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

Cerebral Palsy Clinical Trial

— PROPENSIX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02086214
• Other study ID #: 2011_01
• Secondary ID: N°19/16, Axe 1.1
• Status: Completed
• Phase: N/A
• Start date: December 21, 2012
• Est. completion date: April 7, 2021

Study information

• Verified date: April 2021
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: April 7, 2021
• Est. primary completion date: April 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Device:
• Proprioceptive pressure therapy
Proprioceptive pressure therapy using a a LYCRA® compressive sleeve initially used in burn therapy : 15 to 25 mmHg.
• Control
LYCRA® non-compressive sleeve initially used in burn therapy : < 5 mmHg.

Locations

Country	Name	City	State
France	CHU	Amiens
France	Service d'Education et de Soins Spécialisés à domicile_APF de Creil	Creil
France	CHU	Reims
France	Centre de Soins de Suite et de Réadaptation Pédiatrique Spécialisé_Centre Paul Dottin	Toulouse
France	Centre Marc Sautelet	Villeneuve d'Ascq

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Marc Sautelet Centre (Villeneuve d'Ascq, France)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Somatosensory Evoked Potentials (SEP)	Somatosensory Evoked Potentials (SEP) is a functional test to assess sensory nerve conduction	6 months