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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02086214
Acronym
PROPENSIX
Enrollment
101
Registered
2014-03-13
Start date
2012-12-21
Completion date
2021-04-07
Last updated
2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

Keywords

Upper limb, Proprioceptive pressure therapy, Children, Assisting Hand Assessment performance

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)

Interventions

DEVICEProprioceptive pressure therapy

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

DEVICEControl

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

Sponsors

Marc Sautelet Centre (Villeneuve d'Ascq, France)
CollaboratorUNKNOWN
University Hospital, Lille
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
5 Years to 10 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Assisting Hand Assessment performance6 monthsAssisting Hand Assessment performance is a functional test to assess hand function for children with unilateral upper limb disabilities.

Secondary

MeasureTime frameDescription
Upper Extremity skill Test (QUEST)6 monthsUpper Extremity skill Test is a functional test to assess upper limb mobility for children with unilateral upper limb disabilities.
Somatosensory Evoked Potentials (SEP)6 monthsSomatosensory Evoked Potentials (SEP) is a functional test to assess sensory nerve conduction

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026