Independent Walking Speed and Crossing a City Street

NCT ID: NCT02842398

Last Updated: 2018-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2016-01-31

Brief 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).

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.

Conditions

Balance Problems; Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Balance Master

Intervention Type: BEHAVIORAL

Customary Care

Children received their customary scheduled physical therapy sessions, without Balance Master training

Group Type: ACTIVE_COMPARATOR

Customary Care

Intervention Type: BEHAVIORAL

Interventions

Balance Master

Intervention Type: BEHAVIORAL

Customary Care

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Blythedale Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Blythedale Children's Hospital

Valhalla, New York, United States

Countries

United States

Other Identifiers

Balance_Master

Identifier Type: -

Identifier Source: org_study_id