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Effect of the use of Orthoses on walking of children and adolescents with Charcot-Marie-Tooth

Effect of the use of Assistive Technology Devices on the gait of children and adolescents with Charcot-Marie-Tooth: clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6gmrmbm
Enrollment
Unknown
Registered
2023-05-01
Start date
2023-02-27
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Charcot-Marie-Tooth Disease

Interventions

This is a single arm clinical trial, so there will be no control group and randomisation. The group will be composed of a convenience sample of 34 children and adolescents (3-18 years old), diagnosed
muscle strength of the dorsiflexors and/or plantar flexors less than 3 in the manual test. During the six-month intervention period of the study, the participants must use an assistive technology devi
Z46.7

Sponsors

Faculdade de Medicina de Ribeirão Preto Universidade de São Paulo
Lead Sponsor
Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Collaborator

Eligibility

Age
3 Years to 18 Years

Inclusion criteria

Inclusion criteria: Participants aged 3 to 18 years, with a medical diagnosis of CMT any subtype; presenting independent deambulation ability; clinical impairment of the distal lower limbs with postural alterations in the feet, identified by the Foot Postural Index or plantar pressure analysis, muscular strength of the dorsiflexors and/or plantar flexors less than 3 in the manual test; and who accept and sign, together with their legal guardians, the Terms of Consent and Informed Consent.

Exclusion criteria

Exclusion criteria: Participants diagnosed with diabetic polyneuropathy; those with a history of surgery or trauma to the lower limbs in the six months prior to the evaluation; and those who do not understand the commands offered by the evaluator.

Design outcomes

Primary

MeasureTime frame
It is expected to find a reduction of the pressure peak in the plantar region of the foot, verified through the analysis of the plantar pressure, after a period of six months of use of the assistive technology device.—

Secondary

MeasureTime frame
It is expected to find a better performance of balance, verified by a higher score in the Bruininks-Oseretsky test and an improvement in the walking ability, verified by the total distance walked in the 6-minute walk test, after the period of six months of use of the assistive technology device.—

Countries

Brazil

Contacts

Public ContactJuliana Cardoso

Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

cardosojulianafisio@gmail.com+55-016-33150739

Outcome results

None listed

Source: REBEC (via WHO ICTRP)