Progressive Supervised Home-based Strength Training in Children With Spastic Cerebral Palsy

Cerebral Palsy, Spastic Clinical Trial

Official title:

Treatment Algorithms Based on Muscle and Tendon Morphology - Progressive Supervised Home-based Strength Training in Children With Spastic Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03863197
• Other study ID #: S59945
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: June 1, 2021

Study information

• Verified date: February 2024
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 11 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy, Spastic
• Muscle Spasticity
• Paralysis

Intervention

Behavioral:
• Progressive strength training
Progressive Supervised Home-based Strength Training

Locations

Country	Name	City	State
Belgium	Universiteit Gent	Gent
Belgium	KU Leuven	Leuven

Sponsors (4)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	KU Leuven, Queen Fabiola Children's University Hospital, University Ghent

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

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 effect — View Citation

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. F — View Citation

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 ne — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in quality of life	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.	baseline, post-intervention (12 weeks)
Other	Change in Functionality	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).	baseline, post-intervention (12 weeks)
Other	Change in patient reported physical function	The perceived level of physical functioning is assessed by the Activities Scale for Kids	Baseline, post-intervention (12 weeks)
Primary	Change in muscle size parameter	Estimation of muscle morphology parameters by 3D freehand ultrasonography.	baseline, mid- (6 weeks), post-intervention (12-weeks)
Primary	Change in echogenicity intensity	Estimation of echogenicity intensity by 3D freehand ultrasonography on an 8-bit greyscale (256 values).	baseline, mid- (6 weeks), post-intervention (12-weeks)
Primary	Change in isometric muscle strength	Evaluation of isometric muscle strength by Instrumented Weakness Assessment.	baseline, mid- (6 weeks), post-intervention (12-weeks)
Primary	Change in functional muscle strength	Evaluation of functional muscle strength by the Adapted Functional Strength measure.	baseline, mid- (6 weeks), post-intervention (12-weeks)
Secondary	Change in gross motor function	Evaluation of gross motor function by the Gross Motor Function Measure.	baseline, post-intervention (12 weeks)