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).

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy; Balance Problems
• Intervention / Treatment: Behavioral: Balance Master; Behavioral: Customary Care

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Valhalla, New York, United States, 10595
      • Blythedale Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 21 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Balance Master Training; Children receive one weekly Balance Master training session, in addition to their weekly physical therapy sessions. During Balance Master training, children practice balance on a Balance Master device that simulates crossing a city street.	Behavioral: Balance Master
ACTIVE_COMPARATOR: Customary Care; Children received their customary scheduled physical therapy sessions, without Balance Master training	Behavioral: Customary Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in gait velocity after intervention	Measure gait velocity as participant walks across a force plate on the floor	measured at day 1 of intervention and end of week 6 of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Body weight on a digital scale	Day 1 of Intervention

Collaborators and Investigators

• Sponsor: Blythedale Children's Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (ACTUAL): January 1, 2016
• Study Completion (ACTUAL): January 1, 2016

Study Registration Dates

• First Submitted: July 18, 2016
• First Submitted That Met QC Criteria: July 20, 2016
• First Posted (ESTIMATE): July 22, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 18, 2018
• Last Update Submitted That Met QC Criteria: May 17, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: gait; balance; street-crossing
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: Balance_Master