Background
Inclusion criteria | Exclusion criteria |
---|---|
Age: 18 to 40 years | Pregnancy |
Acute, unilateral, unstable, inversion ankle sprain (Grade II, III) | Conditions affecting the neuromuscular or musculoskeletal system |
Signed informed consent | Previous surgical interventions to the foot, ankle, knee or hip; known FAI, CAI |
Patient can read and understand German | Conditions possibly affecting balance |
Cardiovascular disease including thrombosis | |
Respiratory diseases | |
Abdominal diseases (including gallstones) | |
Urological diseases (including kidney and bladder stones) | |
Gynaecological diseases and + intrauterine devices | |
Neurological diseases including epilepsy within the last 2 years | |
Acute injuries to the head | |
Patient is not available for follow-up visits | |
Patient unable to give informed consent | |
Patient suspected to be non-compliant |
Aim of study
Hypotheses
Methods/Design
Study design and protocol
Study centers, population, screening and randomization
Intervention
Lvl | Phases | Time | Symptoms | Treatment Goals | Physiotherapy: | Physiotherapy: |
---|---|---|---|---|---|---|
CONTROL GROUP | INTERVENTION GROUP1
| |||||
1 | Inflam. | 0 - 3d | ▪ Pain at rest | ▪ Reduction of pain and swelling | ▪ PRICE | |
▪ Swelling and hematoma | ▪ Improvement of perfusion | ▪ NSARDs | ||||
▪ Pain during weight bearing | ▪ Partial weight bearing | ▪ Pain-dependent weight bearing +/- crutches | ||||
▪ Pain-dependent mobilization of the foot | ||||||
▪ No tape or brace (due to swelling) | ||||||
2 | Prolif. | 4 - 10d | ▪ Foot can actively be put into neutral position | ▪ Restoring function | ▪ NSARDs | Frequency 10Hz / 16 Hz |
▪ Reduction of swelling | ▪ Restoring full weight bearing | ▪ Pain-dependent weight bearing +/- crutches | Amplitude: s. below | |||
▪ Partial weight bearing without complete heel-to-toe movement | ▪ Arch of foot / leg axis | Duration: 5min | ||||
▪ Possible fear of movement | ▪ Training of symmetrical gait and regular foot strike | Exercises, vibration: | ||||
▪ Exercises to improve ROM, active stabilization, coordination and regular walking pattern | ▪ Gymnastic ball, feet parallel to mark 1 or 2, patient rolls forth and back, in order to Flex/Ext. in the upper ankle joint | |||||
▪ Brace | ▪ Gymnastic ball, injured foot placed transverse on the WBV platform (ankle in-between mark 0 and 1), patient rolls forth and back, in order to flex/extent in the upper ankle joint | |||||
Exercises, general: | ||||||
▪ Pain dependent weight bearing +/- Crutches | ||||||
▪ Walking motion training | ||||||
3 | Early Remod. | 11 - 21d | ▪ Residual hematoma | ▪ Improving muscular strength, and active/ functional ankle stability, and ROM | ▪ Information on preventive measures (Brace) | Frequency: >10Hz, 18-24Hz |
▪ Normal heal-to-toe movement | ▪ Training regular walking pattern and climbing stairs | ▪ Exercises to improve balance, ROM, muscle strength, walking pattern, running and climbing the stairs | Amplitude: 1-2,5mm | |||
▪ Pain and fear of movement under load | ▪ Dynamic stability: stepwise increase of training intensity; switching from static to dynamic exercises | Duration: 3 Sets a 3 Min with 2 Min break each | ||||
▪ Guidance for home training | Exercises, vibration: | |||||
1) Dynamic squatting (warm-up) | ||||||
2) Dynamic squatting (increasing depth) | ||||||
3) Two leg stance with slightly bend knees, slow weight transfer (right ←→ left) | ||||||
4) One-leg squatting, transverse to WBV plate +/- support of the non-injured leg | ||||||
Exercises, general: | ||||||
▪ Guidance for home training | ||||||
4 | Late Remod. | 3 - 6wk | ▪ No hematoma | ▪ Improvement of resistance during walking, running, climbing stairs | ▪ Exercises to improve coordination (skipping, jumping, …) | Frequency: >10Hz, 18-24Hz |
▪ Dorsal flexion possible | ▪ Improvement of work/sports specific tasks | ▪ Stepwise load increase and switching from static to dynamic / from simple to complex / from cyclic to non-cyclic exercises | Amplitude: 2-3mm | |||
▪ No more pain or fear of movement during sports | ▪ Guidance for home training | Duration: 3 Sets a 3 Min with 2 Min break each | ||||
Exercises, vibration: | ||||||
1) Dynamic squatting (warm-up) | ||||||
2) Side-skipping with flexed knees | ||||||
3) Calf raises | ||||||
4) Vibration on a tilted surface, elevated leg = uninjured leg | ||||||
5) Static squats (45° / 90°); Frequency 18+, Amplitude 2+ | ||||||
Exercises, general: | ||||||
▪ Guidance for home training |
Outcome parameters
Primary Outcome parameter (1)
| |
(short term; 6 weeks) | |
Postural control: Balance Test (Sway Index)* | [numeric, scale] |
Primary Outcome parameter (2)
| |
(mid-term; 1 year) | |
Subjective Instability (Giving-way) | [dichotomous variable] |
Secondary Outcome parameters
| |
Return to pre-injury level of activity (work, sports) | [dichotomous variable] |
Residual pain: | |
Pain at rest | [dichotomous variable; VAS] |
Pain on weight-bearing | [dichotomous variable; VAS] |
Pain during sports | [dichotomous variable; VAS] |
Subjective Instability (Giving-way) | [dichotomous variable] |
Recurrence | [dichotomous variable] |
Objective instability: | |
Anterior drawer | [dichotomous variable] |
Talar tilt | [dichotomous variable] |
Ankle ROM | [numeric, scale] |
Postural control: Balance Test (Sway index)* | [numeric, scale] |
Energy/coordination: | |
Multiple one leg hopping* | [numeric, scale] |
Single two leg jump* | [numeric, scale] |
Complications | [text] |
Scores: | |
Foot and Ankle Disability Index[60] | [numeric, scale] |
EQ 5D 5L | [numeric, scale] |