Spastic Cerebral Palsy
Conditions
Keywords
Cerebral Palsy, Spastic Cerebral Palsy, Botulinum Toxin, muscle morphology, Range of motion, Stiffness, Spasticity, Intensive physical therapy
Brief summary
This study investigates the effect of integrated Botulinum Neurotoxin A (BoNT) treatment on morphologic muscle and tendon properties, spasticity, joint stiffness, joint range of motion, muscle strength, gait and gross motor function. The integrated BoNT treatment combines BoNT-injections with serial casting and intensive physical therapy, as previously described by Molenaers et al. The current study will include 30 children who are clinically scheduled for BoNT treatment in the medial gastrocnemius and/or the semitendinosus muscle in the intervention group and 30 children in a control group who will receive usual care within a time span of 3 months.
Detailed description
Aim: This study investigates the effect of integrated Botulinum Neurotoxin A (BoNT) treatment on morphologic muscle and tendon properties (muscle length and muscle volume, assessed with a 3D ultrasound measurement), spasticity and joint stiffness (measured with an instrumented spasticity assessment), joint range of motion (measured through goniometry), muscle strength (measured using dynamometry), gait (assessed through 3D gait analysis) and gross motor function (assessed using clinical test batteries). The aim is twofold: (1) determine whether integrated BoNT treatment of the medial gastrocnemius and the semitendinosus muscle(s) leads to changes in the morphologic muscle and tendon properties of the medial gastrocnemius and the semitendinosus muscle(s), the ankle and knee range of motion, spasticity, stiffness, muscle strength and gait, and (2) determine the correlation between baseline morphologic muscle and tendon properties and the changes in the primary outcome parameters (spasticity and stiffness) following the BoNT-treatment. Design: The current study has a non-randomized controlled design. Because BoNT is proven an effective treatment to reduce spasticity and improve gross motor function, it cannot be clinically justified to allocate children to a non-treatment group, if a new BoNT treatment is required. Delayed BoNT treatment could rapidly increase musculoskeletal impairments. It is therefore considered unethical to temporarily withdraw BoNT treatment from patients. To compensate the lack of randomization accurate matching of groups is required. Children will be matched on diagnosis (uni/bilateral CP), GMFCS level, age and spasticity level. BoNT-treatment: All children in the intervention group will receive BoNT injections in the medial gastrocnemius and/or the semitendinosus muscle(s) (other muscles may also be treated as part of multilevel treatment). As part of the standard integrated treatment approach of the CP Reference Centre of the University Hospitals Leuven, the injections are followed by a period of bilateral stretching casts if indicated (below the knee walking casts and removable knee extension casts when necessary) and all children will receive intensive physical therapy and application of orthotic management following BoNT injections. The follow-up period for the current study is 8-10 weeks. During this intensive physical therapy post-BoNT, the children in the intervention group will work on individualized treatment goals. These goals will be defined based on the baseline measurements during a multidisciplinary discussion with the treating physician, which is scheduled prior to the BoNT treatment. The fulfillment of these patient-specific goals will be evaluated by the Goal Attainment Score (GAS). During the follow-up period, the treating physical therapist will be interviewed on a two-weekly basis to verify whether and to what extend the therapy is focused on the personal treatment goals. Assessments of morphologic muscle and tendon properties, spasticity, stiffness, joint range of motion, muscle strength, and gait of the participants will be performed before the BoNT injections, and 8-10 weeks after the injection. This period of 8-10 weeks follow-up post BoNT injections was found to be appropriate, since the potential effect of BoNT on gross motor function is expected to be optimal after 6-10 weeks. Study groups: The study will include patients who are diagnosed with spastic CP, aged between 4 and 11 years and with Gross Motor Function Classification System (GMFCS) level I-III. The intervention and control group will be group-matched based on diagnosis (uni/lateral CP), GMFCS level, age and spasticity level. Overall exclusion criteria were: BoNT injections less than 6 months before inclusion, a treatment history that includes previous selective dorsal rhizotomy treatment or a bony surgery less than 2 years before inclusion, and limited cooperation that would prevent a proper assessment. For all enrolled children, intensive rehabilitation post BoNT injections had to be foreseen as the standard care. For the intervention group, 30 children with a clinical indication for BoNT injections in the medial gastrocnemius and/or semitendinosus muscle(s) will be recruited, while for the control group, 30 children without an indication for a specific intervention in the next 3 months will be recruited. For the intervention group, the baseline measures will be followed by the BoNT injections combined with casting and goal-oriented physical therapy (as described above), and the follow-up assessments will be planned 8-10 weeks post BoNT injections. Baseline and follow-up assessments for the intervention groups include 3D ultrasound, the instrumented spasticity measurement, functional strength tests, and 3D gait analysis. The children in the control group will also be assessed twice with an interval of 8-10 weeks. During the 8-10 weeks, they will continue their usual care or normal routine treatment, i.e. regular physiotherapy and orthotic devices. Baseline and follow-up assessments for the control group include 3D ultrasound, the instrumented spasticity measurement and functional strength tests.
Interventions
OTHERBotulinum Toxin treatment combined with a post-BoNT intensive physical therapy period guided by individualized treatment goals.
BoNT treatment combined with a follow-up period of intensive physical therapy of 8-10 weeks. During this intensive physical therapy post BoNT injections, the children in the intervention group will work on individualized treatment goals, which will be defined based on the baseline measurements during a multidisciplinary discussion with the treating physician (planned prior to the BoNT injections).
Sponsors
KU Leuven
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
We will include patients who receive BoNT injections at the lower limb in the intervention group. Patient with no indication for treatment in the next three months (besides the routine physical therapy and orthotic management) will be asked to participate in the control group. Justification for the non-randomized design is stated above.
Eligibility
Sex/Gender
ALL
Age
4 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of spastic cerebral palsy * Aged 4-11 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 * Additional exclusion criterion for the intervention group specifically: Indication for BoNT injections
Exclusion criteria
* Non-ambulatory * Botulinum toxin A injections six months prior to enrollment * Lower limb surgery two years prior to enrollment * Previous selective dorsal rhizotomy * 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) * Hospitalization after the BoNT treatment for intensive physical therapy * Intrathecal baclofen pump * For the control group: new intervention planned within 3 months * Additional exclusion criterion for the control group specifically: new intervention planned within 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Spasticity of the Medial Gastrocnemius and the Medial Hamstrings | Between baseline and 8-10 weeks after the BoNT injections | Muscle activity of the medial gastrocnemius and the medial hamstrings as recorded by surface electromyography (millivolts) during a passive stretch at high velocity of the plantar flexors and the hamstrings. |
| Change in Normalized Muscle Volume of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus | Between baseline and 8-10 weeks after the BoNT injections for the intervention group, and between baseline and 8-10 weeks later for the control group. | Estimation of the muscle belly volume by three-dimensional freehand ultrasonography normalized to the product of body weight and height |
| Change in Echogenicity Intensity of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus | Between baseline and 8-10 weeks after the BoNT injections for the intervention group, and between baseline and 8-10 weeks later for the control group. | Estimation of the echogenicity intensity of the whole muscle volume by three-dimensional freehand ultrasonography. Echogenicity is expressed in arbitrary units ranging from 0 to 255. Higher values indicate lighter images, which indirectly suggests the presence of more non-contractile muscle tissue. |
| Absolute Muscle Volume Growth Rate of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus | Between baseline and 8-10 weeks after the BoNT injections for the intervention group, and between baseline and 8-10 weeks later for the control group. | Estimation of the absolute muscle volume growth rate, calculated by: (muscle volume (mL)post-muscle volume pre)/(age (months)post-age (months)pre) |
| Change in Kinematic Parameters | Between baseline and 8-10 weeks after the BoNT injections | Estimation of the kinematic parameters throughout the whole gait cycle by three-dimensional gait analysis. |
| Change in Gait Profile Score (Degrees) | Between baseline and 8-10 weeks after the BoNT injections | The Gait Profile Score (GPS) is a summary measure derived from three-dimensional gait analysis that quantifies the overall deviation of a patient's gait kinematics from a normative (typically developing) reference dataset. It is calculated as the root mean square difference between the patient's joint angle trajectories of the lower limb and the corresponding mean trajectories of typically developing individuals across a gait cycle. The GPS is expressed in degrees and is based on nine key kinematic variables: pelvic tilt, obliquity, rotation; hip flexion, abduction, rotation; knee flexion; ankle dorsiflexion; and foot progression angle, typically for both left and right sides. It provides a global index of gait abnormality, where lower scores indicate gait patterns closer to normal, and higher scores reflect greater kinematic deviation. |
| Change in the Spatial-temporal Parameter Cadence. | Between baseline and 8-10 weeks after the BoNT injections | Estimation of the cadence by three-dimensional gait analysis. |
| Change in the Spatial-temporal Parameter Walking Velocity. | Between baseline and 8-10 weeks after the BoNT injections | Estimation of the walking velocity by three-dimensional gait analysis. |
