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. 2019 Oct 6;2019(10):CD012363. doi: 10.1002/14651858.CD012363.pub2

RBR‐7QNFFG.

Trial name or title The effects of muscle strengthening of the plantar flexors on the gait pattern of children with idiopathic toe walking.
Methods Randomized, blinded, controlled, two‐arm parallel‐group trial
Participants Planned 30 participants with idiopathic toe walking, 5 years to 11 years old
Exclusions: "structural ankle deformity in equine (inability to reach the ankle neutral position passively); with central or peripheral neurological impairment; who are unable to minimally understand the questions used during the evaluations; which have undergone surgery in the lower limbs or who have undergone the application of botulinum toxin in the last 12 months"
Interventions Intervention group: same protocol of conservative treatment, with the addition of the triceps sural muscle strengthening exercise. The protocol will also have a total duration of 8 weeks and will be applied twice a week. The duration of a single session will be approximately 1 hour and 15 minutes (N = 15 (planned))
Control group: conservative treatment (stretching exercises of the triceps muscle, muscle strengthening of the anterior tibial, sensory‐motor and gait phases training). Duration 8 weeks, applied twice a week. The duration of a single session will be approximately 1 hour (N = 15 (planned))
Outcomes Primary outcome
Active range of motion of ankle dorsiflexion, assessed by a two‐dimensional kinematic analysis of the sagittal plane. The kinematic evaluation will be performed using a video recording in the sagittal plane of the lower limbs. The most affected side (with a lower amplitude of dorsiflexion) will be used to compare the groups.
Two‐dimensional kinematics will be performed at baseline and at the end of treatment (8 weeks).
"A mean difference of 6.29 degrees of the amplitude of ankle dorsiflexion will be taken as the basis for establishing clinical significance. Such a difference is expected between the beginning and the end of the treatment and between groups, to affirm that the intervention group was superior to the control group."
Secondary outcomes
Static and dynamic balance, measured by the KTK test (baseline and at the end of treatment (8 weeks))
Passive range of motion, measured by the lunge‐test (baseline and at the end of treatment (8 weeks))
Ped4.0 quality of life questionnaire (baseline, at the end of treatment (8 weeks) and 24 weeks after the baseline (follow‐up))
Starting date Date of first enrolment: 2 February 2018
Contact information Vanessa Gonçalves Coutinho de Oliveira
vanessagcoliveira@gmail.com
Universidade Federal de São Paulo, Brazil
Notes Primary sponsor: Universidade Federal de São Paulo
Secondary sponsor: Instituto de Assistência ao Servidor Público Estadual de São Paulo
UTN number: U1111‐1200‐9696