The aims of the proposed study are (1) to test the reliability of knee moment-angle measurements, (2) 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…
ID
Source
Brief title
Condition
- Neurological disorders congenital
- Soft tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Histological, morphological and mechanical properties of the treated muscles
and tendons, and angle-moment relationship
Secondary outcome
Clinical, gait, and functional characteristics.
Background summary
Orthopaedic 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.
Study objective
The aims of the proposed study are (1) to test the reliability of knee
moment-angle measurements, (2) 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, (3) to determine the longitudinal effects
of orthopaedic surgical interventions on morphological and mechanical
properties of treated muscle, and (4) to relate these to limitations of gait
and functional performance.
Study design
Part 1: Reliability study; Part 2: 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.
Study burden and risks
Treatment of the children and control subjects for biopsies will not be delayed
or affected in any way due to the study. Most of the measurements for children
with CP are part of the standard examination in preparation of surgical
orthopaedic intervention that the children will undergo. The burdens for the
children and parents (longer examination time than normal) are low. The risks
of the additional measurements are very low. Muscle biopsies will be taken
during surgery, without any additional skin incision or prolonged anesthesia.
The research will increase our knowledge regarding the mechanisms underlying
the limited knee and ankle ROM in children with CP and will likely provide
indications for improvement of surgical orthopaedic treatment of these
children.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL36771.029.11 |
| OMON | NL-OMON27577 |