Trial Outcomes & Findings for Progressive Supervised Home-based Strength Training in Children With Spastic Cerebral Palsy (NCT NCT03863197)
NCT ID: NCT03863197
Last Updated: 2025-07-08
Results Overview
Estimation of muscle volume by 3D freehand ultrasonography.
COMPLETED
NA
49 participants
baseline, post-intervention (12-weeks)
2025-07-08
Participant Flow
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).
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
22
|
|
Overall Study
COMPLETED
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
8
|
3
|
Reasons for withdrawal
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
|
Overall Study
Did not receive intervention (inability to cooperate with assessment or cancellation due to Covid)
|
2
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intervention Group
n=41 Legs
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
|
Waitlist-control Group
n=36 Legs
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.
|
Total
n=77 Legs
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
26 Participants
n=26 Participants
|
22 Participants
n=22 Participants
|
48 Participants
n=48 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=26 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=48 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=26 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=48 Participants
|
|
Age, Continuous
|
8.3 years
STANDARD_DEVIATION 2.0 • n=26 Participants
|
8.5 years
STANDARD_DEVIATION 2.1 • n=22 Participants
|
8.4 years
STANDARD_DEVIATION 2.0 • n=48 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=26 Participants
|
6 Participants
n=22 Participants
|
18 Participants
n=48 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=26 Participants
|
16 Participants
n=22 Participants
|
30 Participants
n=48 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Belgium
|
26 participants
n=26 Participants
|
22 participants
n=22 Participants
|
48 participants
n=48 Participants
|
|
Involvement
Unilateral
|
11 Participants
n=26 Participants
|
8 Participants
n=22 Participants
|
19 Participants
n=48 Participants
|
|
Involvement
Bilateral
|
15 Participants
n=26 Participants
|
14 Participants
n=22 Participants
|
29 Participants
n=48 Participants
|
|
Gross motor function classification system
Level I
|
17 Participants
n=26 Participants
|
14 Participants
n=22 Participants
|
31 Participants
n=48 Participants
|
|
Gross motor function classification system
Level II
|
5 Participants
n=26 Participants
|
5 Participants
n=22 Participants
|
10 Participants
n=48 Participants
|
|
Gross motor function classification system
Level III
|
4 Participants
n=26 Participants
|
3 Participants
n=22 Participants
|
7 Participants
n=48 Participants
|
|
Weight
|
27.7 kilogram
STANDARD_DEVIATION 8.1 • n=26 Participants
|
28.3 kilogram
STANDARD_DEVIATION 7.1 • n=22 Participants
|
28.0 kilogram
STANDARD_DEVIATION 7.6 • n=48 Participants
|
|
Height
|
127.3 centimeter
STANDARD_DEVIATION 14.0 • n=26 Participants
|
128.6 centimeter
STANDARD_DEVIATION 11.2 • n=22 Participants
|
127.9 centimeter
STANDARD_DEVIATION 12.7 • n=48 Participants
|
|
Fibula length
|
27.7 millimeter
STANDARD_DEVIATION 3.6 • n=41 Legs
|
27.8 millimeter
STANDARD_DEVIATION 3.5 • n=36 Legs
|
27.7 millimeter
STANDARD_DEVIATION 3.5 • n=77 Legs
|
|
Selective control assessment of the lower extremity (score out of 10)
|
7.0 units on a scale
STANDARD_DEVIATION 2.1 • n=41 Legs
|
7.1 units on a scale
STANDARD_DEVIATION 2.6 • n=36 Legs
|
7.0 units on a scale
STANDARD_DEVIATION 2.2 • n=77 Legs
|
PRIMARY outcome
Timeframe: 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.
Estimation of muscle volume by 3D freehand ultrasonography.
Outcome measures
| Measure |
Intervention Group
n=41 Affected legs
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
|
Waitlist-control Group
n=36 Affected legs
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.
|
|---|---|---|
|
Change in Muscle Size Parameter
Muscle volume - rectus femoris
|
3.7 milliliters
Interval 1.9 to 5.5
|
1.6 milliliters
Interval -0.1 to 3.4
|
|
Change in Muscle Size Parameter
Muscle volume - semitendinosis
|
1.4 milliliters
Interval -0.5 to 3.3
|
0.1 milliliters
Interval -1.8 to 2.0
|
|
Change in Muscle Size Parameter
Muscle volume - medial gastrocnemius
|
2.0 milliliters
Interval 0.9 to 3.1
|
0.5 milliliters
Interval -0.5 to 1.6
|
PRIMARY outcome
Timeframe: 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.
Estimation of muscle length parameters by 3D freehand ultrasonography from origo to muscle tendon junction.