| Change in the Spatial-temporal Parameter Stride Length. | Between baseline and 8-10 weeks after the BoNT injections | Estimation of the stride length by three-dimensional gait analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Normalized Muscle Belly Length of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus | Between baseline and 8-10 weeks after the BoNT injections for the intervention group, and between baseline and 8-10 weeks later for the control group. | Estimation of the muscle belly length by three-dimensional freehand ultrasonography, expressed as a percentage of total leg length. |
| Change in Normalized Tendon Length of the Medial Gastrocnemius | Between baseline and 8-10 weeks after the BoNT injections for the intervention group, and between baseline and 8-10 weeks later for the control group. | Estimation of the tendon length by three-dimensional freehand ultrasonography, expressed as a percentage of total leg length. |
| Normalized Muscle Volume Growth Rates of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus | Between baseline and 8-10 weeks after the BoNT injections for the intervention group, and between baseline and 8-10 weeks later for the control group. | Estimation of the normalized muscle volume growth rates, calculated by (Normalized muscle volume (mL/kg\*m)post-Normalized muscle volume pre (mL/kg\*m))/(age (months)post-age (months)pre) |
| Change in the Kinematic Parameter Ankle Range of Motion in Sagittal Plane During Stance Phase | Between baseline and 8-10 weeks after the BoNT injections | Estimation of ankle range of motion in sagittal plane during stance phase by three-dimensional gait analysis. |
| Change in the Kinematic Parameter Knee Range of Motion in Sagittal Plane During Stance Phase | Between baseline and 8-10 weeks after the BoNT injections | Estimation of knee range of motion in sagittal plane during stance phase by three-dimensional gait analysis. |
| Change in Muscle Activation of the Medial Gastrocnemius and the Medial Hamstrings (i.e. the Change During the High-velocity Stretch). | Between baseline and 8-10 weeks after the BoNT injections | Calculated by subtracting the muscle activation during a low-velocity stretch. Muscle activity of the medial gastrocnemius and Medial Hamstrings is recorded by surface electromyography (millivolts) during a passive stretch of the plantar flexors and of the hamstrings. |
| Change of Range of Motion in the Ankle and Knee Joint | Between baseline and 8-10 weeks after the BoNT injections | Evaluation by goniometry expressed in degrees. For the ankle plantar flexion range of motion with the knee extended, for the hamstrings unilateral popliteal angle. |
| Change in Normalized Muscle Tendon Unit Length of the Medial Gastrocnemius | Between baseline and 8-10 weeks after the BoNT injections for the intervention group, and between baseline and 8-10 weeks later for the control group. | Estimation of the muscle tendon unit length by three-dimensional freehand ultrasonography, expressed as a percentage of total leg length. |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group The children in the intervention group will receive BoNT injections in the medial gastrocnemius and/or the semitendinosus muscle(s). As part of the standard treatment approach of the CP Reference Centre of the University Hospitals Leuven, the injections are followed by a period of bilateral stretching casts if indicated (below the knee walking casts and removable knee extension casts when necessary).
All children will then undergo an intensive physical therapy program lasting 8-10 weeks. This post-BoNT therapy phase is guided by individualized treatment goals, which are established based on baseline assessments. These goals are determined during a multidisciplinary meeting with the treating physician, held prior to the BoNT injections.
Thus, the intervention consists of BoNT treatment combined with an 8-10 week period of intensive physical therapy tailored to each child's specific therapeutic needs. | 25 |
| Control Group This group will continue their usual care or normal routine treatment, i.e. physiotherapy and orthotic management during a period of 8-10 weeks. | 20 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Pre-BoNT/ Pre-3DfUS | Bad 3DGA data | 2 | 0 |
| Pre-BoNT/ Pre-3DfUS | Insufficient matching | 0 | 10 |
| Pre-BoNT/ Pre-3DfUS | No 3DGA | 4 | 0 |
Baseline characteristics
| Characteristic | Control Group | Total | Intervention Group |
|---|---|---|---|
| Age, Categorical <=18 years | 20 Participants | 45 Participants | 25 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 | 7.6 Years | 7.1 Years | 6.4 Years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Belgium | 20 participants | 45 participants | 25 participants |
| Sex: Female, Male Female | 4 Participants | 16 Participants | 12 Participants |
| Sex: Female, Male Male | 16 Participants | 29 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 20 |
| other Total, other adverse events | 0 / 25 | 0 / 20 |
| serious Total, serious adverse events | 0 / 25 | 0 / 20 |
Outcome results
Primary
Absolute Muscle Volume Growth Rate of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus
Estimation of the absolute muscle volume growth rate, calculated by: (muscle volume (mL)post-muscle volume pre)/(age (months)post-age (months)pre)
Time frame: Between baseline and 8-10 weeks after the BoNT injections for the intervention group, and between baseline and 8-10 weeks later for the control group.
