- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03863197
Progressive Supervised Home-based Strength Training in Children With Spastic Cerebral Palsy
Treatment Algorithms Based on Muscle and Tendon Morphology - Progressive Supervised Home-based Strength Training in Children With Spastic Cerebral Palsy
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Gent, Belgium, 9000
- Universiteit Gent
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Leuven, Belgium, 3000
- KU Leuven
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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Progressive Supervised Home-based Strength Training
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in muscle size parameter
Time Frame: baseline, mid- (6 weeks), post-intervention (12-weeks)
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Estimation of muscle morphology parameters by 3D freehand ultrasonography.
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baseline, mid- (6 weeks), post-intervention (12-weeks)
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Change in echogenicity intensity
Time Frame: baseline, mid- (6 weeks), post-intervention (12-weeks)
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Estimation of echogenicity intensity by 3D freehand ultrasonography on an 8-bit greyscale (256 values).
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baseline, mid- (6 weeks), post-intervention (12-weeks)
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Change in isometric muscle strength
Time Frame: baseline, mid- (6 weeks), post-intervention (12-weeks)
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Evaluation of isometric muscle strength by Instrumented Weakness Assessment.
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baseline, mid- (6 weeks), post-intervention (12-weeks)
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Change in functional muscle strength
Time Frame: baseline, mid- (6 weeks), post-intervention (12-weeks)
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Evaluation of functional muscle strength by the Adapted Functional Strength measure.
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baseline, mid- (6 weeks), post-intervention (12-weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in gross motor function
Time Frame: baseline, post-intervention (12 weeks)
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Evaluation of gross motor function by the Gross Motor Function Measure.
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baseline, post-intervention (12 weeks)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in quality of life
Time Frame: baseline, post-intervention (12 weeks)
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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.
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baseline, post-intervention (12 weeks)
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Change in Functionality
Time Frame: baseline, post-intervention (12 weeks)
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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).
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baseline, post-intervention (12 weeks)
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Change in patient reported physical function
Time Frame: Baseline, post-intervention (12 weeks)
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The perceived level of physical functioning is assessed by the Activities Scale for Kids
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Baseline, post-intervention (12 weeks)
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Collaborators and Investigators
Investigators
- Study Director: Kaat Desloovere, Dr, KU Leuven
Publications and helpful links
General Publications
- Hanssen B, Peeters N, Vandekerckhove I, De Beukelaer N, Bar-On L, Molenaers G, Van Campenhout A, Degelaen M, Van den Broeck C, Calders P, Desloovere K. The Contribution of Decreased Muscle Size to Muscle Weakness in Children With Spastic Cerebral Palsy. Front Neurol. 2021 Jul 26;12:692582. doi: 10.3389/fneur.2021.692582. eCollection 2021.
- Hanssen B, Peeters N, De Beukelaer N, Vannerom A, Peeters L, Molenaers G, Van Campenhout A, Deschepper E, Van den Broeck C, Desloovere K. Progressive resistance training for children with cerebral palsy: A randomized controlled trial evaluating the effects on muscle strength and morphology. Front Physiol. 2022 Oct 4;13:911162. doi: 10.3389/fphys.2022.911162. eCollection 2022.
- Verreydt I, Vandekerckhove I, Stoop E, Peeters N, van Tittelboom V, Van de Walle P, Van den Hauwe M, Goemans N, De Waele L, Van Campenhout A, Hanssen B, Desloovere K. Instrumented strength assessment in typically developing children and children with a neural or neuromuscular disorder: A reliability, validity and responsiveness study. Front Physiol. 2022 Oct 19;13:855222. doi: 10.3389/fphys.2022.855222. eCollection 2022. Erratum In: Front Physiol. 2022 Dec 23;13:1120014.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S59945
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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