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

NCT03449498 | Completed

• 1 other identifier: 2017/0678
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy, Spastic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 3D-motion analysis system movements of lower limbs and trunk during gait

  1h

• Range of motion (passive and active)

  10 minutes

• Timed Up and Go

  5 minutes

• 1 Minute Walking Test

  5 minutes

• Muscle tone

  10 minutes

Study Arms (2)

study group

EXPERIMENTAL

Intensive qualitative functional therapy

Other: Qualitative functional therapy

control group

EXPERIMENTAL

Intensive functional therapy

Other: Functional therapy

Interventions

Qualitative functional therapy OTHER

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.

study group

Functional therapy OTHER

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.

control group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Ghent: lead
• KU Leuven: collaborator

Study Sites (1)

Ghent University

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RCT

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: February 28, 2018
• Study Start: June 1, 2017
• Primary Completion: September 15, 2019
• Study Completion: September 15, 2019
• Last Updated: December 18, 2023

Record last verified: 2023-12

Locations

BE (1)