Population: Semitendinosus:~Intervention group: n = 24 \< 25 due to bad quality data Control group: n = 19 \< 20 due to bad quality data
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention Group | Absolute Muscle Volume Growth Rate of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus | Medial Gastrocnemius | 0.00 ml/month |
| Intervention Group | Absolute Muscle Volume Growth Rate of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus | Semitendinosus | -0.49 ml/month |
| Control Group | Absolute Muscle Volume Growth Rate of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus | Medial Gastrocnemius | 0.17 ml/month |
| Control Group | Absolute Muscle Volume Growth Rate of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus | Semitendinosus | 0.02 ml/month |
Primary
Change in Echogenicity Intensity of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus
Estimation of the echogenicity intensity of the whole muscle volume by three-dimensional freehand ultrasonography. Echogenicity is expressed in arbitrary units ranging from 0 to 255. Higher values indicate lighter images, which indirectly suggests the presence of more non-contractile muscle tissue.
Time frame: Between baseline and 8-10 weeks after the BoNT injections for the intervention group, and between baseline and 8-10 weeks later for the control group.
Population: Semitendinosus:~Intervention group: n = 24 \< 25 due to bad quality data Control group: n = 19 \< 20 due to bad quality data
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention Group | Change in Echogenicity Intensity of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus | Medial Gastrocnemius | 2.74 Arbitrary units ranging from 0 to 255 |
| Intervention Group | Change in Echogenicity Intensity of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus | Semitendinosus | 6.58 Arbitrary units ranging from 0 to 255 |
| Control Group | Change in Echogenicity Intensity of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus | Medial Gastrocnemius | -0.08 Arbitrary units ranging from 0 to 255 |
| Control Group | Change in Echogenicity Intensity of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus | Semitendinosus | 5.20 Arbitrary units ranging from 0 to 255 |
Primary
Change in Gait Profile Score (Degrees)
The Gait Profile Score (GPS) is a summary measure derived from three-dimensional gait analysis that quantifies the overall deviation of a patient's gait kinematics from a normative (typically developing) reference dataset. It is calculated as the root mean square difference between the patient's joint angle trajectories of the lower limb and the corresponding mean trajectories of typically developing individuals across a gait cycle. The GPS is expressed in degrees and is based on nine key kinematic variables: pelvic tilt, obliquity, rotation; hip flexion, abduction, rotation; knee flexion; ankle dorsiflexion; and foot progression angle, typically for both left and right sides. It provides a global index of gait abnormality, where lower scores indicate gait patterns closer to normal, and higher scores reflect greater kinematic deviation.
Time frame: Between baseline and 8-10 weeks after the BoNT injections
Population: Control group: 3DGA was not performed
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Group | Change in Gait Profile Score (Degrees) | -1.76 Degrees |
Primary
Change in Kinematic Parameters
Estimation of the kinematic parameters throughout the whole gait cycle by three-dimensional gait analysis.
Time frame: Between baseline and 8-10 weeks after the BoNT injections
Population: Control group: 3DGA was not performed
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention Group | Change in Kinematic Parameters | Knee Range of Motion in Sagittal Plane | 1.94 Degrees |
| Intervention Group | Change in Kinematic Parameters | Ankle Range of Motion in Sagittal Plane | -1.74 Degrees |
| Intervention Group | Change in Kinematic Parameters | Ankle Angle in Sagittal Plane at Initial Contact | 3.56 Degrees |
| Intervention Group | Change in Kinematic Parameters | Maximal Ankle Angle in Sagittal Plane During Stance Phase | 3.99 Degrees |
| Intervention Group | Change in Kinematic Parameters | Maximal Ankle Angle in Sagittal Plane During Swing Phase | 5.34 Degrees |
| Intervention Group | Change in Kinematic Parameters | Knee Angle in Sagittal Plane at Initial Contact | -1.69 Degrees |
| Intervention Group | Change in Kinematic Parameters | Minimal Knee Angle in Sagittal Plane During Stance | -2.44 Degrees |
Primary
Change in Normalized Muscle Volume of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus
Estimation of the muscle belly volume by three-dimensional freehand ultrasonography normalized to the product of body weight and height
Time frame: Between baseline and 8-10 weeks after the BoNT injections for the intervention group, and between baseline and 8-10 weeks later for the control group.
