Using double blind, randomized controlled design to investigate the short-term therapeutic effects of function of customized insoles on children with developmental delays
A total of 52 children with developmental delays will be enrolled. The participants will be randomized into two groups, including study group (with insoles) and control group (without insoles). The participants in the study group will be evaluated at baseline, that is before the customized insoles are prescribed. All of evaluations, including physical function, balance, and quality of life will be re-evaluated up to 12 weeks after insoles wearing. The control group will be evaluated at the baseline and up to 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
52
insoles
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan
change from baseline functional performance (scores) at 12 weeks
Pediatric Outcome Data Collection Instrument
Time frame: baseline and up to 12 weeks
change from baseline physical function (time) at 12 weeks
time of stair climbing, timed up and go, walking on level ground
Time frame: baseline and up to 12 weeks
change from baseline balance (scores) at 12 weeks
Berg balance scale
Time frame: baseline and up to 12 weeks
change from baseline quality of life at 12 weeks
Pediatric Quality of Life inventory (PedsQL)
Time frame: baseline and up to 12 weeks
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