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

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Proprioceptive pressure therapy
Control
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Upper limb, Proprioceptive pressure therapy, Children, Assisting Hand Assessment performance

Eligibility Criteria

5 Years - 10 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • CHU
  • Service d'Education et de Soins Spécialisés à domicile_APF de Creil
  • CHU
  • Centre de Soins de Suite et de Réadaptation Pédiatrique Spécialisé_Centre Paul Dottin
  • Centre Marc Sautelet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Proprioceptive pressure therapy

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 17, 2014
Last Updated
April 14, 2021
Sponsor
University Hospital, Lille
Collaborators
Marc Sautelet Centre (Villeneuve d'Ascq, France)
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1. Study Identification

Unique Protocol Identification Number
NCT02086214
Brief Title
Pressure Therapy in the Treatment of Upper Arm of Cerebral Palsy Children
Acronym
PROPENSIX
Official Title
Pressure Therapy in the Treatment of Upper Arm of Cerebral Palsy Children
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 21, 2012 (Actual)
Primary Completion Date
April 7, 2021 (Actual)
Study Completion Date
April 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Marc Sautelet Centre (Villeneuve d'Ascq, France)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Upper limb, Proprioceptive pressure therapy, Children, Assisting Hand Assessment performance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Proprioceptive pressure therapy
Arm Type
Experimental
Arm Description
Proprioceptive pressure therapy using a a LYCRA® compressive sleeve initially used in burn therapy : 15 to 25 mmHg.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
LYCRA® non-compressive sleeve initially used in burn therapy : < 5 mmHg.
Intervention Type
Device
Intervention Name(s)
Proprioceptive pressure therapy
Other Intervention Name(s)
Proprioceptive pressure therapy by Medical Z
Intervention Description
Proprioceptive pressure therapy using a a LYCRA® compressive sleeve initially used in burn therapy : 15 to 25 mmHg.
Intervention Type
Device
Intervention Name(s)
Control
Intervention Description
LYCRA® non-compressive sleeve initially used in burn therapy : < 5 mmHg.
Primary Outcome Measure Information:
Title
Assisting Hand Assessment performance
Description
Assisting Hand Assessment performance is a functional test to assess hand function for children with unilateral upper limb disabilities.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Upper Extremity skill Test (QUEST)
Description
Upper Extremity skill Test is a functional test to assess upper limb mobility for children with unilateral upper limb disabilities.
Time Frame
6 months
Title
Somatosensory Evoked Potentials (SEP)
Description
Somatosensory Evoked Potentials (SEP) is a functional test to assess sensory nerve conduction
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent GOTTRAND, MD
Organizational Affiliation
Centre Marc Sautelet, Villeneuve d'Ascq, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU
City
Amiens
Country
France
Facility Name
Service d'Education et de Soins Spécialisés à domicile_APF de Creil
City
Creil
Country
France
Facility Name
CHU
City
Reims
Country
France
Facility Name
Centre de Soins de Suite et de Réadaptation Pédiatrique Spécialisé_Centre Paul Dottin
City
Toulouse
Country
France
Facility Name
Centre Marc Sautelet
City
Villeneuve d'Ascq
ZIP/Postal Code
59653
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35123557
Citation
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.
Results Reference
derived

Learn more about this trial

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

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