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

February 22, 2024 updated by: Kaat Desloovere, Universitaire Ziekenhuizen KU Leuven

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

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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Gent, Belgium, 9000
        • Universiteit Gent
      • Leuven, Belgium, 3000
        • KU Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 11 years (Child)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.
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.

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)
Estimation of muscle morphology parameters by 3D freehand ultrasonography.
baseline, mid- (6 weeks), post-intervention (12-weeks)
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).
baseline, mid- (6 weeks), post-intervention (12-weeks)
Change in isometric muscle strength
Time Frame: baseline, mid- (6 weeks), post-intervention (12-weeks)
Evaluation of isometric muscle strength by Instrumented Weakness Assessment.
baseline, mid- (6 weeks), post-intervention (12-weeks)
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.
baseline, mid- (6 weeks), post-intervention (12-weeks)

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, post-intervention (12 weeks)
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).
baseline, post-intervention (12 weeks)
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
Baseline, post-intervention (12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Kaat Desloovere, Dr, KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

February 12, 2019

First Submitted That Met QC Criteria

March 4, 2019

First Posted (Actual)

March 5, 2019

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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