Pressure Therapy in the Treatment of Upper Arm of Cerebral Palsy Children

Study Overview
=================
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)

Official Title
-----------------
Pressure Therapy in the Treatment of Upper Arm of Cerebral Palsy Children

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Device: Proprioceptive pressure therapy
* Device: Control


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 10 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proprioceptive pressure therapy<br>Proprioceptive pressure therapy using a a LYCRA® compressive sleeve initially used in burn therapy : 15 to 25 mmHg. | Device: Proprioceptive pressure therapy<br>* Proprioceptive pressure therapy using a a LYCRA® compressive sleeve initially used in burn therapy : 15 to 25 mmHg.<br>* Other names: Proprioceptive pressure therapy by Medical Z;|
| Placebo Comparator: Control<br>LYCRA® non-compressive sleeve initially used in burn therapy : < 5 mmHg. | Device: Control<br>* LYCRA® non-compressive sleeve initially used in burn therapy : < 5 mmHg.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assisting Hand Assessment performance | Assisting Hand Assessment performance is a functional test to assess hand function for children with unilateral upper limb disabilities. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper Extremity skill Test (QUEST) | Upper Extremity skill Test is a functional test to assess upper limb mobility for children with unilateral upper limb disabilities. | 6 months | 
| Somatosensory Evoked Potentials (SEP) | Somatosensory Evoked Potentials (SEP) is a functional test to assess sensory nerve conduction | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Assisting Hand Assessment performance, Upper limb, Proprioceptive pressure therapy, Children