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

Completed
Conditions
10041297
Cerebral palsy
spastic children
10029299
Registration Number
NL-OMON41324
Lead Sponsor
Vrije Universiteit Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
86
Inclusion Criteria

Patients
1. Clinical diagnosis of spastic cerebral palsy
2. Indication for surgical lengthening of thigh and/or calf muscles / or injections with Botuline A-Toxine in combination with a bony procedure targeting the increase of knee extension
3. Gross Motor Function Classification System Class I-III (ability to walk with or without aids)
4. Age: 6-20 years ;Patients for reliability-study
1. Clinical diagnosis of spastic cerebral palsy
2. Gross Motor Function Classification System Class I-III (ability to walk with or without aids)
3. Age: 8-16 years
Control group (2 groups, for detailed description see protocol page 12/13):
1st:
1. Typically developing and healthy persons
2. Age: 6-20 years
2nd:
1. Planned surgical intervention during which harvesting of a control biopsy is possible without an additional skin incision or prolonged anaesthesia
2. Age: 6-40 years;Typically developing children for reliability study
1. Age: 6-40 years

Exclusion Criteria

Patients
1. 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;Patients for reliability-study & 1st Control group:
Same as 1., 3. and 7. for patients;2nd control group:
Sames as for patient

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Histological, morphological and mechanical properties of the treated muscles<br /><br>and tendons, and angle-moment relationship</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Clinical, gait, and functional characteristics.</p><br>
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