Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Independent Walking Speed and Crossing a City Street

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02842398
Recruitment Status : Completed
First Posted : July 22, 2016
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Blythedale Children's Hospital

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
Balance Problems Cerebral Palsy 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2010
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

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



Primary Outcome Measures :
  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 Outcome Measures :
  1. Weight [ Time Frame: Day 1 of Intervention ]
    Body weight on a digital scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842398


Locations
Layout table for location information
United States, New York
Blythedale Children's Hospital
Valhalla, New York, United States, 10595
Sponsors and Collaborators
Blythedale Children's Hospital
Layout table for additonal information
Responsible Party: Blythedale Children's Hospital
ClinicalTrials.gov Identifier: NCT02842398    
Other Study ID Numbers: Balance_Master
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Keywords provided by Blythedale Children's Hospital:
gait
balance
street-crossing
Additional relevant MeSH terms:
Layout table for MeSH terms
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases