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Lycra garments have recently been used for children with cerebral palsy, with favorable effects on alignment, biomechanics and neuromuscular activity. The aim of the present study is to determine the efficacy of a Lycra suit in improving motor function and static balance in children with cerebral palsy. The children included in this study will be part of a prospective project on children with cerebral palsy, older than 4 years of age, and their families regularly followed at the Child Neurology Unit of the Catholic University of Rome.
A total of 10 children with cerebral palsy will be recruited and included in the study. Five of them will be considered as study group and will wear a lycra suit, with shoulder, trunk and pelvis coverage, for more than 4 hours per day for 6 months. The other 5 will be considered as control group, matched for age and sex to the study group, and will not wear the lycra suit. The evaluation of static balance and the gross motor function measure will be used as outcome measure. The children of both groups will be assessed twice, at baseline and 6 months after, each child acting as his/her own control.
The motor function assessments will be performed without the Lycra suit, whereas the static balance assessments were performed with and without the suit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cerebral Palsy-Study group | Experimental | The intervention consisted of wearing a lycra suit, with shoulder, trunk and pelvis coverage, for more than 4 hours per day for 6 months. The motor function assessments will be performed without the Lycra suit, whereas the static balance assessments were performed with and without the suit. |
|
| Cerebral Palsy-Control Group | Active Comparator | Children with clinical characteristics similar to the study group; they will be assessed using the same protocol but with no use of lycra garments |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lycra suit and physiotherapy treatment | Other | Garments will be fitted by an occupational therapy with the treating therapist and child neurologist present. The garments will be constructed of Lycra with the possibility of adding reinforcing panels or derotation bands. All the children will be involved in regular physiotherapy treatment (2-3/week). |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline evaluation of static balance at 6 months | The evaluation of static balance will be assessed by a "seated stabilometry exam" performed on a "Prokin PK 254 P" device produced by TecnoBody S.r.l. (Dalmine BG - Italy). This device consists of a static plate (47 centimeters of circumference) equipped internally with four piezoelectric sensors positioned at the extremity of the four cardinals points. | The children were assessed twice, at baseline and 6 months after, each child acting as his/her own control. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Gross Motor Function Classification System at 6 months | The Gross Motor Function Measure (GMFM) will be used to evaluate gross motor function quantitatively. The GMFM consists of 88 items grouped into 5 dimensions: A (lying and rolling), B (sitting), C (crawling and kneeling), D (standing), E (walking, running and jumping). Scores for each dimension are expressed as a percentage of the maximum score for that dimension. A total score is obtained by adding the scores for all dimensions and dividing by 5, ranging from 0 to 100. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Domenico Romeo, MD, PhD | Contact | domenicomarco.romeo@policlinicogemalli.it |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16028646 | Result | Himmelmann K, Hagberg G, Beckung E, Hagberg B, Uvebrant P. The changing panorama of cerebral palsy in Sweden. IX. Prevalence and origin in the birth-year period 1995-1998. Acta Paediatr. 2005 Mar;94(3):287-94. doi: 10.1111/j.1651-2227.2005.tb03071.x. | |
| 19440130 | Result | Flanagan A, Krzak J, Peer M, Johnson P, Urban M. Evaluation of short-term intensive orthotic garment use in children who have cerebral palsy. Pediatr Phys Ther. 2009 Summer;21(2):201-4. doi: 10.1097/PEP.0b013e3181a347ab. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 24, 2017 | |
| Reset | Nov 9, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 24, 2017 | Nov 9, 2017 |
| 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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| physiotherapy treatment | Other | All the children will be involved in regular physiotherapy treatment (2-3/week). |
|
| The children were assessed twice, at baseline and 6 months after, each child acting as his/her own control. |
| 19961295 | Result | Matthews MJ, Watson M, Richardson B. Effects of dynamic elastomeric fabric orthoses on children with cerebral palsy. Prosthet Orthot Int. 2009 Dec;33(4):339-47. doi: 10.3109/03093640903150287. |