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The Effect of Insoles on Functional Performance in Pediatric Flexible Flatfoot

The Effect of Insoles on Functional Performance in Pediatric Flexible Flatfoot

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05533762
Enrollment
30
Registered
2022-09-09
Start date
2022-09-15
Completion date
2023-12-31
Last updated
2022-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Flatfoot, Flexible

Brief summary

Flexible flatfoot is a condition that increase the load of the foot structure.With prolonged standing or walking, some children with flatfoot experience rapid discomfort or fatigue in the foot In this study, the investigators investigated the short-term effects of customized insoles on body functions and structures, and activities and participation in children with flexible flatfoot.

Detailed description

Flexible flatfoot is a condition that involves the collapse of the medial longitudinal arch of the foot during weight-bearing stress and the restoration of the arch after the removal of body weight. Flatfoot may increase the load of the foot structure, potentially interfering with normal foot function. With prolonged standing or walking, some children with flatfoot experience rapid discomfort or fatigue in the foot, pain in the plantar foot, and instability of the medial foot structure. Treatment effect of corrective shoes or insoles on flexible flatfoot in children remain uncertain. In this study, the investigators investigated the short-term effects of customized insoles on body functions and structures, and activities and participation in children with flexible flatfoot. The investigators hypothesized that the short-term use of customized insoles improves the scores for measures of body functions and structures and activities and participation. The investigators hypothesized that the short-term use of customized insoles improves the scores for measures of body functions and structures and activities and participation.

Interventions

DEVICEarch insole and sham insole

children wear insoles on feet

Sponsors

Taipei Medical University WanFang Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
3 Years to 10 Years
Healthy volunteers
Yes

Inclusion criteria

* Children presenting symptomatic flexible flatfoot only

Exclusion criteria

* Children with a history of foot injury or surgery, foot abnormalities or a confirmed diagnosis such as neurological deficits.

Design outcomes

Primary

MeasureTime frameDescription
Change in Functional Reach Test(FRT) from pre to post-intervention.up to 10 minutesThe Functional Reach Test (FRT) is a quick screen for determining balance capacity.
Pediatric Berg Balance Scaleup to 30 minutesPediatric Berg Balance Scale was developed to measure balance among older people with impairment in balance function by assessing the performance of functional tasks. Maximum score is 56 ,and minimum values is 0. Score 54-56 means a better outcome.

Secondary

MeasureTime frameDescription
Change in Center of pressure (CoP) from pre to post-intervention.up to 30 minutesThe center of pressure (CoP) measures derived from the foot pressure mat and force plate of RSSCAN system.

Contacts

Primary ContactYenTing LIU
95175@w.tmu.edu.tw+886-229307930

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026