Independent Walking Speed and Crossing a City Street

Sponsor
Blythedale Children's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02842398
Collaborator
(none)
71
1
2
62
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Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Balance Master
  • Behavioral: Customary Care
Early Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
71 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Nov 1, 2010
Actual Primary Completion Date :
Jan 1, 2016
Actual Study Completion Date :
Jan 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in gait velocity after intervention [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 Outcome Measures

  1. Weight [Day 1 of Intervention]

    Body weight on a digital scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 21 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Blythedale Children's Hospital Valhalla New York United States 10595

Sponsors and Collaborators

  • Blythedale Children's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Blythedale Children's Hospital
ClinicalTrials.gov Identifier:
NCT02842398
Other Study ID Numbers:
  • Balance_Master
First Posted:
Jul 22, 2016
Last Update Posted:
May 18, 2018
Last Verified:
May 1, 2018
Keywords provided by Blythedale Children's Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 18, 2018