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NCT Number: NCT02086214

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

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).

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU, Amiens, France

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proprioceptive pressure therapy

Device

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

Control

Device

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

Primary outcomes

  1. Assisting Hand Assessment performance

    Time frame: 6 months

    Assisting Hand Assessment performance is a functional test to assess hand function for children with unilateral upper limb disabilities.

Secondary outcomes

  1. Upper Extremity skill Test (QUEST)

    Time frame: 6 months

    Upper Extremity skill Test is a functional test to assess upper limb mobility for children with unilateral upper limb disabilities.

  2. Somatosensory Evoked Potentials (SEP)

    Time frame: 6 months

    Somatosensory Evoked Potentials (SEP) is a functional test to assess sensory nerve conduction

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Marc Sautelet Centre (Villeneuve d'Ascq, France)

Registry information

Acronym: PROPENSIX

Important dates

Study start
2012
Primary completion
2021
Study completion
2021
First posted
Mar 13, 2014
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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