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| ID | Type | Description | Link |
|---|---|---|---|
| N°19/16, Axe 1.11, | Other Grant/Funding Number | PHRC-2011 | |
| 2011-A01129-32 | Other Identifier | ID-RCB number, AFSSAPS |
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| Name | Class |
|---|---|
| Marc Sautelet Centre (Villeneuve d'Ascq, France) | UNKNOWN |
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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proprioceptive pressure therapy | Experimental | Proprioceptive pressure therapy using a a LYCRA® compressive sleeve initially used in burn therapy : 15 to 25 mmHg. |
|
| Control | Placebo Comparator | LYCRA® non-compressive sleeve initially used in burn therapy : < 5 mmHg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proprioceptive pressure therapy | Device | Proprioceptive pressure therapy using a a LYCRA® compressive sleeve initially used in burn therapy : 15 to 25 mmHg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Somatosensory Evoked Potentials (SEP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laurent GOTTRAND, MD | Centre Marc Sautelet, Villeneuve d'Ascq, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU | Amiens | France | ||||
| Service d'Education et de Soins Spécialisés à domicile_APF de Creil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35123557 | Result | 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. |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Control | Device | LYCRA® non-compressive sleeve initially used in burn therapy : < 5 mmHg. |
|
Somatosensory Evoked Potentials (SEP) is a functional test to assess sensory nerve conduction
| 6 months |
| Creil |
| France |
| CHU | Reims | France |
| Centre de Soins de Suite et de Réadaptation Pédiatrique Spécialisé_Centre Paul Dottin | Toulouse | France |
| Centre Marc Sautelet | Villeneuve-d'Ascq | 59653 | France |