Cerebral Palsy Clinical Trial
| NCT number | NCT01335100 |
| Other study ID # | BTX-GPS |
| Secondary ID | |
| Status | Active, not recruiting |
| Phase | N/A |
| First received | June 6, 2010 |
| Last updated | May 1, 2011 |
| Start date | March 2010 |
| Verified date | May 2011 |
| Source | Shaare Zedek Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health |
| Study type | Observational |
Background:
Motor impairment limits social and recreational activities in children with cerebral palsy
(CP), compromising participation and impacting on quality of life. Improvement of motor
function by medical treatment may advance in participation of outdoor activities and expand
social and recreational activities. While Botulinum toxin (BTX) injections are effective and
safe treatment for spasticity in children with CP, there is insufficient evidence for
improvement of motor function and enhanced participation in this population.
Objective:
To examine outdoor activity as a functional outcome following lower limb BTX in children
with CP.
Methods:
In this pilot study the investigators will use Global Positioning Systems (GPS) to measure
walking speed, distances, number of walking events and destinations in ambulatory children
with CP following BTX injection to the lower limbs; age and gender matched sibling will be
studied as a control group. Outdoor activity will be measured at 1, 3 and 6 months following
BTX treatment will be compared to baseline and to those of siblings. Outdoor activity will
be correlated with leisure activity preferences and quality of life questionnaires.
Significance: Improvement in outdoor activity following BTX injections in this pilot study
will assist construction of a larger study evaluating participation and quality of life in
children with CP.
| Status | Active, not recruiting |
| Enrollment | 10 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 5 Years to 18 Years |
| Eligibility |
Inclusion Criteria: - ambulatory children with CP following BTX injection to the lower limbs Exclusion Criteria: - significant psychomotor retardation, psychiatric symptoms or behavioral problem that may impact on outdoor activity prefernces |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Israel | Shaare Zedek Medical Center | Jerusalem |
| Lead Sponsor | Collaborator |
|---|---|
| Shaare Zedek Medical Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | outdoor activity | 9 months | No | |
| Secondary | leisure activity preferences and quality of life | 9 months for the pilot | No |
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