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Progressive Supervised Home-based Strength Training 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: NCT03863197
Recruitment Status : Recruiting
First Posted : March 5, 2019
Last Update Posted : November 30, 2020
KU Leuven
University Ghent
Queen Fabiola Children's University Hospital
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:
A randomized controlled trail will be carried out to investigate the effect of a 12-week supervised home-based progressive strength intervention in children with spastic cerebral palsy aged 5-11 years. The results of this strength intervention aiming for increased strength and muscle hypertrophy will serve as input for a clinical decision making framework based on muscle and tendon architecture.

Condition or disease Intervention/treatment Phase
Cerebral Palsy, Spastic Behavioral: Progressive strength training Not Applicable

Detailed Description:

Background: The alterations of morphological muscle and tendon properties are a primary determinant of the pathological muscle behaviour in spastic cerebral palsy (SCP). As treatments aim to reduce the progressive secondary problems, they are mainly directed at the muscle level. Muscle morphology features like volume, fascicle architecture and tendon properties are all responsive to treatment, but these treatment responses seem to be both patient and muscle-specific. Therefore, objective tools and protocols are needed for the evaluation of morphological muscle and tendon (MMT) properties in routine clinical practice. These are required to guide the patient-specific selection of appropriate, rationalized treatment choices and to determine the impact of these treatments on the MMT properties, the muscular impairment and function in children with SCP.

This intervention study is one out of three intervention studies focused on defining the effects of conservative treatments (strengthening, stretching and botulinum toxin injections) on muscle and tendon architecture. In this phase of the Treatment Algorithms based on Muscle and Tendon Morphology (TAMTA) project, we aim to develop specific guidelines for these treatment options linked to the MMT evaluation protocol. To achieve this goal, prediction models based on baseline MMT parameters for the prognosis of specific treatment outcomes will be developed from the data of the three intervention studies.

Aim: (1) determine whether the 12-week program of targeted progressive strengthening of the plantar flexors, the knee flexors and extensors leads to changes in the MMT properties of medial gastrocnemius, semitendinosus and rectus femoris, in the muscle strength and in gross motor function; and (2) determine the correlation between baseline MMT properties and the changes in the outcome parameters.

Methods/Design: A randomized controlled trial will be conducted in 40 ambulatory children with a confirmed diagnosis of SCP between 5 and 11 years of age. Participants will be randomized to the intervention group (who will additionally receive the strengthening program while continuing their usual care) or to the waitlist-control group (who will continue their usual care without additional treatment) using the randomization by minimization method (with influencing characteristics age and GMFCS level). Participants in the control group will be able to participate in the intervention after the control period. The MMT parameters of the medial gastrocnemius, tibialis anterior, semitendinosus and rectus femoris and the isometric and functional strength for the 4 related lower limb muscle groups (plantar flexors, dorsiflexors, knee flexors and knee extensors) as well as the gross motor function will be assessed before and after the 12-week program. After 6 weeks a short evaluation of the MMT parameters, isometric and functional strength will take place.

The change in primary outcome parameters before and after training of the intervention group will be compared to the data behaviour of the control group. Secondly, to explore the predictive value of specific baseline MMT parameters on treatment effect, both univariate and multivariate linear regression analyses will be conducted to identify significant predictive variables for the primary outcome parameters.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized controlled trial with waitlist control group
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment Algorithms Based on Muscle and Tendon Morphology - Progressive Supervised Home-based Strength Training in Children With Spastic Cerebral Palsy
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Intervention group
During a 12-week period children receive 3-4 sessions of progressive strength training per week on top of the usual care. All children will be provided with an individualized training program and supporting equipment. One or 2 session per week will be performed under supervision of the physical therapist, whilst the remaining sessions will be performed at home. Progression is closely monitored by the principal investigator and training programs are adjusted if necessary.
Behavioral: Progressive strength training
Progressive Supervised Home-based Strength Training

No Intervention: Waitlist-control group
The waitlist-control group will continue their usual care without additional treatment for 12-weeks, followed by a 12-week period of progressive supervised home-based strength training.

Primary Outcome Measures :
  1. Change in muscle size parameter [ Time Frame: baseline, mid- (6 weeks), post-intervention (12-weeks) ]
    Estimation of muscle morphology parameters by 3D freehand ultrasonography.

  2. Change in echogenicity intensity [ Time Frame: baseline, mid- (6 weeks), post-intervention (12-weeks) ]
    Estimation of echogenicity intensity by 3D freehand ultrasonography on an 8-bit greyscale (256 values).

  3. Change in isometric muscle strength [ Time Frame: baseline, mid- (6 weeks), post-intervention (12-weeks) ]
    Evaluation of isometric muscle strength by Instrumented Weakness Assessment.

  4. Change in functional muscle strength [ Time Frame: baseline, mid- (6 weeks), post-intervention (12-weeks) ]
    Evaluation of functional muscle strength by the Adapted Functional Strength measure.

Secondary Outcome Measures :
  1. Change in gross motor function [ Time Frame: baseline, post-intervention (12 weeks) ]
    Evaluation of gross motor function by the Gross Motor Function Measure.

Other Outcome Measures:
  1. Change in quality of life [ Time Frame: baseline, post-intervention (12 weeks) ]
    Evaluation of quality of life by the CP Quality of Life (CP QOL-Child) questionnaire for children. This questionnaire evaluates quality of life over various domains on a 1-9 scale. A higher score indicates more happiness.

  2. Change in Functionality [ Time Frame: baseline, post-intervention (12 weeks) ]
    The level of functionality and activity is assessed by the Gillette Functional Assessment questionnaire. This parent-reported questionnaire consists of 22 items (0 low function - 10 high function).

  3. Change in patient reported physical function [ Time Frame: Baseline, post-intervention (12 weeks) ]
    The perceived level of physical functioning is assessed by the Activities Scale for Kids

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Confirmed diagnosis of SCP
  • Aged 5-12 years
  • GMFCS levels I-III (GMFCS = Gross Motor Function Classification Score, expressing the overall functional level of impairment)
  • Sufficient cooperation to comprehend and complete the test procedure

Exclusion Criteria:

  • Non-ambulatory
  • Botulinum toxin A injections six months prior to enrollment
  • Lower limb surgery two years prior to enrollment
  • Presence of ataxia or dystonia
  • Cognitive problems that impede measurements
  • Severe co-morbidities (severe epilepsy, non-correctable visual impairment, autism spectrum disorders, mental problems that prevent comprehensiveness of the tasks)

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): NCT03863197

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Contact: Britta Hanssen, MSc +3216341295

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Universiteit Gent Recruiting
Gent, Belgium, 9000
Contact: Christine Van den Broeck, Dr    +32 9 332 69 21   
Contact: Patrick Calders, Dr    +32 9 332 69 15   
KU Leuven Recruiting
Leuven, Belgium, 3000
Contact: Britta Hanssen, MSc    +32 16 3 41295   
Contact: Kaat Desloovere, Dr    +32 16 37 65 07   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
KU Leuven
University Ghent
Queen Fabiola Children's University Hospital
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Study Director: Kaat Desloovere, Dr KU Leuven
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Responsible Party: Universitaire Ziekenhuizen Leuven Identifier: NCT03863197    
Other Study ID Numbers: S59945
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: November 30, 2020
Last Verified: November 2020
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
Keywords provided by Universitaire Ziekenhuizen Leuven:
Cerebral Palsy
Spastic Cerebral Palsy
Progressive Strength Training
Muscle morphology
Additional relevant MeSH terms:
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Muscle Spasticity
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations