NCT02193386

Brief Summary

The study aims to evaluate evidence-based practice behavior in usual care physical therapy in Flanders. Secondly, it aims to compare the effectiveness of a predefined physical therapy program based on evidence-based guidelines to the effects of a period of usual care. It is hypothesized that supporting therapists by providing a predefined evidence-based intervention program, will result in an improved treatment outcome compared to the usual care physical therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 17, 2014

Completed
Last Updated

July 17, 2014

Status Verified

September 1, 2010

Enrollment Period

3.5 years

First QC Date

July 10, 2014

Last Update Submit

July 14, 2014

Conditions

Cerebral Palsy

Keywords

Cerebral PalsyPhysical Therapygait analysisgross motor function

Outcome Measures

Primary Outcomes (1)

  • Change in Gross Motor Function Measure - 88

    baseline, after 10 weeks of usual care and after 10 weeks of intervention

Secondary Outcomes (1)

  • Change in three-dimensional gait analysis

    baseline, after 10 weeks of usual care and after 10 weeks intervention

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

No intervention, no follow-up, only registration of usual therapy

Other: No intervention, no follow-up, only registration

Intervention period

EXPERIMENTAL

Predefined, evidence-based program and support

Other: Intervention period

Interventions

No intervention, no follow-up, only registrationOTHER

Usual Care

Usual Care
Intervention periodOTHER

Predefined intervention program

Intervention period

Eligibility Criteria

Age4 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Cerebral Palsy
  • Age 4- 9 y
  • Gross Motor Function Classification I-III (ambulant)

You may not qualify if:

  • Severe associated problems limiting participation to the programs
  • Severe musculoskeletal limitations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Leuven (Pellenberg) - Reference centre for children with Cerebral Palsy

Pellenberg, Flanders, 3212, Belgium

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2014

First Posted

July 17, 2014

Study Start

September 1, 2010

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

July 17, 2014

Record last verified: 2010-09

Locations

BE(1)