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Trials - SLCTR/2023/016

Protocol Change

Date

2024-12-19


Protocol

Protocol changed


Item Changed

Secondary outcome(s)


Previous Version

1.Pain interference and disability assessed by the VISA-A Questionnaire. https://www.physiotutors.com/questionnaires/visa-a-achilles-questionnaire/ [Baseline, 4 weeks, 8 weeks, 12 weeks, 18 weeks, and 26 weeks ]; 2.Time to return to sport [Calculation of days from date of injury to the date of starting the sport back ]; 3.Achilles tendon capacity measured by Calf raise to Fatigue test, compared against the baseline and the unaffected side at specified time points. [Baseline, 4 weeks, 8 weeks, 12 weeks, 18 weeks, and 26 weeks ]; 4.Achilles tendon flexibility measured by Knee-to-Wall test, compared against the baseline and the unaffected side at specified time points. [Baseline, 4 weeks, 8 weeks, 12 weeks, 18 weeks, and 26 weeks ]; 5.Steady state concentration of the retinyl palmitate level in the blood will be calculated using Vitamin A test [12 weeks and 26 weeks ]


Next Version

a. Pain interference and disability will be assessed by the VISA-A Questionnaire. b. Time to return to sport will be from the time study intervention is first delivered. c. Achilles tendon capacity will be measured by Calf raise to Fatigue, compared against the baseline and the unaffected side at specified time points above. d. Achilles tendon flexibility will be measured by Knee-to-Wall test, compared against the baseline and the unaffected side at specified time points above. e. Steady state concentration of Retinyl Palmitate at 12 weeks and 26 weeks