NCT02842398

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Nov 2010

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 22, 2016

Completed
Last Updated

May 18, 2018

Status Verified

May 1, 2018

Enrollment Period

5.2 years

First QC Date

July 18, 2016

Last Update Submit

May 17, 2018

Conditions

Balance ProblemsCerebral Palsy

Keywords

gaitbalancestreet-crossing

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Weight

    Day 1 of Intervention

Study Arms (2)

Balance Master Training

EXPERIMENTAL

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

Customary Care

ACTIVE COMPARATOR

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

Behavioral: Customary Care

Interventions

Balance MasterBEHAVIORAL
Balance Master Training
Customary CareBEHAVIORAL
Customary Care

Eligibility Criteria

Age5 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Ability to ambulate independently at least 25 feet with or without assistance device and/or orthoses.
  • Receiving physical therapy services that include ambulation training.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Blythedale Children's Hospital

Valhalla, New York, 10595, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2016

First Posted

July 22, 2016

Study Start

November 1, 2010

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

May 18, 2018

Record last verified: 2018-05

Locations

US(1)