Corien Dm Nikamp1,2, Jaap H Buurke1,3, Job van der Palen4,5, Hermie J Hermens1,3, Johan S Rietman1,2,6. 1. 1 Roessingh Research and Development, Enschede, The Netherlands. 2. 2 Department of Biomechanical Engineering, MIRA Institute for Biomedical Technology and Technical Medicine, University of Twente, Enschede, The Netherlands. 3. 3 Department of Biomedical Signals and Systems, University of Twente, Enschede, The Netherlands. 4. 4 Medisch Spectrum Twente, Medical School Twente, Enschede, The Netherlands. 5. 5 Department of Research Methodology, Measurement and Data Analysis, University of Twente, Enschede, The Netherlands. 6. 6 Department of Amputation and Orthopaedics, Roessingh Centre for Rehabilitation, Enschede, The Netherlands.
Abstract
OBJECTIVE: (1) To study the effects of providing ankle-foot orthoses in subjects with (sub)acute stroke; and (2) to study whether the point in time at which an ankle-foot orthosis is provided post-stroke (early or delayed) influences these effects. DESIGN: Randomized controlled trial. SETTING: Rehabilitation centre. SUBJECTS:Unilateral hemiparetic stroke subjects with indication for use of an ankle-foot orthosis and maximal six weeks post-stroke. INTERVENTIONS: Subjects were randomly assigned to: early provision (at inclusion; Week 1) or delayed provision (eight weeks later; Week 9). OUTCOME MEASURES: 10-metre walk test, 6-minute walk test, Timed Up and Go Test, stairs test, Functional Ambulation Categories, Berg Balance Scale, Rivermead Mobility Index and Barthel Index; assessed in Weeks 1, 3, 9 and 11. RESULTS: A total of 33 subjects were randomized (16 early, 17 delayed). Positive effects of ankle-foot orthoses were found two weeks after provision, both when provided early (significant effects on all outcomes) or delayed (Berg Balance Scale p = 0.011, Functional Ambulation Categories p = 0.008, 6-minute walk test p = 0.005, Timed Up and Go Test p = 0.028). Comparing effects after early and delayed provision showed that early provision resulted in increased levels of improvement on Berg Balance Scale (+5.1 points, p = 0.002), Barthel Index (+1.9 points, p = 0.002) and non-significant improvements on 10-metre walk test (+0.14 m/s, p = 0.093) and Timed Up and Go Test (-5.4 seconds, p = 0.087), compared with delayed provision. CONCLUSIONS: We found positive effects of providing ankle-foot orthoses in (sub)acute stroke subjects that had not used these orthoses before.
RCT Entities:
OBJECTIVE: (1) To study the effects of providing ankle-foot orthoses in subjects with (sub)acute stroke; and (2) to study whether the point in time at which an ankle-foot orthosis is provided post-stroke (early or delayed) influences these effects. DESIGN: Randomized controlled trial. SETTING: Rehabilitation centre. SUBJECTS: Unilateral hemiparetic stroke subjects with indication for use of an ankle-foot orthosis and maximal six weeks post-stroke. INTERVENTIONS: Subjects were randomly assigned to: early provision (at inclusion; Week 1) or delayed provision (eight weeks later; Week 9). OUTCOME MEASURES: 10-metre walk test, 6-minute walk test, Timed Up and Go Test, stairs test, Functional Ambulation Categories, Berg Balance Scale, Rivermead Mobility Index and Barthel Index; assessed in Weeks 1, 3, 9 and 11. RESULTS: A total of 33 subjects were randomized (16 early, 17 delayed). Positive effects of ankle-foot orthoses were found two weeks after provision, both when provided early (significant effects on all outcomes) or delayed (Berg Balance Scale p = 0.011, Functional Ambulation Categories p = 0.008, 6-minute walk test p = 0.005, Timed Up and Go Test p = 0.028). Comparing effects after early and delayed provision showed that early provision resulted in increased levels of improvement on Berg Balance Scale (+5.1 points, p = 0.002), Barthel Index (+1.9 points, p = 0.002) and non-significant improvements on 10-metre walk test (+0.14 m/s, p = 0.093) and Timed Up and Go Test (-5.4 seconds, p = 0.087), compared with delayed provision. CONCLUSIONS: We found positive effects of providing ankle-foot orthoses in (sub)acute stroke subjects that had not used these orthoses before.
Authors: Corien D M Nikamp; Marte S H Hobbelink; Job van der Palen; Hermie J Hermens; Johan S Rietman; Jaap H Buurke Journal: PLoS One Date: 2019-03-12 Impact factor: 3.240