The effects of toe spreader in people with overactive toe flexors post stroke: a randomized controlled pilot study

Area of Science:

• Neurorehabilitation
• Biomechanics
• Clinical Trials

Background:

• Chronic stroke often results in gait impairments, including the tonic toe flexion reflex.
• Assistive devices like toe spreaders are explored to mitigate these effects.
• Understanding the efficacy of toe spreaders is crucial for improving patient outcomes.

Purpose of the Study:

• To evaluate the long-term impact of a toe spreader on gait, pain, activity, and balance in chronic stroke survivors with tonic toe flexion reflex.
• To determine optimal sample size for future trials.
• To assess user compliance with the toe spreader.

Main Methods:

• A single-blind, randomized controlled pilot trial was conducted with nine ambulatory participants.
• Participants were assigned to either a control or a customized toe spreader group for six months.
• Gait speed, plantar contact area, pain (VAS), balance (Berg Balance Scale), spasticity (Modified Ashworth Scale), and activity levels were measured.

Main Results:

• No significant differences were observed between the toe spreader and control groups in any measured outcomes.
• Both groups showed non-significant improvements in gait speed, activity level, and stride length.
• Intervention group compliance was suboptimal, with less than 50% usage.

Conclusions:

• The toe spreader did not yield significant improvements in gait, pain, activity, or balance for this patient group.
• Future studies require a minimum sample size of 56 participants.
• Strategies to enhance compliance are essential for future research and potential clinical application.