Population: Semitendinosus:~Intervention group: n = 24 \< 25 due to bad quality data Control group: n = 19 \< 20 due to bad quality data
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention Group | Change in Normalized Muscle Volume of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus | Medial Gastrocnemius | -0.08 ml/kg*m |
| Intervention Group | Change in Normalized Muscle Volume of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus | Semitendinosus | -0.09 ml/kg*m |
| Control Group | Change in Normalized Muscle Volume of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus | Medial Gastrocnemius | 0.00 ml/kg*m |
| Control Group | Change in Normalized Muscle Volume of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus | Semitendinosus | -0.01 ml/kg*m |
Primary
Change in Spasticity of the Medial Gastrocnemius and the Medial Hamstrings
Muscle activity of the medial gastrocnemius and the medial hamstrings as recorded by surface electromyography (millivolts) during a passive stretch at high velocity of the plantar flexors and the hamstrings.
Time frame: Between baseline and 8-10 weeks after the BoNT injections
Population: Control group: ISA was not performed n (medial hamstrings) = 13 \< 14 due to insufficient cooperation
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention Group | Change in Spasticity of the Medial Gastrocnemius and the Medial Hamstrings | Medial Gastrocnemius | -4.73 µV |
| Intervention Group | Change in Spasticity of the Medial Gastrocnemius and the Medial Hamstrings | Medial Hamstrings | -2.82 µV |
Primary
Change in the Spatial-temporal Parameter Cadence.
Estimation of the cadence by three-dimensional gait analysis.
Time frame: Between baseline and 8-10 weeks after the BoNT injections
Population: Control group: 3DGA was not performed
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Group | Change in the Spatial-temporal Parameter Cadence. | -0.05 Number of steps/second |
Primary
Change in the Spatial-temporal Parameter Stride Length.
Estimation of the stride length by three-dimensional gait analysis.
Time frame: Between baseline and 8-10 weeks after the BoNT injections
Population: Control group: 3DGA was not performed
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Group | Change in the Spatial-temporal Parameter Stride Length. | 0.02 Meters |
Primary
Change in the Spatial-temporal Parameter Walking Velocity.
Estimation of the walking velocity by three-dimensional gait analysis.
Time frame: Between baseline and 8-10 weeks after the BoNT injections
Population: Control group: 3DGA was not performed
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Group | Change in the Spatial-temporal Parameter Walking Velocity. | 0.01 Meter/second |
Secondary
Change in Muscle Activation of the Medial Gastrocnemius and the Medial Hamstrings (i.e. the Change During the High-velocity Stretch).
Calculated by subtracting the muscle activation during a low-velocity stretch. Muscle activity of the medial gastrocnemius and Medial Hamstrings is recorded by surface electromyography (millivolts) during a passive stretch of the plantar flexors and of the hamstrings.
Time frame: Between baseline and 8-10 weeks after the BoNT injections
Population: Control group: ISA was not performed n (medial hamstrings) = 13 \< 14 due to insufficient cooperation
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention Group | Change in Muscle Activation of the Medial Gastrocnemius and the Medial Hamstrings (i.e. the Change During the High-velocity Stretch). | Medial Gastrocnemius | -2.64 µV |
| Intervention Group | Change in Muscle Activation of the Medial Gastrocnemius and the Medial Hamstrings (i.e. the Change During the High-velocity Stretch). | Medial Hamstrings | -3.13 µV |
Secondary
Change in Normalized Muscle Belly Length of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus
Estimation of the muscle belly length by three-dimensional freehand ultrasonography, expressed as a percentage of total leg length.
Time frame: Between baseline and 8-10 weeks after the BoNT injections for the intervention group, and between baseline and 8-10 weeks later for the control group.
