holds or has applied for patents relating to the content of the manuscript.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
T-Chair prototype and main components
Fig. 2
Fig. 2
Screenshots of boat game exercise: boat game (left) the participant has to navigate the boat through weight distribution to the left to catch the arrows and then move the boat at the port. Boat game (right), the participant is on the left side of the canal, against the bank, and by weight distribution, the participant can move the boat to the right where a new target is located
Fig. 3
Fig. 3
Diagram of the control architecture
Fig. 4
Fig. 4
CONSORT flow diagram outlining the distribution of the study participants
Fig. 5
Fig. 5
Left: Total TIS score evolution over time (Mean and SD). Middle: Maximum gait speed evolution over time (Mean and SD); Right: Functional balance evolution over time (Median and IQR)

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