Cerebral PalsyCPinMotionNCT02160457
Gait Analysis and Interdisciplinary Interventions for Children With Cerebral Palsy
A study testing Intervention with IGA in people with Cerebral Palsy, run by University of Southern Denmark at 1 site in Denmark.
Trial 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'. Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Intervention with IGA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 6 Aug 2014to 5 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Spastic Cerebral palsy
- Gross Motor Function Classification System levels I or II.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University of Southern Denmark - Odense University Hospital
Odense
About this study
Official title: Instrumented Gait Analysis and Individually Tailored Interdisciplinary Interventions for Children With Cerebral Palsy: A Randomized Controlled Trial
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'.
Read the detailed description
Children with cerebral palsy (CP) who walk independently often have an altered gait pattern. Interdisciplinary interventions in terms of orthopaedic surgery, spasticity management, physical therapy and orthotics aim to improve the gait pattern. Standardised measurements are used in the Cerebral Palsy follow-Up Program to assess walking. However, these measurements do not describe features in the gait pattern reflecting underlying neuro-musculoskeletal impairments. This can be done with instrumented 3-dimensional gait analysis (IGA). It has never been investigated whether interdisciplinary interventions designed to address impairments identified by IGA result in improved gait pattern compared with 'care as usual' without IGA in children with CP. The aim of this study is to test the hypothesis, that improvements in gait pattern following individually tailored interventions guided by IGA are superior to those used in 'care as usual'.
A prospective, single blind, randomised, parallel group study will be conducted. Participants will be recruited from the Cerebral Palsy follow-Up Program. Children aged 5 to 9 years with spastic CP, classified at Gross Motor Function Classification System levels I or II will be included. The interventions under investigation are 1) Individually tailored interdisciplinary intervention addressing impairments identified by IGA and 2) 'care as usual' (interdisciplinary interventions without IGA). The primary outcome is gait pattern measured by the Gait Deviation Index. Secondary outcome measures are, walking performance and patient-reported outcomes of functional mobility, health-related quality of life and overall health, pain and participation. Explorative outcome measures include walking performance, gait pattern, behavior of health care providers and the applied interventions. The primary endpoint for assessing the outcome of the two interventions will be 52 weeks after start of intervention. A follow up will also be performed at 26 weeks after start of intervention; however, exclusively for the patient-reported outcomes.
To our knowledge, this is the first randomised controlled trial comparing the effects of an individually tailored interdisciplinary intervention designed to address impairments identified by IGA versus 'care as usual' in children with CP. Consequently, the study will provide novel evidence for the use of IGA in interdisciplinary interventions.
- Conditions
- Cerebral Palsy
- Being tested
- Intervention with IGA
- Keywords
- Cerebral palsy, Instrumented gait analysis, Gait Deviation Index
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention with IGAOther
Also called Vicon T40 system, Vicon, Oxford, UK, Advanced Mechanical Technology Inc. (AMTI), OR6-7-1000, Watertown, USA
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:
- Instrumented gait analysis (data collection with a 8-camera Vicon T40 system (Vicon, Oxford, UK) and 2 force plates (AMTI, OR6-7-1000)
- Impairment-Focused Interpretation
- Recommendation for interdisciplinary interventions
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 52 weeks
Secondary outcomes (7)
Change from baseline in 1-minute walk test
Walking performance is assessed with the 1-minute walk test. The test measure the distance in meters, when the child walks as fast as possible.
Measured: Baseline, 52 weeks
Change from baseline in Mobility Scale of the Pediatric Evaluation of Disability Inventory
The Mobility Scale of the Pediatric Evaluation of Disability Inventory evaluates the child's functional mobility in everyday activities with regard to functional skills and caregiver assistance. The Paediatric Evaluation of Disability Inventory will be applied as a parental questionnaire, allowing comparison of the child's functional skills over time for each of the two dimensions.
Measured: Baseline, 52 weeks
Change from baseline in Pediatric Quality of Life Inventory Cerebral Palsy Module
The Pediatric Quality of Life Inventory Cerebral Palsy Module is a measure of health-related quality of life, specifically designed for children with CP. The Pediatric Quality of Life Inventory Cerebral Palsy Module is based upon the parents' report and measures physical, emotional, social and school functioning.
Measured: Baseline, 52 weeks
Change from baseline in Pediatric Outcome Data Collection Instrument
The Pediatric Outcome Data Collection Instrument assesses overall health, pain and participation in normal daily activities.
Measured: Baseline, 52 weeks
Change from baseline in Mobility Scale of the Pediatric Evaluation of Disability Inventory
The Mobility Scale of the Pediatric Evaluation of Disability Inventory evaluates the child's functional mobility in everyday activities with regard to functional skills and caregiver assistance. The Paediatric Evaluation of Disability Inventory will be applied as a parental questionnaire, allowing comparison of the child's functional skills over time for each of the two dimensions.
Measured: Baseline, 26 weeks
Change from baseline in Pediatric Quality of Life Inventory Cerebral Palsy Module
The Pediatric Quality of Life Inventory Cerebral Palsy Module is a measure of health-related quality of life, specifically designed for children with CP. The Pediatric Quality of Life Inventory Cerebral Palsy Module is based upon the parents' report and measures physical, emotional, social and school functioning.
Measured: Baseline, 26 weeks
Change from baseline in Pediatric Outcome Data Collection Instrument
The Pediatric Outcome Data Collection Instrument assesses overall health, pain and participation in normal daily activities.
