Objectives: To investigate the long-term effects of the toe spreader on gait characteristics, pain, activity level and balance in individuals with chronic stroke who exhibited tonic toe flexion reflex. The secondary objectives were to determine the sample size for future studies and to assess compliance to the use of the toe spreader.
Design: Single-blind, randomized controlled pilot trial.
Setting: Outpatient clinic of a tertiary hospital in Singapore.
Subjects: Nine ambulatory participants with tonic toe flexion reflex more than six months post stroke.
Intervention: Control or customized toe spreader groups for six months. The toe spreader was made of Rolyan Ezemix elastomer putty and worn with sport sandals during ambulation.
Main measures: Gait speed and plantar surface contact area, pain visual analogue scale (VAS), Berg Balance Scale, Modified Ashworth Scale, activity level measured on pedometer and compliance via logbook.
Results: There were no significant differences between the groups. Both groups showed non-significant improvements in gait speed (toe spreader 0.34 (0.26) versus 0.37 (0.29) m/s; control 0.40 (0.27) versus 0.50 (0.17) m/s), activity level, step length of the hemiplegic leg and stride length at six months. All participants in the intervention group used the toe spreader less than 50% of the days, indicating suboptimal compliance.
Conclusion: The use of the toe spreader did not result in significant improvements in any outcomes. Studies with sample sizes of at least 56 participants and strategies to increase compliance to the use of the toe spreader are recommended.