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Completed

NCT Number: NCT02842398

Independent Walking Speed and Crossing a City Street

The purpose of this study is to determine if selected sequence training using the Balance Master, added to established physical therapy treatment programs, will increase gait velocity of ambulatory children receiving inpatient or outpatient rehabilitation in relation to their ability to cross an intersection within the confines of community traffic signal (>120 cm/sec).

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Key information

Age range

5 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Blythedale Children's Hospital

Valhalla, New York, 10595, United States

About this study

The ability to adequately perform functional tasks at a level that allows independent community living is key to measuring the success of any physical therapy program. The essential tasks needed to allow independent community living have been well documented in the elderly population. However, these tasks have not been delineated in the pediatric population. The investigators aim to determine if selected sequence training using the Balance Master, added to established physical therapy treatment programs, will increase gait velocity of ambulatory children receiving in-or outpatient rehabilitation in relation to their ability to cross an intersection within the confines of community traffic signal (>120 cm/sec). One essential task that is necessary in the urban environment is to have the ability to cross a street within the time constraint of a traffic signal. Walking speed becomes increasingly important for those living in urban settings, as the ability to cross the street safely is fundamental for achieving independence. One of the major criticisms of clinic/lab-based measures of gait speed is that relative performance may not be representative of independence within the community. Participants aged 5 to 21 years, will be recruited from the patient population at Blythedale Children's Hospital for a six week trial. Children will be assigned to one of two random groups: one weekly Balance Master sequence training group (in addition to their regularly scheduled therapy sessions) and a group that continue regularly scheduled therapy sessions alone. Gait velocity will be measured by "Walk Across" Functional Assessment using Balance Master long force plate.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to ambulate independently at least 25 feet with or without assistance device and/or orthoses.
  • Receiving physical therapy services that include ambulation training.

Exclusion criteria

  • Diagnosis of a progressive disorder.
  • Inability to follow directions.
  • Uncorrected vision impairment.
  • Require additional physical assistance to ascend a ramp and over force plate.
  • Refusal to participate.

Treatment and study plan

Balance Master

Behavioral

Customary Care

Behavioral

Primary outcomes

  1. Change in gait velocity after intervention

    Time frame: measured at day 1 of intervention and end of week 6 of intervention

    Measure gait velocity as participant walks across a force plate on the floor

Secondary outcomes

  1. Weight

    Time frame: Day 1 of Intervention

    Body weight on a digital scale

Sponsors and collaborators

Lead sponsor

Blythedale Children's Hospital

Other

Registry information

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Jul 22, 2016
Registry last updated
May 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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