A pilot study of a crossover trial with randomized use of ankle-foot orthoses for people with Charcot-Marie-tooth disease

Clin Rehabil. 2012 Jun;26(6):534-44. doi: 10.1177/0269215511426802. Epub 2011 Nov 16.


Objectives: 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.

Design: A randomized crossover trial.

Setting: The community and ambulatory care.

Participants: Eight adults with CMT disease type 1 or 2.

Interventions: 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.

Main outcome measures: 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%.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Ankle
  • Braces*
  • Charcot-Marie-Tooth Disease / rehabilitation*
  • Cross-Over Studies
  • Feasibility Studies
  • Foot
  • Gait Disorders, Neurologic / rehabilitation
  • Humans
  • Middle Aged
  • Pain Measurement
  • Patient Satisfaction
  • Pilot Projects
  • Polypropylenes
  • Silicones


  • Polypropylenes
  • Silicones