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

NCT01357954 | Completed

• 1 other identifier: HVH-DJC-1-2011
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

Postural control; Targeted Training; Gross motor function; Cerebral palsy

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Gross Motor Function Measure at 6 months

  Baseline, 6 months

Secondary Outcomes (9)

• Change from baseline in Pediatric Evaluation of Disability Inventory (PEDI)at 6 months

  Baseline, 6 months

• Change from baseline in thickness of the erector spinae muscles measured with ultrasound at 6 months

  Baseline, 6 months

• Change from baseline in seated sway at 6 months

  Baseline, 6 months

• Degree of achievement of a goal set at baseline using a modified Goal Attainment Scale (GAS)

  6 months

• Change from baseline in Pediatric Evaluation of Disability Inventory (PEDI)at 12 months

  Baseline, 12 months

Study Arms (2)

Targeted Training

EXPERIMENTAL

Other: Targeted Training

Control

OTHER

Other: Regular physiotherapy

Interventions

Regular physiotherapy OTHER

The child's regular physiotherapy

Also known as: Physiotherapy

Control

Targeted Training OTHER

Targeted training, 5 days a week for 6 months, up to 30 minutes a day

Also known as: The Movement Centre

Targeted Training

Eligibility Criteria

• Age: 2 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Hvidovre University Hospital

Hvidovre, Copenhagen, DK-2650, Denmark

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Derek J Curtis, PT MSc

  Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

• Stig Sonne-Holm, Dr Med

  Hvidovre University Hospital

  STUDY DIRECTOR

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: Research Physiotherapist, Hvidovre University Hospital.

Study Record Dates

• First Submitted: May 6, 2011
• First Posted: May 23, 2011
• Study Start: June 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2013
• Last Updated: August 5, 2020

Record last verified: 2020-08

Locations

DK (1)