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

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).

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Device: Proprioceptive pressure therapy; Device: Control

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)

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France
    • CHU
  • Creil, France
    • Service d'Education et de Soins Spécialisés à domicile_APF de Creil
  • Reims, France
    • CHU
  • Toulouse, France
    • Centre de Soins de Suite et de Réadaptation Pédiatrique Spécialisé_Centre Paul Dottin
  • Villeneuve-d'Ascq, France, 59653
    • Centre Marc Sautelet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 10 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Marc Sautelet Centre (Villeneuve d'Ascq, France)
• Investigators: Principal Investigator: Laurent GOTTRAND, MD, Centre Marc Sautelet, Villeneuve d'Ascq, France

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2012
• Primary Completion (Actual): April 7, 2021
• Study Completion (Actual): April 7, 2021

Study Registration Dates

• First Submitted: February 17, 2014
• First Submitted That Met QC Criteria: March 11, 2014
• First Posted (Estimated): March 13, 2014

Study Record Updates

• Last Update Posted (Estimated): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Children; Upper limb; Proprioceptive pressure therapy; Assisting Hand Assessment performance
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 2011_01; N°19/16, Axe 1.11, (Other Grant/Funding Number: PHRC-2011); 2011-A01129-32 (Other Identifier: ID-RCB number, AFSSAPS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO