The Effects of Intensive Therapy on Trunk and Lower Limbs in Children With Spastic Cerebral Palsy.

Not Applicable

Completed

• Conditions: Cerebral Palsy, Spastic
• Interventions: Other: Functional therapy; Other: Qualitative functional therapy

• Registration Number: NCT03449498
• Lead Sponsor: University Ghent

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.

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2018-02-22
• Study First Submitted QC: 2018-02-22
• Study First Posted: 2018-02-28
• Primary Completion: 2019-09-15
• Study Completion: 2019-09-15
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2023-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Functional therapy	Intensive functional therapy
study group	Qualitative functional therapy	Intensive qualitative functional therapy

Primary Outcome Measures

Name	Time	Method
Quality Function Measurement (QFM) and the Gross Motor Measurement Scale (GMFM)	1h30	The Gross Motor Function Measure (GMFM)25 is used for the evaluation of gross motor function. The GMFM-88 exists of 88 items categorized into five dimensions: Lying \& Rolling (Dim A), Sitting (Dim B), Crawling \& Kneeling (Dim C), Standing (Dim D), and Walking, Running \& Jumping (Dim E). The Quality Function Measure (QFM)26 evaluates the quality of execution of the items of Dim D and E of the GMFM. Five attributes are scored separately by use of video scoring: alignment, coordination, weight shift, stability and dissociated movements.; GMFM: scale ranges fo each item: 0-3 (0 is the minimum score, 3 is the maximum score). There is a total score for all dimensions and a subscore for each dimension, expressed in a percentage. QFM: scale ranges for each qualitative attribute: 0-3 (0 is the minimum score, 3 the maximum score). There is a total score for each qualitative attribute.

Secondary Outcome Measures

Name	Time	Method
Timed Up and Go	5 minutes	Assesses dynamic balance and mobility of the child.
Muscle strength	10 minutes	Daniels and Worthingham's Manual Muscle Testing. Scale ranges: 0-5 (0 is the minimum score, 5 is the maximum score).
Trunk Control Measurement Scale	30 minutes	Trunk control in sitting is evaluated with the Trunk Control Measurement Scale (TCMS). The TCMS evaluates two prime aspects of trunk control during functional activities: (1) being a stable base for upper and lower limb movements, and (2) being an actively moving body segment. It consists of three subscales: 'static sitting balance', 'selective movement control' and 'dynamic reaching'.; Scale range: 0-3 (0 is the minimum score, 3 is the maximum score).
Range of motion (passive and active)	10 minutes	Assessed with a goniometer (degrees) in standardised positions.
Muscle tone	10 minutes	Modified Ashworth Scale, Tardieu Scale. Scale ranges: 0-4 (0 is the maximum score, 4 is the minimum score).
3D-motion analysis system movements of lower limbs and trunk during gait	1h	3D-movement analysis is used to evaluate lower limb and trunk movements during gait. The children walk barefoot over a 10m walkway at self-selected speed, while marker trajectories on trunk and lower limbs are captured by 12 infrared cameras (VICON system). Spatiotemporal and kinematic parameters will be evaluated.
1 Minute Walking Test	5 minutes	Evaluates walking ability and endurance of the child.

Trial Locations

Locations (1)

Ghent University; 🇧🇪 Gent, Belgium