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| Name | Class |
|---|---|
| KU Leuven | OTHER |
| University Ghent | OTHER |
| Queen Fabiola Children's University Hospital | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | 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. |
|
| Waitlist-control group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progressive strength training | Behavioral | Progressive Supervised Home-based Strength Training |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Muscle Size Parameter | Estimation of muscle volume by 3D freehand ultrasonography. | baseline, post-intervention (12-weeks) |
| Change in Muscle Length | Estimation of muscle length parameters by 3D freehand ultrasonography from origo to muscle tendon junction. | baseline, post-intervention (12-weeks) |
| Change in Echogenicity Intensity | Estimation of echogenicity intensity by 3D freehand ultrasonography on an 8-bit greyscale (256 values ranging from 0 to 255). Echogenicity intensity was defined over the whole muscle volume. Echogenicity intensity refers to the brightness of a muscle seen on the ultrasound image, which reflects how much sound is being bounced back (or "echoed") by the tissue. Higher echo-intensity (i.e., higher values) often indicates increased fat or fibrous tissue within the muscle and is therefore seen as a worse outcome. Whereas low echo-intensity (i.e., lower values) indicate less non-muscular tissue in the muscle, therefor higher quality and a better outcome. | baseline, post-intervention (12-weeks) |
| Change in Isometric Muscle Strength | Evaluation of isometric muscle strength by Instrumented Weakness Assessment. | baseline, post-intervention (12-weeks) |
| Change in Functional Muscle Strength - Muscle Endurance | Evaluation of functional muscle strength by 30-sec maximum repetition tests of the Adapted Functional Strength measure. For unilateral exercises (lateral step-up and unilateral heel raise) all affected legs were assessed. | baseline, post-intervention (12-weeks) |
| Change in Functional Muscle Strength - Maximum Jumping Distance |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gross Motor Function | Evaluation of gross motor function by the Gross Motor Function Measure (GMFM) item set. The GMFM is a standardized observational tool used to assess motor function in children with cerebral palsy by evaluating specific physical tasks across five areas: lying & rolling, sitting, crawling & kneeling, standing, and walking/running/jumping. Each item is scored on a 4-point scale: 0 (does not initiate), 1 (initiates but completes less than 10%), 2 (partially completes, 10% to less than 100%), and 3 (fully completes). Higher scores indicate better gross motor function, with a maximum of 66. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Change in Functionality |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kaat Desloovere, Dr | KU Leuven | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universiteit Gent | Ghent | 9000 | Belgium | |||
| KU Leuven |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34381414 | Result | 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. | |
| 36267577 |
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All children aged 5-11 years old were extracted from the database of the CP reference center Leuven (n=342) and screened based on gross motor function classification system level and type of CP. The appointments at the hospital were checked monthly to further screen potential participants (±10% eligible every month, part of the n=342). Additionally, pediatric physiotherapists at private practices and special needs schools were consulted for potential participants (n=6 not followed in Leuven).
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | During 12 weeks, 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 sessions per week will be performed under the supervision of the physical therapist, whilst the remaining sessions will be conducted at home. The principal investigator and training programs closely monitor progression are adjusted if necessary. Progressive strength training: Progressive Supervised Home-based Strength Training |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
For parameters that could be assessed per leg, both legs of bilaterally affected participants were included and only the affected leg of unilaterally affected participants.
| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | During 12 weeks, 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 sessions per week will be performed under the supervision of the physical therapist, whilst the remaining sessions will be conducted at home. The principal investigator and training programs closely monitor progression are adjusted if necessary. Progressive strength training: Progressive Supervised Home-based Strength Training |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Muscle Size Parameter | Estimation of muscle volume by 3D freehand ultrasonography. | There were some missing data due to 3DfUS reconstructions that could not be (fully) analyzed because of technical errors, isometric and functional strength tests that could not be assessed due to inability of the participant and missing anthropometric information. | Posted | Mean | 95% Confidence Interval | milliliters | baseline, post-intervention (12-weeks) | Affected legs | Affected legs |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | During 12 weeks, 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 sessions per week will be performed under the supervision of the physical therapist, whilst the remaining sessions will be conducted at home. The principal investigator and training programs closely monitor progression are adjusted if necessary. Progressive strength training: Progressive Supervised Home-based Strength Training |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| muscle cramp or pain, joint pain and general discomfort from the weighted vest | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Britta Hanssen | KU Leuven | +3216341295 | britta.hanssen@kuleuven.be |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 1, 2021 | May 6, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Randomized controlled trial with waitlist control group
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Evaluation of standing long jump by the Adapted Functional Strength measure. |
| baseline, post-intervention (12-weeks) |
| baseline, post-intervention (12 weeks) |
| Change in Walking Capacity | Evaluation of walking capacity by assessing the distance covered during the 1-minute walking test | 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 | The perceived level of physical functioning is assessed by the Activities Scale for Kids | Baseline, post-intervention (12 weeks) |
| Leuven |
| 3000 |
| Belgium |
| 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. |
| 36338500 | Result | 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. |
| 40098309 | Result | Vandekerckhove I, Hanssen B, Peeters N, Dewit T, De Beukelaer N, Van den Hauwe M, De Waele L, Van Campenhout A, De Groote F, Desloovere K. Anthropometric-related percentile curves for muscle size and strength of lower limb muscles of typically developing children. J Anat. 2025 Aug;247(2):348-362. doi: 10.1111/joa.14241. Epub 2025 Mar 17. |
| Did not receive intervention (inability to cooperate with assessment or cancellation due to Covid) |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Legs |
|
| Participants |
| Participants |
|
|
| Age, Continuous | Mean | Standard Deviation | years | Participants |
|
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
|
| Region of Enrollment | Number | participants | Participants |
|
|
| Involvement | Count of Participants | Participants | Participants |
|
|
| Gross motor function classification system | The Gross Motor Function Classification System (GMFCS) is a five-level scale used to describe the movement abilities of children and youth with cerebral palsy, ranging from Level I (most independent) to Level V (most limited mobility). Children with levels I to III were included in this study, indicating children who are ambulatory. | Count of Participants | Participants | Participants |
|
|
| Weight | Mean | Standard Deviation | kilogram | Participants |
|
|
| Height | Mean | Standard Deviation | centimeter | Participants |
|
|
| Fibula length | Mean | Standard Deviation | millimeter | Legs |
|
|
| Selective control assessment of the lower extremity (score out of 10) | The Selective Control Assessment of the Lower Extremity (SCALE) is a clinical tool used to measure how well someone with cerebral palsy can intentionally move individual joints in their legs without unwanted movement in other parts. The SCALE consists of 5 subtests (hip, knee, ankle, subtalar joint and toes) each scored a 0, 1 or 2. The total score for one leg ranges therefor from 0 to 10. | Mean | Standard Deviation | units on a scale | Legs |
|
|
| OG001 | 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 | Change in Muscle Length | Estimation of muscle length parameters by 3D freehand ultrasonography from origo to muscle tendon junction. | There were some missing data due to 3DfUS reconstructions that could not be (fully) analyzed because of technical errors, isometric and functional strength tests that could not be assessed due to inability of the participant and missing anthropometric information. | Posted | Mean | 95% Confidence Interval | millimeters | baseline, post-intervention (12-weeks) | Affected legs | Affected legs |
|
|
|
|
