NCT00306761

Brief Summary

Cerebral palsy (CP) is a non-degenerative neuromuscular disease that can exist at or occur as a result of birth. Because of damage to one or more parts of the brain that control movement, an affected child cannot control his or her muscles normally. Prevalence of CP is similar worldwide, with pronounced severity in underdeveloped countries due to poor health and financial conditions. Research should be conducted to find methods of medical treatment to allow affected children to maintain or regain musculoskeletal functionality. Many children affected with CP spend much of their days restricted to a rigid wheelchair; limiting muscular and cognitive development, making it difficult to interact with their environment. The gap to be addressed by this study is to determine if a wheelchair that is based on the dynamics of human anatomy can allow enhanced function, while being adaptive to individual growth and development. At present, there is very little dynamic capability available in commercial wheelchairs to allow this mobility. A dynamic wheelchair system was recently designed and a small sample of able-bodied children has been tested in the chair. It is hypothesized that significant increases in functional mobility will be achieved in children with CP from the use of this novel wheelchair design.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2006

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

First Submitted

Initial submission to the registry

March 23, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 24, 2006

Completed
8 days until next milestone

Study Start

First participant enrolled

April 1, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

September 16, 2014

Status Verified

September 1, 2014

Enrollment Period

1.3 years

First QC Date

March 23, 2006

Last Update Submit

September 15, 2014

Conditions

Cerebral Palsy, Spastic

Outcome Measures

Primary Outcomes (3)

  • Joint range of motion

  • Muscle spasticity

  • Functional Capacity Assessments

Interventions

Dynamic Wheelchair Seating SystemDEVICE

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Spastic Cerebral Palsy
  • Requires Wheelchair for mobility

You may not qualify if:

  • Unable to respond to clinical evaluation commands

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Epicenter Therapy Services

Bozeman, Montana, 59715, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Michael E. Hahn, PhD

    Montana State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 23, 2006

First Posted

March 24, 2006

Study Start

April 1, 2006

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

September 16, 2014

Record last verified: 2014-09

Locations

US(1)