NCT02160457

Brief Summary

The aim of this study is to test the hypothesis, that improvements in gait pattern following individually tailored interventions guided by instrumented 3-dimensional gait analysis are superior to those used in 'care as usual'.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration 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

First Submitted

Initial submission to the registry

June 2, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 10, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

August 6, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2017

Completed
Last Updated

April 6, 2018

Status Verified

April 1, 2018

Enrollment Period

2.9 years

First QC Date

June 2, 2014

Last Update Submit

April 4, 2018

Conditions

Cerebral Palsy

Keywords

Cerebral palsyInstrumented gait analysisGait Deviation Index

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Gait Deviation Index

    Gait Deviation Index (GDI) is based upon kinematic data from the Instrumented Gait Analysis, and is an quantitative index that summarises the overall gait pattern into a single score for each patient by comparison with non-pathological gait. A GDI value of 100 represents the absence of gait pathology, and each 10-point decrement below 100 indicates one standard deviation from normal gait kinematics. For the primary outcome measure, the median of five trials for each leg will be used to calculate the average of both legs to provide a single index for each child.

    Baseline, 52 weeks

Secondary Outcomes (7)

  • Change from baseline in 1-minute walk test

    Baseline, 52 weeks

  • Change from baseline in Mobility Scale of the Pediatric Evaluation of Disability Inventory

    Baseline, 52 weeks

  • Change from baseline in Pediatric Quality of Life Inventory Cerebral Palsy Module

    Baseline, 52 weeks

  • Change from baseline in Pediatric Outcome Data Collection Instrument

    Baseline, 52 weeks

  • Change from baseline in Mobility Scale of the Pediatric Evaluation of Disability Inventory

    Baseline, 26 weeks

  • +2 more secondary outcomes

Other Outcomes (4)

  • Change from baseline in Gait Variable Score

    Baseline, 52 weeks

  • Change from baseline in Measure of Processes of Care

    Baseline, 52 weeks

  • Applied interventions

    52 weeks

  • +1 more other outcomes

Study Arms (2)

Intervention with IGA

EXPERIMENTAL

Individually tailored interdisciplinary intervention based on measures performed as part of the Cerebral Palsy follow-Up Program and other clinical examinations AND instrumented gait analysis (IGA)

Other: Intervention with IGA

Intervention without IGA

NO INTERVENTION

'Care as usual' - Individually tailored interdisciplinary interventions based on measures performed as part of the Cerebral Palsy follow-Up Program and other clinical examinations BUT NOT (IGA).

Interventions

Intervention with IGAOTHER

Individually tailored interdisciplinary intervention based on measures performed as part of the Cerebral Palsy follow-Up Program and other clinical examinations AND instrumented gait analysis The instrumented gait analysis consists of four steps: 1. Instrumented gait analysis (data collection with a 8-camera Vicon T40 system (Vicon, Oxford, UK) and 2 force plates (AMTI, OR6-7-1000) 2. Impairment-Focused Interpretation 3. Recommendation for interdisciplinary interventions 4. Dissemination of recommendations The two modalities differs in the use of IGA, but the study is not indented to document the effect of IGA alone, but to document the difference in the effects of the interdisciplinary interventions, when IGA is implemented to the experimental group.

Also known as: Vicon T40 system, Vicon, Oxford, UK, Advanced Mechanical Technology Inc. (AMTI), OR6-7-1000, Watertown, USA
Intervention with IGA

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Spastic Cerebral palsy
  • Gross Motor Function Classification System levels I or II.

You may not qualify if:

  • Earlier interventions in the form of orthopaedic surgery within the past 52 weeks, injection with botulinum toxin type A in the 12 weeks prior to baseline assessments
  • Relocation to another region during the trial.
  • If the child not are able to demonstrate sufficient co-operation and cognitive understanding to participate in the IGA.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern Denmark - Odense University Hospital

Odense, Denmark

Location

Related Publications (2)

  • Fonvig CE, Rasmussen HM, Overgaard S, Holsgaard-Larsen A. Effectiveness of instrumented gait analysis in interdisciplinary interventions on parents' perception of family-centered service and on gross motor function in children with cerebral palsy: a randomized controlled trial. BMC Pediatr. 2020 Sep 1;20(1):411. doi: 10.1186/s12887-020-02315-2.

    PMID: 32873289DERIVED

  • Rasmussen HM, Pedersen NW, Overgaard S, Hansen LK, Dunkhase-Heinl U, Petkov Y, Engell V, Baker R, Holsgaard-Larsen A. The use of instrumented gait analysis for individually tailored interdisciplinary interventions in children with cerebral palsy: a randomised controlled trial protocol. BMC Pediatr. 2015 Dec 7;15:202. doi: 10.1186/s12887-015-0520-7.

    PMID: 26643822DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Interventions

MethodsImmunoglobulin A

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Investigative TechniquesImmunoglobulin IsotypesAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Helle Rasmussen, Ph.d. stud.

    University of Southern Denmark and Odense University Hospital

    PRINCIPAL INVESTIGATOR

  • Anders Holsgaard-Larsen, Ph.d.

    University of Southern Denmark and Odense University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.d. Student

Study Record Dates

First Submitted

June 2, 2014

First Posted

June 10, 2014

Study Start

August 6, 2014

Primary Completion

July 5, 2017

Study Completion

July 5, 2017

Last Updated

April 6, 2018

Record last verified: 2018-04

Locations

DK(1)