Comparison of the Effect of Supportive Ankle Orthoses and Balance Training on Gait Initiation and postural control in Individuals with Chronic Ankle Instability

To investigate the effect of supportive ankle orthosis and balance training on gait initiation and postural control in individuals with chronic ankle instability

Parallel group, Randomized controlled trial with outcome assessor blinded

All the assessments, interventions, and data collection steps will be carried out at the School of Rehabilitation Sciences, Iran University of Medical Sciences

criteria are in-line with the recommendations made by the International Ankle Consortium. Age range 18 to 40 years old. a history of at least 1 ankle sprain which had limited patients activity at that day and had been associated with inflammatory signs. self-reported history of the first ankle sprain more than 12 months ago. The last sprain has occurred at least 3 month ago. history of at least two episodes of ‘giving way’ and ‘feelings of ankle joint instability’ during the last 6 months. Cumberland Ankle Instability Tool (CAIT) score ≤ 24. Having self-assessed disability scores of ≤90% on the activities of daily living subscale of Foot and Ankle Ability Measure (FAAM); and having self-assessed disability scores ≤80% on the sports subscale of Foot and Ankle Ability Measure (FAAM).

Four Groups: Semi-rigid ankle orthosis, balance training, combine two intervention (e.g. semi-rigid orthosis + balance training), control group

Primary outcome: Star Excursion Balance teat. Secondary outcomes: parameters extracted of Gait initiations, time to boundary, kinesiophobia, self reported ankle instability, self reported foot and ankle ability measure

The group allocation will be performed through permuted block randomization at an assignment ratio of 1:1:1:1. For allocation concealment, the randomization codes will be kept in opaque, sealed, sequentially numbered envelopes. Sample size is estimated at 52, however, to take account of potential withdrawals, 64 patients (n=16 per group) will be recruited for the study. First, create and seal 16 treatment A envelopes, 16 treatment B envelopes, 16 treatment C envelopes, and 16 treatment D envelopes. To create a block of 8, we will select 2 treatment A envelopes, 2 treatment B envelopes, 2 treatment C envelopes, and 2 treatment D envelopes. We will shuffle these 8 envelopes thoroughly, and place this block of 8 in a separate pile. Then, we will prepare additional blocks of 8 until all 16 treatment A, B, and C envelopes have been used. All additional blocks will be placed in their own individual piles. We will have 8 individuals piles of shuffled blocks of 8.

The outcome assessor will be blinded to group allocation, because all dependent variables will be measured without the orthosis, and the patients will remove their orthosis before referring for post-intervention assessment. Furthermore, all data will be encoded to prevent bias and to blind the statistician.

Our research findings will be shared with all researchers, and practitioners. We will publish our research findings in scientific journals

All documents can be shared 1 year after article publication

Researchers and health practitioners

Use of data is only possible by mentioning the name and organizational affiliation of the correspond and co-author of the project and the published article.

Fatemeh Azadinia

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