NCT02086214

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 21, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2014

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 13, 2014

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2021

Completed
Last Updated

December 22, 2025

Status Verified

April 1, 2021

Enrollment Period

8.3 years

First QC Date

February 17, 2014

Last Update Submit

December 15, 2025

Conditions

Cerebral Palsy

Keywords

Upper limbProprioceptive pressure therapyChildrenAssisting Hand Assessment performance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Upper Extremity skill Test (QUEST)

    6 months

  • Somatosensory Evoked Potentials (SEP)

    6 months

Study Arms (2)

Proprioceptive pressure therapy

EXPERIMENTAL

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

Device: Proprioceptive pressure therapy

Control

PLACEBO COMPARATOR

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

Device: Control

Interventions

Proprioceptive pressure therapyDEVICE

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

Also known as: Proprioceptive pressure therapy by Medical Z
Proprioceptive pressure therapy
ControlDEVICE

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

Control

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with upper limb with pre/peri birth etiologic CP.
  • Children aged 5 to 10 years

You may not qualify if:

  • Children with language dysfunction
  • LYCRA® allergia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHU

Amiens, France

Location

Service d'Education et de Soins Spécialisés à domicile_APF de Creil

Creil, France

Location

CHU

Reims, France

Location

Centre de Soins de Suite et de Réadaptation Pédiatrique Spécialisé_Centre Paul Dottin

Toulouse, France

Location

Centre Marc Sautelet

Villeneuve-d'Ascq, 59653, France

Location

Related Publications (1)

  • 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.

    PMID: 35123557RESULT

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Laurent GOTTRAND, MD

    Centre Marc Sautelet, Villeneuve d'Ascq, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2014

First Posted

March 13, 2014

Study Start

December 21, 2012

Primary Completion

April 7, 2021

Study Completion

April 7, 2021

Last Updated

December 22, 2025

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(5)