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van CCT (UK)

van CCT (UK)

Muscle properties in children with cerebral palsy undergoing orthopaedic surgical intervention to improve gait.

- candidate number10246
- NTR NumberNTR3042
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-aug-2011
- Secondary IDsNL36771.029.11 / 2011/135; CCMO / METC VUmc
- Public TitleMuscle properties in children with cerebral palsy undergoing orthopaedic surgical intervention to improve gait.
- Scientific TitleMuscle properties in children with cerebral palsy undergoing orthopaedic surgical intervention to improve gait.
- hypothesisWe hypothesize that the success of surgical intervention of calf and knee flexor muscles to improve gait is determined by muscle properties and the adaptation of these muscles after surgery.
- Healt Condition(s) or Problem(s) studiedCerebral palsy, Surgery, Muscles
- Inclusion criteria1. Clinical diagnosis of spastic cerebral palsy;
2. Indication for surgical lengthening of thigh and/or calf muscles;
3. Gross Motor Function Classification System Class I-III (ability to walk with or without aids);
4. Age: 6-20 years.
- Exclusion criteria1. Treatment of muscles, which are indicated for surgical procedures, with Botuline A-Toxine within three months before surgery;
2. A pre-surgical treatment with selective dorsal rhizotomy, intrathecal baclofen pump or prior surgery of treated muscle;
3. Major disease or accident one year prior to measurements or a disturbed normal activity level of the child for more than three weeks in the last half year;
4. 24-hour casting for more than two weeks, that includes the treated muscle three month prior to surgery;
5. Additional neuromuscular, orthopaedic, inflammatory or systemic diseases which can influence walking ability or muscle properties;
6. Medication that influences neuromuscular properties three month prior to surgery;
7. Parents/guardians or child do not cooperate well enough to take part in the project.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-sep-2011
- planned closingdate1-sep-2014
- Target number of participants46
- InterventionsSurgical lengthening of the muscle tendon complex of thigh and calf muscles to increase the range of motion of the knee or ankle or both to improve gait.
- Primary outcomeHistological, morphological and mechanical properties of the treated muscles and tendons, and angle-moment relationship. These will be determined by muscle and tendon biopsies, muscle ultrasound measurements and moment-angle measurements.
- Secondary outcomeClinical, gait, and functional characteristics. Following measurements will be used: Gross Motor Function Measurement (GMFM), 6-minute walk test, Functional Mobility Scale (FMS), Mobility Questionnaire (MobQuest28), Mobility part of the Pediatric Evaluation Disability Inventory (PEDI), clinical physical examination and gait analysis.
- TimepointsMeasurements will be performed before surgery (baseline), 6 weeks, 6 month, 12 month and 24 month after surgery. Muscle and tendon biopsies will be taken only once, during surgery.
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator VU University Medical Center, Department of Rehabilitation Medicine
- Funding
(Source(s) of Monetary or Material Support)
Dr. W.M. Phelps-stichting voor spastici
- PublicationsN/A
- Brief summaryOrthopaedic surgical interventions to improve gait in children with cerebral palsy (CP) have high recurrence and re-operation rate. The effects of these interventions on muscle architecture and how this relates to changes in the range of knee and ankle motion and gait are unknown.
The aims of the proposed study are (1) to obtain insight how muscle and tendon characteristics in children with CP contribute to the limitations in range of motion (ROM) of the knee and ankle, (2) to determine the longitudinal effects of orthopaedic surgical interventions on morphological and mechanical properties of treated muscle, and (3) to relate these to limitations of gait and functional performance.
An observational study using a longitudinal design to determine the effects of intervention; the pre-surgical situation of children with CP will be compared cross-sectionally with typically developing children.
- Main changes (audit trail)
- RECORD16-aug-2011 - 11-sep-2011

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