Pressure Therapy in the Treatment of Upper Arm of Cerebral Palsy Children (PROPENSIX)

University Hospital, Lille

Status: Completed

Conditions: Cerebral Palsy

Treatments: Device: Proprioceptive pressure therapy; Device: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT02086214

N°19/16, Axe 1.11, (Other Grant/Funding Number)

2011_01

2011-A01129-32 (Other Identifier)

Details and patient eligibility

About

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).

Full 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)

Enrollment: 101 patients

Sex: All

Ages: 5 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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101 participants in 2 patient groups, including a placebo group

Proprioceptive pressure therapy

Experimental group

Description:

Proprioceptive pressure therapy using a a LYCRA® compressive sleeve initially used in burn therapy : 15 to 25 mmHg.

Treatment:

Device: Proprioceptive pressure therapy

Control

Placebo Comparator group

Description:

LYCRA® non-compressive sleeve initially used in burn therapy : \< 5 mmHg.

Treatment:

Device: Control