Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02391324 : Effectiveness of Robotic Gait Training and Physical Therapy for Children and Youth With Cerebral Palsy
PhasePhase 4
AgesMin: 5 Years Max: 18 Years
Eligibility
Inclusion Criteria:

- Diagnosis of CP (any type), GMFCS Levels II and III

- Able to follow GMFM testing instructions, and to participate in a minimum of 30
minutes of active PT (as judged by the child's PT or physician if not followed by a
PT)

- Able to reliably signal pain, fear and discomfort using verbal or nonverbal signals

- Passive range of motion (ROM) of hips and knees within minimum range requirement for
LOK (hip and knee flexion contracture < 10 degrees, and knee valgus < 40 degrees).

- Parent/child agrees to attend 16 study intervention sessions (given within two
10-week periods), a LOK fitting/acclimatization session or fPT acclimatization
session and the three assessment sessions during the course of the study.

- Parent agrees to contact of their primary PT (if not already involved by parent in
the screening process) and their paediatrician or physiatrist to confirm eligibility.

- Parent agrees that regular PT (and other gross motor mobility therapies such as
conductive education and MEDEK) will be discontinued from the time of the baseline
assessment through the 8 to 10 weeks of the active intervention or control group.
Note that home programs such as stretching and strengthening and treadmill and
exercise bike riding (no more than 10 minutes total per day) will be permitted in all
groups.

Exclusion Criteria:

- Botulinum Toxin injection within the past 4 months or planned within the next 6
months

- Fixed knee contracture > 10 degrees, knee valgus >40 degrees such that orthosis will
not be adaptable to lower limbs.

- Hip instability/subluxation as demonstrated by a migration percentage > 45%

- Orthopaedic surgery (soft tissue releases) within the last 9 months, or lower limb
bony surgery within the last 18 months

- Severe spasticity may be a contraindication as determined in Lokomat trial session
using L-FORCE assessment.

- Any weightbearing restrictions.

- Seizure disorder unless fully controlled by medication and no evidence of seizure in
the last 12 months and physician provides singed approval to enter the study

- Open skin lesions or vascular disorder of lower extremities

- Not able to co-operate or be positioned adequately within the LOK as shown during the
fitting/acclimatisation session. -
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02391324      |      Link to official Clinicaltrials.gov listing
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