Measured: Baseline, 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study start6 Aug 2014
- Primary completion5 Jul 2017
- Study completion5 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Sonderborg Hospital, Sygehus Lillebaelt, Esbjerg Hospital - University Hospital of Southern Denmark, University of Salford, Region of Southern Denmark, Ludvig and Sara Elsass Foundation, Association of Danish Physiotherapists
- Responsible party
- Principal investigator, Helle Mätzke Rasmussen, University of Southern Denmark
- Investigators
- Helle Rasmussen, Ph.d. stud., Principal investigator, University of Southern Denmark and Odense University HospitalAnders Holsgaard-Larsen, Ph.d., Study chair, University of Southern Denmark and Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160457
- Sponsor's protocol ID
- S-20120162
- Acronym
- CPinMotion
- Status last verified
- Apr 2018
- First submitted
- 2 Jun 2014
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32873289Rasmussen 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.
PubMed 26643822
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Instrumented Gait Analysis and Individually Tailored Interdisciplinary Interventions for Children With Cerebral Palsy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02160457
- Acronym / sponsor ID
- CPinMotion / S-20120162
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy, Instrumented gait analysis, Gait Deviation Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital, Sonderborg Hospital, Sygehus Lillebaelt, Esbjerg Hospital - University Hospital of Southern Denmark, University of Salford, Region of Southern Denmark, Ludvig and Sara Elsass Foundation, Association of Danish Physiotherapists
- Study start
- 6 Aug 2014 (actual)
- Primary completion
- 5 Jul 2017 (actual)
- Study completion
- 5 Jul 2017 (actual)
- First posted
- 10 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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'.
Detailed description
Children with cerebral palsy (CP) who walk independently often have an altered gait pattern. Interdisciplinary interventions in terms of orthopaedic surgery, spasticity management, physical therapy and orthotics aim to improve the gait pattern. Standardised measurements are used in the Cerebral Palsy follow-Up Program to assess walking. However, these measurements do not describe features in the gait pattern reflecting underlying neuro-musculoskeletal impairments. This can be done with instrumented 3-dimensional gait analysis (IGA). It has never been investigated whether interdisciplinary interventions designed to address impairments identified by IGA result in improved gait pattern compared with 'care as usual' without IGA in children with CP. The aim of this study is to test the hypothesis, that improvements in gait pattern following individually tailored interventions guided by IGA are superior to those used in 'care as usual'.
A prospective, single blind, randomised, parallel group study will be conducted. Participants will be recruited from the Cerebral Palsy follow-Up Program. Children aged 5 to 9 years with spastic CP, classified at Gross Motor Function Classification System levels I or II will be included. The interventions under investigation are 1) Individually tailored interdisciplinary intervention addressing impairments identified by IGA and 2) 'care as usual' (interdisciplinary interventions without IGA). The primary outcome is gait pattern measured by the Gait Deviation Index. Secondary outcome measures are, walking performance and patient-reported outcomes of functional mobility, health-related quality of life and overall health, pain and participation. Explorative outcome measures include walking performance, gait pattern, behavior of health care providers and the applied interventions. The primary endpoint for assessing the outcome of the two interventions will be 52 weeks after start of intervention. A follow up will also be performed at 26 weeks after start of intervention; however, exclusively for the patient-reported outcomes.
To our knowledge, this is the first randomised controlled trial comparing the effects of an individually tailored interdisciplinary intervention designed to address impairments identified by IGA versus 'care as usual' in children with CP. Consequently, the study will provide novel evidence for the use of IGA in interdisciplinary interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention with IGA | Experimental | Other: Intervention with IGAIndividually 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) |
| 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). |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Spastic Cerebral palsy
- Gross Motor Function Classification System levels I or II.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention with IGAAlso: Vicon T40 system, Vicon, Oxford, UK, Advanced Mechanical Technology Inc. (AMTI), OR6-7-1000, Watertown, USAIndividually 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. | Other | Intervention with IGA |
Primary outcome
Change from baseline in Gait Deviation Index
Time frame: Baseline, 52 weeks
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.
7 secondary outcomes
Change from baseline in 1-minute walk test
Time frame: Baseline, 52 weeks
Change from baseline in Mobility Scale of the Pediatric Evaluation of Disability Inventory
Time frame: Baseline, 52 weeks
Change from baseline in Pediatric Quality of Life Inventory Cerebral Palsy Module
Time frame: Baseline, 52 weeks
Change from baseline in Pediatric Outcome Data Collection Instrument
Time frame: Baseline, 52 weeks
Change from baseline in Mobility Scale of the Pediatric Evaluation of Disability Inventory
Time frame: Baseline, 26 weeks
Change from baseline in Pediatric Quality of Life Inventory Cerebral Palsy Module
Time frame: Baseline, 26 weeks
Change from baseline in Pediatric Outcome Data Collection Instrument
Time frame: Baseline, 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
- Derived from this study: PubMed 32873289Fonvig 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.
- Derived from this study: PubMed 26643822Rasmussen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helle Rasmussen, Ph.d. stud. principal investigator
University of Southern Denmark and Odense University Hospital
Anders Holsgaard-Larsen, Ph.d. study chair
University of Southern Denmark and Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention with IGA in people with Cerebral Palsy, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Gait Deviation Index (time frame: Baseline, 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02160457, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2018.