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

NCT ID: NCT02086214

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-21

Study Completion Date

2021-04-07

Brief Summary

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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

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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)

Conditions

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Cerebral Palsy

Keywords

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Upper limb Proprioceptive pressure therapy Children Assisting Hand Assessment performance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Proprioceptive pressure therapy

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

Group Type EXPERIMENTAL

Proprioceptive pressure therapy

Intervention Type DEVICE

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

Control

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

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DEVICE

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

Interventions

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Proprioceptive pressure therapy

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

Intervention Type DEVICE

Control

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

Intervention Type DEVICE

Other Intervention Names

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Proprioceptive pressure therapy by Medical Z

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marc Sautelet Centre (Villeneuve d'Ascq, France)

UNKNOWN

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurent GOTTRAND, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Marc Sautelet, Villeneuve d'Ascq, France

Locations

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CHU

Amiens, , France

Site Status

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

Creil, , France

Site Status

CHU

Reims, , France

Site Status

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

Toulouse, , France

Site Status

Centre Marc Sautelet

Villeneuve-d'Ascq, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 35123557 (View on PubMed)

Other Identifiers

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N°19/16, Axe 1.11,

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2011-A01129-32

Identifier Type: OTHER

Identifier Source: secondary_id

2011_01

Identifier Type: -

Identifier Source: org_study_id