Outcome measures
| Measure |
Intervention Group
n=41 Affected legs
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
|
Waitlist-control Group
n=36 Affected legs
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.
|
|---|---|---|
|
Change in Muscle Length
Muscle length - rectus femoris
|
3.9 millimeters
Interval 0.0 to 7.7
|
5.5 millimeters
Interval 1.8 to 9.3
|
|
Change in Muscle Length
Muscle length - semitendinosis
|
3.2 millimeters
Interval -1.3 to 7.7
|
3.0 millimeters
Interval -1.6 to 7.5
|
|
Change in Muscle Length
Muscle length - medial gastrocnemius
|
3.5 millimeters
Interval 1.4 to 5.6
|
2.4 millimeters
Interval 0.3 to 4.4
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Intervention Group
n=41 legs
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
|
Waitlist-control Group
n=36 legs
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.
|
|---|---|---|
|
Change in Echogenicity Intensity
Echo-intensity - rectus femoris
|
-0.3 arbitrary units
Interval -4.6 to 3.9
|
-0.1 arbitrary units
Interval -4.2 to 4.1
|
|
Change in Echogenicity Intensity
Echo-intensity - semitendinosus
|
3.8 arbitrary units
Interval -1.1 to 8.7
|
3.2 arbitrary units
Interval -1.9 to 8.3
|
|
Change in Echogenicity Intensity
Echo-intensity - medial gastrocnemius
|
0.2 arbitrary units
Interval -3.0 to 2.4
|
1.8 arbitrary units
Interval -1.4 to 4.9
|
PRIMARY outcome
Timeframe: 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.
Evaluation of isometric muscle strength by Instrumented Weakness Assessment.
Outcome measures
| Measure |
Intervention Group
n=41 legs
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
|
Waitlist-control Group
n=36 legs
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.
|
|---|---|---|
|
Change in Isometric Muscle Strength
Plantar flexion strength
|
3.6 Newton meters
Interval 2.2 to 5.0
|
1.1 Newton meters
Interval -0.3 to 2.5
|
|
Change in Isometric Muscle Strength
Knee extension strength
|
2.5 Newton meters
Interval 0.8 to 4.2
|
-0.4 Newton meters
Interval -2.1 to 1.2
|
|
Change in Isometric Muscle Strength
Knee flexion strength
|
6.0 Newton meters
Interval 3.3 to 8.7
|
0.8 Newton meters
Interval -1.9 to 3.4
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Intervention Group
n=41 legs
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
|
Waitlist-control Group
n=36 legs
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.
|
|---|---|---|
|
Change in Functional Muscle Strength - Muscle Endurance
Sit-to-stand
|
2.7 repetitions
Interval 1.2 to 4.1
|
0.3 repetitions
Interval -1.3 to 1.9
|
|
Change in Functional Muscle Strength - Muscle Endurance
Lateral step-up
|
2.7 repetitions
Interval 1.4 to 3.9
|
1.1 repetitions
Interval -0.2 to 2.3
|
|
Change in Functional Muscle Strength - Muscle Endurance
Bilateral heel raise
|
4.5 repetitions
Interval 1.9 to 7.1
|
3.6 repetitions
Interval 1.1 to 6.0
|
|
Change in Functional Muscle Strength - Muscle Endurance
Unilateral heel raise
|
9.1 repetitions
Interval 5.7 to 12.4
|
-1.5 repetitions
Interval -4.7 to 1.7
|
PRIMARY outcome
Timeframe: 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.
Evaluation of standing long jump by the Adapted Functional Strength measure.
Outcome measures
| Measure |
Intervention Group
n=19 Participants
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
|
Waitlist-control Group
n=16 Participants
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.
|
|---|---|---|
|
Change in Functional Muscle Strength - Maximum Jumping Distance
|
5.8 distance in centimer
Interval -0.2 to 11.8
|
2.7 distance in centimer
Interval -2.8 to 8.3
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Intervention Group
n=26 Participants
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
|
Waitlist-control Group
n=21 Participants
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.
|
|---|---|---|
|
Change in Gross Motor Function
|
0.7 score on a scale
Interval -0.6 to 2.1
|
0.3 score on a scale
Interval -1.1 to 1.8
|
SECONDARY outcome
Timeframe: 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.
Evaluation of walking capacity by assessing the distance covered during the 1-minute walking test
Outcome measures
| Measure |
Intervention Group
n=22 Participants
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
|
Waitlist-control Group
n=21 Participants
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.
|
|---|---|---|
|
Change in Walking Capacity
|
5.6 distance in meters
Interval 0.9 to 10.4
|
3.6 distance in meters
Interval -1.0 to 8.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, post-intervention (12 weeks)The perceived level of physical functioning is assessed by the Activities Scale for Kids
Outcome measures
Outcome data not reported
Adverse Events
Intervention Group
Waitlist-control Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention Group
n=26 participants at risk
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
|
Waitlist-control Group
n=22 participants at risk
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
muscle cramp or pain, joint pain and general discomfort from the weighted vest
|
38.5%
10/26 • Number of events 10 • 12 weeks
|
0.00%
0/22 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place