title: A pilot study of a crossover trial with randomized use of ankle-foot orthoses for people with Charcot-Marie-tooth disease.
abstract: OBJECTIVE
  This was a pilot and feasibility study of a crossover trial with randomized use of ankle-foot orthoses by people with Charcot-Marie-tooth (CMT) disease, investigating the effects of these on gait parameters, practical aspects of use and achievement of goals.
  
  
  METHODS
  A randomized crossover trial.
  
  
  METHODS
  The community and ambulatory care.
  
  
  METHODS
  Eight adults with CMT disease type 1 or 2.
  
  
  METHODS
  Ligaflex™, custom-made polypropylene and silicone ankle-foot orthoses worn in randomized order for three weeks each, with a washout week in-between; the orthoses of each participant's choice were then worn until 28 weeks.
  
  
  METHODS
  The primary outcome measure was gait velocity; other outcome measures included Goal Attainment Scaling; Likert scores, concerning aspects of orthosis use and gait analysis parameters.
  
  
  RESULTS
  Gait velocity was greatest wearing polypropylene orthoses, median 0.96 (interquartile range (IQR) 0.75-1.18) ms(-1), compared with silicone orthoses, median 0.88 (0.71-1.12) ms(-1), and no orthosis, median 0.79 (0.56-0.84) ms(-1), P=0.006. The silicone orthoses met goals more successfully and scored more favourably for comfort, 5.0 (5.0-6.0), P=0.003 and pain, 5.5 (4.0-7.0), P=0.015. Future modifications to study methodology were identified, such as a longer period of wear and measurement of walking in different situations.
  
  
  CONCLUSIONS
  This study confirmed the feasibility of a larger trial. It indicated differences in walking velocity and parameters concerning wear of the orthoses that could be explored further. A further crossover trial would require 27 participants in order to show a clinically meaningful difference in velocity of 0.13 ms(-1) with 90% power and alpha of 5%.
authors.affiliation: University of Nottingham, Division of Rehabilitation Medicine, Derby City Hospital, Derby, UK. margaret.phillips@nottingham.ac.uk
authors.forename: Margaret F
authors.initials: MF
authors.lastname: Phillips
authors.forename: Zoe
authors.initials: Z
authors.lastname: Robertson
authors.forename: Brian
authors.initials: B
authors.lastname: Killen
authors.forename: Barney
authors.initials: B
authors.lastname: White
mesh_terms: D000368:Aged; D000842:Ankle; D001915:Braces; D002607:Charcot-Marie-Tooth Disease / Q000534:rehabilitation*; D018592:Cross-Over Studies; D005240:Feasibility Studies; D005528:Foot; D020233:Gait Disorders, Neurologic / Q000534:rehabilitation; D006801:Humans; D008875:Middle Aged; D010147:Pain Measurement; D017060:Patient Satisfaction; D010865:Pilot Projects; D011126:Polypropylenes; D012828:Silicones
chemical_list: D011126:Polypropylenes; D012828:Silicones