CClinicalTrials.gg
CompletedNCT03449498Updated Dec 18, 2023

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

An interventional study of Qualitative functional therapy and Functional therapy in Cerebral Palsy, Spastic, sponsored by University Ghent. Completed at 1 site in Belgium. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2023-12-18.

Sponsored by University Ghent · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cerebral Palsy, Spastic
03

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    study group

    Intensive qualitative functional therapy

    Other: Qualitative functional therapy

  • Experimental
    control group

    Intensive functional therapy

    Other: Functional therapy

Interventions

  • OtherQualitative 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.

  • OtherFunctional 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.

05

What researchers measure

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.

    Time frame: 1h30

Secondary outcomes

  1. 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.

    Time frame: 1h

  2. Range of motion (passive and active)

    Assessed with a goniometer (degrees) in standardised positions.

    Time frame: 10 minutes

  3. Timed Up and Go

    Assesses dynamic balance and mobility of the child.

    Time frame: 5 minutes

  4. 1 Minute Walking Test

    Evaluates walking ability and endurance of the child.

    Time frame: 5 minutes

  5. Muscle tone

    Modified Ashworth Scale, Tardieu Scale. Scale ranges: 0-4 (0 is the maximum score, 4 is the minimum score).

    Time frame: 10 minutes

  6. Muscle strength

    Daniels and Worthingham's Manual Muscle Testing. Scale ranges: 0-5 (0 is the minimum score, 5 is the maximum score).

    Time frame: 10 minutes

  7. 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).

    Time frame: 30 minutes

06

Study locations

1 site
  • Ghent University
    Gent, 9000, Belgium
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03449498
Lead sponsor
University Ghent
Collaborators
KU Leuven
Responsible party
Sponsor
First posted
Feb 28, 2018
Start date
Jun 1, 2017
Primary completion
Sep 15, 2019
Completion
Sep 15, 2019
Last update
Dec 18, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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