An interventional study of Progressive strength training in Cerebral Palsy, Spastic, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 2 sites in Belgium. Open to participants aged 5 Years to 11 Years. Per ClinicalTrials.gov, last updated 2025-07-08.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Treatment
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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Exclusion Criteria:
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.
Behavioral: Progressive strength training
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.
Progressive Supervised Home-based Strength Training
Change in Muscle Size Parameter
Estimation of muscle volume by 3D freehand ultrasonography.
Time frame: baseline, post-intervention (12-weeks)
Change in Muscle Length
Estimation of muscle length parameters by 3D freehand ultrasonography from origo to muscle tendon junction.
Time frame: 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.
Time frame: baseline, post-intervention (12-weeks)
Change in Isometric Muscle Strength
Evaluation of isometric muscle strength by Instrumented Weakness Assessment.
Time frame: 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.
Time frame: baseline, post-intervention (12-weeks)
Change in Functional Muscle Strength - Maximum Jumping Distance
Evaluation of standing long jump by the Adapted Functional Strength measure.
Time frame: baseline, post-intervention (12-weeks)
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.
Time frame: baseline, post-intervention (12 weeks)
Change in Walking Capacity
Evaluation of walking capacity by assessing the distance covered during the 1-minute walking test
Time frame: baseline, post-intervention (12 weeks)
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.
Time frame: baseline, post-intervention (12 weeks)
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).
Time frame: 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
Time frame: Baseline, post-intervention (12 weeks)
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).
| Milestone | Intervention Group | Waitlist-control Group |
|---|---|---|
| Started | 27 | 22 |
| Completed | 19 | 19 |
| Not completed | 8 | 3 |
| Withdrew: Lost to follow-up | 2 | 3 |
| Withdrew: Withdrawal by subject | 4 | 0 |
| Withdrew: Did not receive intervention (inability to cooperate with assessment or cancellation due to covid) | 2 | 0 |
Estimation of muscle volume by 3D freehand ultrasonography.
| milliliters | Intervention Group | Waitlist-control Group |
|---|---|---|
| Muscle volume - rectus femoris | 3.7 (1.9 to 5.5) | 1.6 (-0.1 to 3.4) |
| Muscle volume - semitendinosis | 1.4 (-0.5 to 3.3) | 0.1 (-1.8 to 2.0) |
| Muscle volume - medial gastrocnemius | 2.0 (0.9 to 3.1) | 0.5 (-0.5 to 1.6) |
Estimation of muscle length parameters by 3D freehand ultrasonography from origo to muscle tendon junction.
| millimeters | Intervention Group | Waitlist-control Group |
|---|---|---|
| Muscle length - rectus femoris | 3.9 (0.0 to 7.7) | 5.5 (1.8 to 9.3) |
| Muscle length - semitendinosis | 3.2 (-1.3 to 7.7) | 3.0 (-1.6 to 7.5) |
| Muscle length - medial gastrocnemius | 3.5 (1.4 to 5.6) | 2.4 (0.3 to 4.4) |
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.
| arbitrary units | Intervention Group | Waitlist-control Group |
|---|---|---|
| Echo-intensity - rectus femoris | -0.3 (-4.6 to 3.9) | -0.1 (-4.2 to 4.1) |
| Echo-intensity - semitendinosus | 3.8 (-1.1 to 8.7) | 3.2 (-1.9 to 8.3) |
| Echo-intensity - medial gastrocnemius | 0.2 (-3.0 to 2.4) | 1.8 (-1.4 to 4.9) |
Evaluation of isometric muscle strength by Instrumented Weakness Assessment.
| Newton meters | Intervention Group | Waitlist-control Group |
|---|---|---|
| Knee extension strength | 2.5 (0.8 to 4.2) | -0.4 (-2.1 to 1.2) |
| Knee flexion strength | 6.0 (3.3 to 8.7) | 0.8 (-1.9 to 3.4) |
| Plantar flexion strength | 3.6 (2.2 to 5.0) | 1.1 (-0.3 to 2.5) |
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.
| repetitions | Intervention Group | Waitlist-control Group |
|---|---|---|
| Sit-to-stand | 2.7 (1.2 to 4.1) | 0.3 (-1.3 to 1.9) |
| Lateral step-up | 2.7 (1.4 to 3.9) | 1.1 (-0.2 to 2.3) |
| Bilateral heel raise | 4.5 (1.9 to 7.1) | 3.6 (1.1 to 6.0) |
| Unilateral heel raise | 9.1 (5.7 to 12.4) | -1.5 (-4.7 to 1.7) |
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.
| score on a scale | Intervention Group | Waitlist-control Group |
|---|---|---|
| Change in Gross Motor Function | 0.7 (-0.6 to 2.1) | 0.3 (-1.1 to 1.8) |
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.
Results for this outcome have not been posted.
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).
Results for this outcome have not been posted.
The perceived level of physical functioning is assessed by the Activities Scale for Kids
Results for this outcome have not been posted.
Evaluation of standing long jump by the Adapted Functional Strength measure.
| distance in centimer | Intervention Group | Waitlist-control Group |
|---|---|---|
| Change in Functional Muscle Strength - Maximum Jumping Distance | 5.8 (-0.2 to 11.8) | 2.7 (-2.8 to 8.3) |
Evaluation of walking capacity by assessing the distance covered during the 1-minute walking test
| distance in meters | Intervention Group | Waitlist-control Group |
|---|---|---|
| Change in Walking Capacity | 5.6 (0.9 to 10.4) | 3.6 (-1.0 to 8.1) |
Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Group | 0/26 (0%) | 0/26 (0%) | 10/26 (38.5%) |
| Waitlist-control Group | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Event | Intervention Group | Waitlist-control Group |
|---|---|---|
| muscle cramp or pain, joint pain and general discomfort from the weighted vestMusculoskeletal and connective tissue disorders | 10/26 | 0/22 |
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.
| Age, Categorical(Participants) | Intervention Group | Waitlist-control Group | Total |
|---|---|---|---|
| <=18 years | 26 | 22 | 48 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Intervention Group | Waitlist-control Group | Total |
|---|---|---|---|
| Mean | 8.3 ± 2.0 | 8.5 ± 2.1 | 8.4 ± 2.0 |
| Sex: Female, Male(Participants) | Intervention Group | Waitlist-control Group | Total |
|---|---|---|---|
| Female | 12 | 6 | 18 |
| Male | 14 | 16 | 30 |
| Race and Ethnicity Not Collected(Participants) | Intervention Group | Waitlist-control Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Intervention Group | Waitlist-control Group | Total |
|---|---|---|---|
| Belgium | 26 | 22 | 48 |
| Involvement(Participants) | Intervention Group | Waitlist-control Group | Total |
|---|---|---|---|
| Unilateral | 11 | 8 | 19 |
| Bilateral | 15 | 14 | 29 |
| Gross motor function classification system(Participants) | Intervention Group | Waitlist-control Group | Total |
|---|---|---|---|
| Level I | 17 | 14 | 31 |
| Level II | 5 | 5 | 10 |
| Level III | 4 | 3 | 7 |
| Weight(kilogram) | Intervention Group | Waitlist-control Group | Total |
|---|---|---|---|
| Mean | 27.7 ± 8.1 | 28.3 ± 7.1 | 28.0 ± 7.6 |
3 further baseline measures are reported on the registry.
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Universitaire Ziekenhuizen KU Leuven