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The Efficacy of Targeted Training on the Postural Control and Gross Motor Function in Children With Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Regular physiotherapy
Targeted Training
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Postural control, Targeted Training, Gross motor function, Cerebral palsy

Eligibility Criteria

2 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis of CP made by a neuro-pediatric physician experienced in assessment and diagnosis of CP
  • GMFCS level III, IV and V,
  • the child cannot walk without assistance,
  • age 2-15 year,
  • no joint deformity or contracture around the "Targeted" joint
  • not a candidate for surgery or other medical treatment that affects motor skills while participating in the project
  • trunk control problems.

Exclusion Criteria:

  • uncontrolled epilepsy
  • surgery within 12 months of the study start
  • Botulinum toxin within 2 months of study start
  • Lack of personnel resources to treat the child at their school/kindergarten

Sites / Locations

  • Hvidovre University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Targeted Training

Control

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in Gross Motor Function Measure at 6 months

Secondary Outcome Measures

Change from baseline in Pediatric Evaluation of Disability Inventory (PEDI)at 6 months
Change from baseline in thickness of the erector spinae muscles measured with ultrasound at 6 months
Change from baseline in seated sway at 6 months
Degree of achievement of a goal set at baseline using a modified Goal Attainment Scale (GAS)
Change from baseline in Pediatric Evaluation of Disability Inventory (PEDI)at 12 months
Change from baseline in thickness of the erector spinae muscles measured with ultrasound at 12 months
Change from baseline in seated sway at 12 months
Degree of achievement of a goal set at baseline using a modified Goal Attainment Scale (GAS)
Change from baseline in Gross Motor Function Measure at 12 months

Full Information

First Posted
May 6, 2011
Last Updated
August 3, 2020
Sponsor
Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01357954
Brief Title
The Efficacy of Targeted Training on the Postural Control and Gross Motor Function in Children With Cerebral Palsy
Official Title
The Efficacy of Targeted Training on the Postural Control and Gross Motor Function in Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The project aims to test the effectiveness and explore the possibility of performing a novel therapeutic approach, targeting to increase strength and coordination around the trunk, giving a more active and functional seating and head control in those children with cerebral palsy (CP) who are wheelchair users. The project will also try to determine the muscle physiological effect of treatment using indirect measures of strength in the spinal musculature.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Postural control, Targeted Training, Gross motor function, Cerebral palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Targeted Training
Arm Type
Experimental
Arm Title
Control
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Regular physiotherapy
Other Intervention Name(s)
Physiotherapy
Intervention Description
The child's regular physiotherapy
Intervention Type
Other
Intervention Name(s)
Targeted Training
Other Intervention Name(s)
The Movement Centre
Intervention Description
Targeted training, 5 days a week for 6 months, up to 30 minutes a day
Primary Outcome Measure Information:
Title
Change from baseline in Gross Motor Function Measure at 6 months
Time Frame
Baseline, 6 months
Secondary Outcome Measure Information:
Title
Change from baseline in Pediatric Evaluation of Disability Inventory (PEDI)at 6 months
Time Frame
Baseline, 6 months
Title
Change from baseline in thickness of the erector spinae muscles measured with ultrasound at 6 months
Time Frame
Baseline, 6 months
Title
Change from baseline in seated sway at 6 months
Time Frame
Baseline, 6 months
Title
Degree of achievement of a goal set at baseline using a modified Goal Attainment Scale (GAS)
Time Frame
6 months
Title
Change from baseline in Pediatric Evaluation of Disability Inventory (PEDI)at 12 months
Time Frame
Baseline, 12 months
Title
Change from baseline in thickness of the erector spinae muscles measured with ultrasound at 12 months
Time Frame
Baseline, 12 months
Title
Change from baseline in seated sway at 12 months
Time Frame
Baseline, 12 months
Title
Degree of achievement of a goal set at baseline using a modified Goal Attainment Scale (GAS)
Time Frame
12 months
Title
Change from baseline in Gross Motor Function Measure at 12 months
Time Frame
Baseline, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of CP made by a neuro-pediatric physician experienced in assessment and diagnosis of CP GMFCS level III, IV and V, the child cannot walk without assistance, age 2-15 year, no joint deformity or contracture around the "Targeted" joint not a candidate for surgery or other medical treatment that affects motor skills while participating in the project trunk control problems. Exclusion Criteria: uncontrolled epilepsy surgery within 12 months of the study start Botulinum toxin within 2 months of study start Lack of personnel resources to treat the child at their school/kindergarten
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Derek J Curtis, PT MSc
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stig Sonne-Holm, Dr Med
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Hvidovre University Hospital
City
Hvidovre
State/Province
Copenhagen
ZIP/Postal Code
DK-2650
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

The Efficacy of Targeted Training on the Postural Control and Gross Motor Function in Children With Cerebral Palsy

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