Gait in Children With Down Syndrome While Wearing Orthoses

NCT01598350 | Completed Results

• 1 other identifier: 0910-003
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

On average, Down syndrome (DS) occurs once in every 700 live births and results in life-long disability and increased risk for comorbidities.1 Individuals with DS are also susceptible to secondary physical impairments and limitations as a result of complications associated with joint hypermobility, hypotonicity, and increased ligamentous laxity. Secondary impairments such as pes planus (flat feet), weakened muscles, bony abnormalities and arthritis may lead to painful joints and feet. Additionally, children with DS often manifest deviations in gait as a result of physical limitations imposed by orthopedic and muscular deficiencies that may lead to decreased postural stability. These secondary losses in function, which exacerbate disabilities, may be preventable with the use of appropriate early interventions aimed at correcting abnormal joint alignment. Research exploring effective physical therapy interventions for adults and children with DS is currently very limited. However, the use of orthotic devices to support lax ligaments and hypotonic muscles, which are common manifestations of DS, is one accepted method of intervention for children within this population. Orthoses are variable in structure and the degree of support provided to the foot and ankle also differ between foot orthoses (FOs) and supramalleolar orthoses (SMOs). Previous studies have supported the effectiveness of orthoses on improving ankle and foot alignment, as well as gait parameters. However, disagreement currently exists concerning which type of orthotic device is most beneficial for the population of children with DS. Children with DS express variable degrees of joint laxity and hypotonicity, as well as differences in the severity of specific alignment abnormalities such as excessive pronation or calcaneal eversion.6 Current literature is insufficient for explaining differences in the benefits provided by FOs and SMOs and the specific indications for their use in children with DS is unclear. Study Aims This study will demonstrate the differences in structural outcomes provided by FOs and SMOs and develop specific criterion for matching individuals of differing orthopedic impairments with the most beneficial orthotic device.

Conditions

Down Syndrome

Keywords

Gait; Orthoses; Down syndrome

Outcome Measures

Primary Outcomes (1)

• Step Width

  60 minutes

Study Arms (1)

Orthotic

EXPERIMENTAL

Orthotic Use

Device: Supramalleolar Orthoses (Cascade)

Interventions

Supramalleolar Orthoses (Cascade) DEVICE

Walk wearing supramalleolar orthoses - three trial

Also known as: Cascade - leap frog

Orthotic

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Participants must be able to walk independently or with an assistive device, for 50 feet at one time, and have at least six months of walking experience. Participants must also be able to follow simple verbal instructions.

Sponsors & Collaborators

• University of Puget Sound: lead

Study Sites (1)

University of Puget Sound

Tacoma, Washington, 98406, United States

Location

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Limitations and Caveats

small number of subject recruited.

Results Point of Contact

• Title: Julia Looper, PT PhD
• Organization: University of Puget Sound

jlooper@pugetsound.edu

253 879 2895

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 20, 2010
• First Posted: May 15, 2012
• Study Start: January 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 30, 2013
• Results First Posted: December 30, 2013

Record last verified: 2013-11

Locations

US (1)