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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03449498
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : February 28, 2018
KU Leuven
Information provided by (Responsible Party):
Vakgroeprevaki, 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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy, Spastic Other: Qualitative functional therapy Other: Functional therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: RCT
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Intensive Therapy on Quantitative and Qualitative Parameters of Trunk and Lower Limbs in Children With Spastic Cerebral Palsy.
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : September 15, 2019
Estimated Study Completion Date : September 15, 2019

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Quality Measurement Scale [ Time Frame: 1h30 ]
    Based on the GMFM (Gross Motor Measurement Scale) 5 qualitative parameters are evaluated: alignment, weightshift, dissociation, coordination and stability.

  2. Trunk Control Measurement Scale [ Time Frame: 30 minutes ]
    Static and dynamic sitting balance.

Secondary Outcome Measures :
  1. 3D-motion analysis system movements of lower limbs and trunk during gait [ Time Frame: 1h ]
  2. Clinical outcomes [ Time Frame: 30 minutes ]
    Range of motion (passive and active), muscle tone, muscle strength

  3. Timed Up and Go [ Time Frame: 5 minutes ]
    Assesses dynamic balance and mobility of the child.

  4. 1 Minute Walking Test [ Time Frame: 5 minutes ]
    Evaluates walking ability and endurance of the child

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   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:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03449498

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Contact: Vanessa van Tittelboom 09 332 44 18
Contact: Christine Van den Broeck 09 332 69 21

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Ghent University Recruiting
Gent, Belgium, 9000
Contact: Vanessa van Tittelboom         
Sponsors and Collaborators
University Ghent
KU Leuven

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Responsible Party: Vakgroeprevaki, Professor, University Ghent Identifier: NCT03449498     History of Changes
Other Study ID Numbers: 2017/0678
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cerebral Palsy
Muscle Spasticity
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms