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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03863197

Enrollment

Registered

2019-03-05

Start date

2018-08-01

Completion date

2021-06-01

Last updated

2025-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy, Spastic

Keywords

Cerebral Palsy, Spastic Cerebral Palsy, Progressive Strength Training, Muscle morphology

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.

Interventions

BEHAVIORALProgressive strength training

Progressive Supervised Home-based Strength Training

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Intervention model description

Randomized controlled trial with waitlist control group

Eligibility

Sex/Gender

ALL

Age

5 Years to 11 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
Change in Functional Muscle Strength - Maximum Jumping Distance	baseline, post-intervention (12-weeks)	Evaluation of standing long jump by the Adapted Functional Strength measure.
Change in Muscle Size Parameter	baseline, post-intervention (12-weeks)	Estimation of muscle volume by 3D freehand ultrasonography.
Change in Muscle Length	baseline, post-intervention (12-weeks)	Estimation of muscle length parameters by 3D freehand ultrasonography from origo to muscle tendon junction.
Change in Echogenicity Intensity	baseline, post-intervention (12-weeks)	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.
Change in Isometric Muscle Strength	baseline, post-intervention (12-weeks)	Evaluation of isometric muscle strength by Instrumented Weakness Assessment.
Change in Functional Muscle Strength - Muscle Endurance	baseline, post-intervention (12-weeks)	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.

Secondary

Measure	Time frame	Description
Change in Gross Motor Function	baseline, post-intervention (12 weeks)	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.
Change in Walking Capacity	baseline, post-intervention (12 weeks)	Evaluation of walking capacity by assessing the distance covered during the 1-minute walking test

Other

Measure	Time frame	Description
Change in Functionality	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).
Change in Patient Reported Physical Function	Baseline, post-intervention (12 weeks)	The perceived level of physical functioning is assessed by the Activities Scale for Kids
Change in Quality of Life	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.

Countries

Belgium

Participant flow

Recruitment details

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).

Participants by arm

Arm	Count
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	26
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	41
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.	22
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.	36
Total	125

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Did not receive intervention (inability to cooperate with assessment or cancellation due to Covid)	2	0
Overall Study	Lost to Follow-up	2	3
Overall Study	Withdrawal by Subject	4	0

Baseline characteristics

Characteristic	Intervention Group	Waitlist-control Group	Total
Age, Categorical <=18 years	26 Participants	22 Participants	48 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants	0 Participants
Age, Continuous	8.3 years STANDARD_DEVIATION 2	8.5 years STANDARD_DEVIATION 2.1	8.4 years STANDARD_DEVIATION 2
Fibula length	27.7 millimeter STANDARD_DEVIATION 3.6	27.8 millimeter STANDARD_DEVIATION 3.5	27.7 millimeter STANDARD_DEVIATION 3.5
Gross motor function classification system Level I	17 Participants	14 Participants	31 Participants
Gross motor function classification system Level II	5 Participants	5 Participants	10 Participants
Gross motor function classification system Level III	4 Participants	3 Participants	7 Participants
Height	127.3 centimeter STANDARD_DEVIATION 14	128.6 centimeter STANDARD_DEVIATION 11.2	127.9 centimeter STANDARD_DEVIATION 12.7
Involvement Bilateral	15 Participants	14 Participants	29 Participants
Involvement Unilateral	11 Participants	8 Participants	19 Participants
Race and Ethnicity Not Collected	—	—	0 Participants
Region of Enrollment Belgium	26 participants	22 participants	48 participants
Selective control assessment of the lower extremity (score out of 10)	7.0 units on a scale STANDARD_DEVIATION 2.1	7.1 units on a scale STANDARD_DEVIATION 2.6	7.0 units on a scale STANDARD_DEVIATION 2.2
Sex: Female, Male Female	12 Participants	6 Participants	18 Participants
Sex: Female, Male Male	14 Participants	16 Participants	30 Participants
Weight	27.7 kilogram STANDARD_DEVIATION 8.1	28.3 kilogram STANDARD_DEVIATION 7.1	28.0 kilogram STANDARD_DEVIATION 7.6

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 26	0 / 22
other Total, other adverse events	10 / 26	0 / 22
serious Total, serious adverse events	0 / 26	0 / 22

Outcome results

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.

Time frame: baseline, post-intervention (12-weeks)

Population: 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.

Arm	Measure	Group	Value (MEAN)
Intervention Group	Change in Echogenicity Intensity	Echo-intensity - rectus femoris	-0.3 arbitrary units
Intervention Group	Change in Echogenicity Intensity	Echo-intensity - semitendinosus	3.8 arbitrary units
Intervention Group	Change in Echogenicity Intensity	Echo-intensity - medial gastrocnemius	0.2 arbitrary units
Waitlist-control Group	Change in Echogenicity Intensity	Echo-intensity - rectus femoris	-0.1 arbitrary units
Waitlist-control Group	Change in Echogenicity Intensity	Echo-intensity - semitendinosus	3.2 arbitrary units
Waitlist-control Group	Change in Echogenicity Intensity	Echo-intensity - medial gastrocnemius	1.8 arbitrary units