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

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

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 Overview

• Status: Completed
• Conditions: Cerebral Palsy, Spastic
• Intervention / Treatment: Other: Qualitative functional therapy; Other: Functional therapy

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium, 9000
    • Ghent University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study group; Intensive qualitative functional therapy	Other: Qualitative functional therapy; Camps fot children with spastic CP are organised. Each camp consists of 10 days of 6 hours therapy per day. Six functional activities focusing on lower limbs and trunk are performed: walking, stair climbing, balance, transfers, trunk control, and Wii (combination of functional activities in sitting and/or standing). A group of clinical experts composes a set of exercises for each of these activities, however individual adaptations according to the needs and abilities of the child can be still be done. Quality of movement (alignment, weightshift, dissociation, coordination and stability) is hereby very important. The theme 'circus' is used to enhance the motivation of the children.
Experimental: control group; Intensive functional therapy	Other: Functional therapy; Camps fot children with spastic CP are organised. Each camp consists of 10 days of 6 hours therapy per day. Goals are set with the parents and the children. During the camp children work on obtaining these goals in a exclusively functional way.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality Function Measurement (QFM) and the Gross Motor Measurement Scale (GMFM)	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.	1h30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3D-motion analysis system movements of lower limbs and trunk during gait	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.	1h
Range of motion (passive and active)	Assessed with a goniometer (degrees) in standardised positions.	10 minutes
Timed Up and Go	Assesses dynamic balance and mobility of the child.	5 minutes
1 Minute Walking Test	Evaluates walking ability and endurance of the child.	5 minutes
Muscle tone	Modified Ashworth Scale, Tardieu Scale. Scale ranges: 0-4 (0 is the maximum score, 4 is the minimum score).	10 minutes
Muscle strength	Daniels and Worthingham's Manual Muscle Testing. Scale ranges: 0-5 (0 is the minimum score, 5 is the maximum score).	10 minutes
Trunk Control Measurement Scale	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).	30 minutes

Collaborators and Investigators

• Sponsor: University Ghent
• Collaborators: KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): September 15, 2019
• Study Completion (Actual): September 15, 2019

Study Registration Dates

• First Submitted: February 22, 2018
• First Submitted That Met QC Criteria: February 22, 2018
• First Posted (Actual): February 28, 2018

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Cerebral Palsy; Muscle Spasticity
• Other Study ID Numbers: 2017/0678

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No