Effects of Lycra Suits in Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

— CP  

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02712021
• Other study ID #: 27711/14
• Status: Not yet recruiting
• Phase: N/A
• First received: March 9, 2016
• Last updated: March 16, 2016
• Start date: April 2016
• Est. completion date: December 2016

Study information

• Verified date: March 2016
• Source: Catholic University, Italy
• Contact: Domenico Romeo, MD, PhD
• Email: domenicomarco.romeo[@]policlinicogemalli.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of cerebral palsy based on the predominant type of motor impairment and classified according to the criteria proposed by Himmelmann.

Exclusion Criteria:

• Presence of major congenital malformations or metabolic or haematological complications.

• The investigators will also exclude children who had previously worn a lycra garment and who received Botulinum toxin injections or orthopaedic surgery in the year before the study.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Other:
• Lycra suit and physiotherapy treatment
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).
• physiotherapy treatment
All the children will be involved in regular physiotherapy treatment (2-3/week).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University, Italy

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	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.	The children were assessed twice, at baseline and 6 months after, each child acting as his/her own control.