Improving gait adaptability in patients with hereditary spastic paraplegia (Move-HSP): study protocol for a randomized controlled trial

Autor: van de Venis, Lotte; van de Warrenburg, Bart P. C.; Weerdesteyn, Vivian; van Lith, Bas J. H.; Geurts, Alexander C. H.; Nonnekes, Jorik
Sprache: Englisch
Veröffentlicht: 2021
Quelle: PubMed Central (PMC)
Online Zugang: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7788541/
http://dx.doi.org/10.1186/s13063-020-04932-9
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7788541/
https://doi.org/10.1186/s13063-020-04932-9
Erfassungsnummer: ftpubmed:oai:pubmedcentral.nih.gov:7788541

Zusammenfassung

BACKGROUND: People with hereditary spastic paraplegia (HSP) experience difficulties adapting their gait to meet environmental demands, a skill required for safe and independent ambulation. Gait adaptability training is possible on the C-Mill, a treadmill equipped with augmented reality, enabling visual projections to serve as stepping targets or obstacles. It is unknown whether gait adaptability can be trained in people with HSP. AIM: The aim of Move-HSP is to study the effects of ten 1-h sessions of C-Mill training, compared with usual care, on gait adaptability in people with pure HSP. In addition, this study aims to identify key determinants of C-Mill training efficacy in people with pure HSP. METHOD: Move-HSP is a 5-week, two-armed, open-label randomized controlled trial with a cross-over design for the control group. Thirty-six participants with pure HSP will be included. After signing informed consent, participants are randomized (1:1) to intervention or control group. All participants register (near) falls for 15 weeks, followed by the first assessment (week 16), and, thereafter, wear an Activ8 activity monitor for 7 days (week 16). The intervention group receives 10 sessions of C-Mill training (twice per week, 1-h sessions; weeks 17–21), whereas control group continues with usual care (weeks 17–21). Afterwards, both groups are re-assessed (week 22). Subsequently, the intervention group enter follow-up, whereas control group receives 10 sessions of C-Mill training (weeks 23–27), is re-assessed (week 28), and enters follow-up. During follow-up, both groups wear Activ8 activity monitors for 7 days (intervention group: week 23, control group: week 29) and register (near) falls for 15 weeks (intervention group: weeks 23–37, control group: weeks 29–43), before the final assessment (intervention group: week 38, control group: week 44). The primary outcome is the obstacle subtask of the Emory Functional Ambulation Profile. Secondary outcomes consist of clinical tests assessing balance and walking capacity, ...