Independent Walking Speed and Crossing a City Street

Cerebral Palsy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02842398
• Other study ID #: Balance_Master
• Status: Completed
• Phase: Early Phase 1
• Start date: November 2010
• Est. completion date: January 2016

Study information

• Verified date: May 2018
• Source: Blythedale Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Balance Problems
• Cerebral Palsy

Intervention

Behavioral:
• Balance Master

• Customary Care

Locations

Country	Name	City	State
United States	Blythedale Children's Hospital	Valhalla	New York

Sponsors (1)

Lead Sponsor	Collaborator
Blythedale Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Weight	Body weight on a digital scale	Day 1 of Intervention