Clinical trial NCT03449498: The Effects of Intensive Therapy on Trunk and Lower Limbs in Children With Spastic Cerebral Palsy.
Official title: The Effects of Intensive Therapy on Quantitative and Qualitative Parameters of Trunk and Lower Limbs in Children With Spastic Cerebral Palsy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy, Spastic
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: KU Leuven
First posted: 2018-02-28
Enrollment: 48
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: TREATMENT

Brief summary: Research on the effects of physiotherapeutic interventions in children with CP has grown expansively, and shows a wide diversity of techniques and concepts that are used in variable intensity. Until now there is no consensus on the optimal intensity of these interventions to have a positive impact on the activity and participation level of these children. A recent systematic review and meta-analysis already showed evidence for the effect of intensive training of hand function in children with CP, including short bursts of highly intensive therapy. In contrast, studies on the effect of intensive therapy of gross motor function were limited, and training was performed at a lower intensity during a longer period, resulting in effects that are more inconclusive. Moreover, none of the reviewed studies included improvement of trunk control as one of their treatment goals, although it is known that most children with CP experience some problems with trunk control, to a variable extent.

This research project has two aims, i.e. 1) investigating the effect of intensive therapy camps on qualitative and quantitative parameters of lower limbs and trunk; and 2) comparing the effect of two therapeutic approaches, namely a functional approach versus a more qualitative-functional approach on these parameters.

Detailed description: Research on the effects of physiotherapeutic interventions in children with CP has grown expansively, and shows a wide diversity of techniques and concepts that are used in variable intensity. Until now there is no consensus on the optimal intensity of these interventions to have a positive impact on the activity and participation level of these children. A recent systematic review and meta-analysis already showed evidence for the effect of intensive training of hand function in children with CP, including short bursts of highly intensive therapy. In contrast, studies on the effect of intensive therapy of gross motor function were limited, and training was performed at a lower intensity during a longer period, resulting in effects that are more inconclusive. Moreover, none of the reviewed studies included improvement of trunk control as one of their treatment goals, although it is known that most children with CP experience some problems with trunk control, to a variable extent.

This research project has two aims, i.e. 1) investigating the effect of intensive therapy camps on qualitative and quantitative parameters of lower limbs and trunk; and 2) comparing the effect of two therapeutic approaches, namely a functional approach versus a more qualitative-functional approach on these parameters.

Eligibility criteria: Inclusion Criteria:

1. spastic type of CP
2. bilateral motor involvement (both diplegia and quadriplegia)
3. GMFCS-level II and III
4. 6 to 12 years old
5. cognition: able to understand and execute instructions in a proper way and sufficient concentration (both during the measurements as during the camp).

Exclusion Criteria:

1. mixed form of CP (with ataxia or dystonia)
2. Botulinum Toxin-A injections within six months prior to the camp
3. multilevel orthopedic surgery within one year prior to the camp
4. selective dorsal rhizotomy within two years prior to the camp
5. spinal fusion

Primary outcomes:
measure: Quality Function Measurement (QFM) and the Gross Motor Measurement Scale (GMFM)
timeFrame: 1h30
Secondary outcomes:
measure: 3D-motion analysis system movements of lower limbs and trunk during gait
timeFrame: 1h
measure: Range of motion (passive and active)
timeFrame: 10 minutes
measure: Timed Up and Go
timeFrame: 5 minutes
measure: 1 Minute Walking Test
timeFrame: 5 minutes
measure: Muscle tone
timeFrame: 10 minutes
measure: Muscle strength
timeFrame: 10 minutes
measure: Trunk Control Measurement Scale
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Ghent University
Study officials:
References: