Clinical trial NCT02086214: Pressure Therapy in the Treatment of Upper Arm of Cerebral Palsy Children
Official title: Pressure Therapy in the Treatment of Upper Arm of Cerebral Palsy Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Upper limb
Proprioceptive pressure therapy
Children
Assisting Hand Assessment performance
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Marc Sautelet Centre (Villeneuve d'Ascq, France)
First posted: 2014-03-13
Enrollment: 101
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy of a 6 months upper arm proprioceptive pressure therapy on Assisting Hand Assessment ("AHA") performance in Cerebral Palsy (CP). To perform this study, 80 CP patients aged of 5 to 10 years old will be included in a multicentric, double blind, prospective parallel-group randomized study. Treatment will be a pressure therapy using a LYCRA® compressive sleeve initially used in burn therapy. Primary outcome is to increase of 60% of AHA performance. The secondary outcome are to increase Quality of Upper Extremity Skill Test (QUEST), quality of life and improve Somatosensory Evoked Potentials (SEP).

Detailed description: The purpose of this study is to assess the efficacy of a 6 months upper arm proprioceptive pressure therapy on Assisting Hand Assessment ("AHA") performance in Cerebral Palsy (CP). To perform this study, 80 CP patients aged of 5 to 10 years old will be included in a multicentric, double blind, prospective parallel-group randomized study. Treatment will be a pressure therapy using a LYCRA® compressive sleeve initially used in burn therapy. Primary outcome is to increase of 60% of AHA performance. The secondary outcome are to increase Quality of Upper Extremity Skill Test (QUEST), quality of life and improve Somatosensory Evoked Potentials (SEP)

Eligibility criteria: Inclusion Criteria:

* Children with upper limb with pre/peri birth etiologic CP.
* Children aged 5 to 10 years

Exclusion Criteria:

* Children with language dysfunction
* LYCRA® allergia
* Botulic Toxin injection on upper limb 4 month before inclusion

Primary outcomes:
measure: Assisting Hand Assessment performance
timeFrame: 6 months
Secondary outcomes:
measure: Upper Extremity skill Test (QUEST)
timeFrame: 6 months
measure: Somatosensory Evoked Potentials (SEP)
timeFrame: 6 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU
city: Creil
country: France
facility: Service d'Education et de Soins Spécialisés à domicile_APF de Creil
city: Reims
country: France
facility: CHU
city: Toulouse
country: France
facility: Centre de Soins de Suite et de Réadaptation Pédiatrique Spécialisé_Centre Paul Dottin
city: Villeneuve d'Ascq
country: France
facility: Centre Marc Sautelet
Study officials:
affiliation: Centre Marc Sautelet, Villeneuve d'Ascq, France
name: Laurent GOTTRAND, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gerard A, Toussaint-Thorin M, Mohammad Y, Letellier G, Fritot S, Masson S, Duhamel A, Donskoff C, Zagame Y, Beghin L, Gottrand L. PROPENSIX: pressure garment therapy using compressive dynamic Lycra(R) sleeve to improve bi-manual performance in unilateral cerebral palsy: a multicenter randomized controlled trial protocol. Trials. 2022 Feb 5;23(1):117. doi: 10.1186/s13063-022-06041-1.