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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A01082-53 | Other Identifier | ANSM |
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Children with cerebral palsy present early in the childhood altered muscular properties, characterized by short muscle belly length and increased stiffness which contribute to contracture and limiting joint range of motion. In order to prevent equinus deformity, ankle foot orthoses for night splinting are usually used in children with spastic Cerebral Palsy (CP). However, there's a lack of proof about efficacy by using this modality of treatment. Moreover, impact on quality of life for children and families, cost for society were high.
Principal purpose of this study was to assess impact of night splint ankle foot orthoses on passive stiffness in plantarflexors muscles in children with CP.
Children with cerebral palsy present early in the childhood altered muscular properties, characterized by short muscle belly length and increased stiffness which contribute to contracture and limiting joint range of motion. In order to prevent equinus deformity, ankle foot orthoses for night splinting are usually used in children with spastic CP. However, there's a lack of proof about efficacy by using this modality of treatment. Moreover, impact on quality of life for children and families, cost for society were high.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children with Cerebral Palsy | Experimental | Children with Cerebral Palsy (CP) will be included. They will have to wearing of night splint ankle foot orthoses (phase A) and then no wearing of night splint ankle foot orthoses (phase B). The phases A and B will be repeated twice. In more, they will have an ultrasound, isokinetic dynamometer and measure of quality of night sleeping. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wearing of night splint ankle foot orthoses (phase A) | Procedure | Children wearing of night splint ankle foot orthoses during 6, 7 or 8 days according to the position of inclusion. An ultrasound of the leg muscles will be realized every morning after removing night splint. An isokinetic dynamometer will be realize at the beginning of the study and at the end of each phase. measure of quality of night sleeping will be measured by Visual Analog Scale (VAS) results. |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline elasticity modulus of the leg muscles at 4 weeks | measured by ultrasounds | Weeks 0, 1, 2, 3 and 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal dorsiflexion angle | Measured by isokinetic dynamometer. | Weeks 0, 1, 2, 3 and 4 |
| Maximum angle of tense knee dorsiflexion | Measured by isokinetic dynamometer. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vincent GAUTHERON, MD PhD | CHU de Saint Etienne | Principal Investigator |
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| No wearing of night splint ankle foot orthoses (phase B) | Procedure | Children no wearing of night splint ankle foot orthoses during 6, 7 or 8 days according to the position of inclusion. An ultrasound of the leg muscles will be realized every morning after removing night splint. An isokinetic dynamometer will be realize at the beginning of the study and at the end of each phase. measure of quality of night sleeping will be measured by Visual Analog Scale (VAS) results. |
|
| Weeks 0, 1, 2, 3 and 4 |
| Torque of force maximal tolerated in maximum angle of tense knee dorsiflexion | Measured by isokinetic dynamometer. | Weeks 0, 1, 2, 3 and 4 |
| Visual Analog Scale of sleeping | Measured the quality of night sleeping between 0 (bad sleeping) and 10 (good sleeping). | Weeks 0, 1, 2, 3 and 4 |
| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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