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

Not Applicable

Recruiting

Conditions: G80
Cerebral palsy

Registration Number: DRKS00004723

Lead Sponsor: VU University Medical Center Department of Rehabilitation Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 46

Inclusion Criteria

(1.) 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);

Exclusion Criteria

(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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Histological, 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.<br>Measurements will be performed before surgery (baseline), 6-12 weeks, 6 month, 12 month and 24 month after surgery. Muscle and tendon biopsies will be taken only once, during surgery.

Secondary Outcome Measures

Name	Time	Method
Clinical, 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.<br>Measurements will be performed before surgery (baseline), 6-12 weeks, 6 month, 12 month and 24 month after surgery.