Population: Semitendinosus:~Intervention group: n = 24 \< 25 due to bad quality data Control group: n = 19 \< 20 due to bad quality data
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention Group | Change in Normalized Muscle Belly Length of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus | Medial Gastrocnemius | 0.44 a percentage of total leg length |
| Intervention Group | Change in Normalized Muscle Belly Length of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus | Semitendinosus | -0.32 a percentage of total leg length |
| Control Group | Change in Normalized Muscle Belly Length of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus | Medial Gastrocnemius | -0.13 a percentage of total leg length |
| Control Group | Change in Normalized Muscle Belly Length of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus | Semitendinosus | -0.22 a percentage of total leg length |
Secondary
Change in Normalized Muscle Tendon Unit Length of the Medial Gastrocnemius
Estimation of the muscle tendon unit length by three-dimensional freehand ultrasonography, expressed as a percentage of total leg length.
Time frame: Between baseline and 8-10 weeks after the BoNT injections for the intervention group, and between baseline and 8-10 weeks later for the control group.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Group | Change in Normalized Muscle Tendon Unit Length of the Medial Gastrocnemius | 0.88 a percentage of total leg length |
| Control Group | Change in Normalized Muscle Tendon Unit Length of the Medial Gastrocnemius | -0.35 a percentage of total leg length |
Secondary
Change in Normalized Tendon Length of the Medial Gastrocnemius
Estimation of the tendon length by three-dimensional freehand ultrasonography, expressed as a percentage of total leg length.
Time frame: Between baseline and 8-10 weeks after the BoNT injections for the intervention group, and between baseline and 8-10 weeks later for the control group.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Group | Change in Normalized Tendon Length of the Medial Gastrocnemius | -0.03 a percentage of total leg length |
| Control Group | Change in Normalized Tendon Length of the Medial Gastrocnemius | -0.26 a percentage of total leg length |
Secondary
Change in the Kinematic Parameter Ankle Range of Motion in Sagittal Plane During Stance Phase
Estimation of ankle range of motion in sagittal plane during stance phase by three-dimensional gait analysis.
Time frame: Between baseline and 8-10 weeks after the BoNT injections
Population: Control group: 3DGA was not performed
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Group | Change in the Kinematic Parameter Ankle Range of Motion in Sagittal Plane During Stance Phase | 0.31 Degrees |
Secondary
Change in the Kinematic Parameter Knee Range of Motion in Sagittal Plane During Stance Phase
Estimation of knee range of motion in sagittal plane during stance phase by three-dimensional gait analysis.
Time frame: Between baseline and 8-10 weeks after the BoNT injections
Population: Control group: 3DGA was not performed
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Group | Change in the Kinematic Parameter Knee Range of Motion in Sagittal Plane During Stance Phase | 3.68 Degrees |
Secondary
Change of Range of Motion in the Ankle and Knee Joint
Evaluation by goniometry expressed in degrees. For the ankle plantar flexion range of motion with the knee extended, for the hamstrings unilateral popliteal angle.
Time frame: Between baseline and 8-10 weeks after the BoNT injections
Population: A standardized clinical examination was performed during the pre- and post-BoNT-A assessments of the intervention group and during the pre-assessment of the control group. These data were used to describe and compare both groups at baseline.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention Group | Change of Range of Motion in the Ankle and Knee Joint | Plantar flexors | 0.0 Degrees |
| Intervention Group | Change of Range of Motion in the Ankle and Knee Joint | Hamstrings | 0.0 Degrees |
Secondary
Normalized Muscle Volume Growth Rates of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus
Estimation of the normalized muscle volume growth rates, calculated by (Normalized muscle volume (mL/kg\*m)post-Normalized muscle volume pre (mL/kg\*m))/(age (months)post-age (months)pre)
Time frame: Between baseline and 8-10 weeks after the BoNT injections for the intervention group, and between baseline and 8-10 weeks later for the control group.
Population: Semitendinosus:~Intervention group: n = 24 \< 25 due to bad quality data Control group: n = 19 \< 20 due to bad quality data
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention Group | Normalized Muscle Volume Growth Rates of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus | Medial Gastrocnemius | -0.02 ml/kg*m/month |
| Intervention Group | Normalized Muscle Volume Growth Rates of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus | Semitendinosus | -0.02 ml/kg*m/month |
| Control Group | Normalized Muscle Volume Growth Rates of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus | Medial Gastrocnemius | 0.01 ml/kg*m/month |
| Control Group | Normalized Muscle Volume Growth Rates of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus | Semitendinosus | -0.00 ml/kg*m/month |