| Primary | Change in Echogenicity Intensity | Estimation of echogenicity intensity by 3D freehand ultrasonography on an 8-bit greyscale (256 values ranging from 0 to 255). Echogenicity intensity was defined over the whole muscle volume. Echogenicity intensity refers to the brightness of a muscle seen on the ultrasound image, which reflects how much sound is being bounced back (or "echoed") by the tissue. Higher echo-intensity (i.e., higher values) often indicates increased fat or fibrous tissue within the muscle and is therefore seen as a worse outcome. Whereas low echo-intensity (i.e., lower values) indicate less non-muscular tissue in the muscle, therefor higher quality and a better outcome. | There were some missing data due to 3DfUS reconstructions that could not be (fully) analyzed because of technical errors, isometric and functional strength tests that could not be assessed due to inability of the participant and missing anthropometric information. | Posted | Mean | 95% Confidence Interval | arbitrary units | baseline, post-intervention (12-weeks) | legs | legs |
|
|
|
|
| Primary | Change in Isometric Muscle Strength | Evaluation of isometric muscle strength by Instrumented Weakness Assessment. | There were some missing data due to 3DfUS reconstructions that could not be (fully) analyzed because of technical errors, isometric and functional strength tests that could not be assessed due to inability of the participant and missing anthropometric information. | Posted | Mean | 95% Confidence Interval | Newton meters | baseline, post-intervention (12-weeks) | legs | legs |
|
|
|
|
| Primary | Change in Functional Muscle Strength - Muscle Endurance | Evaluation of functional muscle strength by 30-sec maximum repetition tests of the Adapted Functional Strength measure. For unilateral exercises (lateral step-up and unilateral heel raise) all affected legs were assessed. | There were some missing data due to 3DfUS reconstructions that could not be (fully) analyzed because of technical errors, isometric and functional strength tests that could not be assessed due to inability of the participant and missing anthropometric information. | Posted | Mean | 95% Confidence Interval | repetitions | baseline, post-intervention (12-weeks) | legs | legs |
|
|
|
|
| Secondary | Change in Gross Motor Function | Evaluation of gross motor function by the Gross Motor Function Measure (GMFM) item set. The GMFM is a standardized observational tool used to assess motor function in children with cerebral palsy by evaluating specific physical tasks across five areas: lying & rolling, sitting, crawling & kneeling, standing, and walking/running/jumping. Each item is scored on a 4-point scale: 0 (does not initiate), 1 (initiates but completes less than 10%), 2 (partially completes, 10% to less than 100%), and 3 (fully completes). Higher scores indicate better gross motor function, with a maximum of 66. | There were some missing data due to 3DfUS reconstructions that could not be (fully) analyzed because of technical errors, isometric and functional strength tests that could not be assessed due to inability of the participant. and missing anthropometric information. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, post-intervention (12 weeks) |
|
|
|
|
| Other Pre-specified | 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. | Not Posted | baseline, post-intervention (12 weeks) | Participants |
| Other Pre-specified | 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). | Not Posted | baseline, post-intervention (12 weeks) | Participants |
| Other Pre-specified | Change in Patient Reported Physical Function | The perceived level of physical functioning is assessed by the Activities Scale for Kids | Not Posted | Baseline, post-intervention (12 weeks) | Participants |
| Primary | Change in Functional Muscle Strength - Maximum Jumping Distance | Evaluation of standing long jump by the Adapted Functional Strength measure. | There were some missing data due to 3DfUS reconstructions that could not be (fully) analyzed because of technical errors, isometric and functional strength tests that could not be assessed due to inability of the participant and missing anthropometric information. | Posted | Mean | 95% Confidence Interval | distance in centimer | baseline, post-intervention (12-weeks) |
|
|
|
|
| Secondary | Change in Walking Capacity | Evaluation of walking capacity by assessing the distance covered during the 1-minute walking test | There were some missing data due to 3DfUS reconstructions that could not be (fully) analyzed because of technical errors, isometric and functional strength tests that could not be assessed due to inability of the participant. and missing anthropometric information. | Posted | Mean | 95% Confidence Interval | distance in meters | baseline, post-intervention (12 weeks) |
|
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 10 |
| 26 |
| EG001 | 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. | 0 | 22 | 0 | 22 | 0 | 22 |
|
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| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Level III |
|
|
|
|
| Muscle length - semitendinosis |
|
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| Muscle length - medial gastrocnemius |
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| Echo-intensity - semitendinosus |
|
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| Echo-intensity - medial gastrocnemius |
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| Knee flexion strength |
|
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| Plantar flexion strength |
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| Lateral step-up |
|
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| Bilateral heel raise |
|
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| Unilateral heel raise |
|
|