Clinical trial NCT02842398: Independent Walking Speed and Crossing a City Street
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Balance Problems
Cerebral Palsy
Keywords: gait
balance
street-crossing
Lead sponsor: Blythedale Children's Hospital
Sponsor class: OTHER
First posted: 2016-07-22
Enrollment: 71
Sex: ALL
Minimum age (years): 5
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in gait velocity after intervention
timeFrame: measured at day 1 of intervention and end of week 6 of intervention
Secondary outcomes:
measure: Weight
timeFrame: Day 1 of Intervention
Other outcomes:
Locations:
city: Valhalla
country: United States
facility: Blythedale Children's Hospital
state: New York
Study officials:
References: