search
Back to results

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

Primary Purpose

Cerebral Palsy, Spastic

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Progressive strength training
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy, Spastic focused on measuring Cerebral Palsy, Spastic Cerebral Palsy, Progressive Strength Training, Muscle morphology

Eligibility Criteria

5 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Universiteit Gent
  • KU Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Waitlist-control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in muscle size parameter
Estimation of muscle morphology parameters by 3D freehand ultrasonography.
Change in echogenicity intensity
Estimation of echogenicity intensity by 3D freehand ultrasonography on an 8-bit greyscale (256 values).
Change in isometric muscle strength
Evaluation of isometric muscle strength by Instrumented Weakness Assessment.
Change in functional muscle strength
Evaluation of functional muscle strength by the Adapted Functional Strength measure.

Secondary Outcome Measures

Change in gross motor function
Evaluation of gross motor function by the Gross Motor Function Measure.

Full Information

First Posted
February 12, 2019
Last Updated
July 19, 2021
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
KU Leuven, University Ghent, Queen Fabiola Children's University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03863197
Brief Title
Progressive Supervised Home-based Strength Training in Children With Spastic Cerebral Palsy
Official Title
Treatment Algorithms Based on Muscle and Tendon Morphology - Progressive Supervised Home-based Strength Training in Children With Spastic Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
KU Leuven, University Ghent, Queen Fabiola Children's University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Spastic
Keywords
Cerebral Palsy, Spastic Cerebral Palsy, Progressive Strength Training, Muscle morphology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized controlled trial with waitlist control group
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist-control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Progressive strength training
Intervention Description
Progressive Supervised Home-based Strength Training
Primary Outcome Measure Information:
Title
Change in muscle size parameter
Description
Estimation of muscle morphology parameters by 3D freehand ultrasonography.
Time Frame
baseline, mid- (6 weeks), post-intervention (12-weeks)
Title
Change in echogenicity intensity
Description
Estimation of echogenicity intensity by 3D freehand ultrasonography on an 8-bit greyscale (256 values).
Time Frame
baseline, mid- (6 weeks), post-intervention (12-weeks)
Title
Change in isometric muscle strength
Description
Evaluation of isometric muscle strength by Instrumented Weakness Assessment.
Time Frame
baseline, mid- (6 weeks), post-intervention (12-weeks)
Title
Change in functional muscle strength
Description
Evaluation of functional muscle strength by the Adapted Functional Strength measure.
Time Frame
baseline, mid- (6 weeks), post-intervention (12-weeks)
Secondary Outcome Measure Information:
Title
Change in gross motor function
Description
Evaluation of gross motor function by the Gross Motor Function Measure.
Time Frame
baseline, post-intervention (12 weeks)
Other Pre-specified Outcome Measures:
Title
Change in quality of life
Description
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.
Time Frame
baseline, post-intervention (12 weeks)
Title
Change in Functionality
Description
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).
Time Frame
baseline, post-intervention (12 weeks)
Title
Change in patient reported physical function
Description
The perceived level of physical functioning is assessed by the Activities Scale for Kids
Time Frame
Baseline, post-intervention (12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaat Desloovere, Dr
Organizational Affiliation
KU Leuven
Official's Role
Study Director
Facility Information:
Facility Name
Universiteit Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
KU Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36267577
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs