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Independent Walking Speed and Crossing a City Street

Primary Purpose

Balance Problems, Cerebral Palsy

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Balance Master
Customary Care
Sponsored by
Blythedale Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Balance Problems focused on measuring gait, balance, street-crossing

Eligibility Criteria

5 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Blythedale Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Balance Master Training

Customary Care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in gait velocity after intervention
Measure gait velocity as participant walks across a force plate on the floor

Secondary Outcome Measures

Weight
Body weight on a digital scale

Full Information

First Posted
July 18, 2016
Last Updated
May 17, 2018
Sponsor
Blythedale Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02842398
Brief Title
Independent Walking Speed and Crossing a City Street
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Blythedale Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Balance Problems, Cerebral Palsy
Keywords
gait, balance, street-crossing

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Balance Master Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Customary Care
Arm Type
Active Comparator
Arm Description
Children received their customary scheduled physical therapy sessions, without Balance Master training
Intervention Type
Behavioral
Intervention Name(s)
Balance Master
Intervention Type
Behavioral
Intervention Name(s)
Customary Care
Primary Outcome Measure Information:
Title
Change in gait velocity after intervention
Description
Measure gait velocity as participant walks across a force plate on the floor
Time Frame
measured at day 1 of intervention and end of week 6 of intervention
Secondary Outcome Measure Information:
Title
Weight
Description
Body weight on a digital scale
Time Frame
Day 1 of Intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Blythedale Children's Hospital
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States

12. IPD Sharing Statement

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Independent Walking Speed and Crossing a City Street

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