Cerebral PalsyPROPENSIXNCT02086214
Pressure Therapy in the Treatment of Upper Arm of Cerebral Palsy Children
A study testing Proprioceptive pressure therapy in people with Cerebral Palsy, run by University Hospital, Lille at 5 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Proprioceptive pressure therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 5 sitesFrance
- Study dates
- 21 Dec 2012to 7 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with upper limb with pre/peri birth etiologic CP.
- Children aged 5 to 10 years
Who cannot join
- Children with language dysfunction
- LYCRA® allergia
- Botulic Toxin injection on upper limb 4 month before inclusion
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU
Amiens
Service d'Education et de Soins Spécialisés à domicile_APF de Creil
Creil
CHU
Reims
Centre de Soins de Suite et de Réadaptation Pédiatrique Spécialisé_Centre Paul Dottin
Toulouse
Centre Marc Sautelet
Villeneuve-d'Ascq, 59653
About this study
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).
Read the 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)
- Conditions
- Cerebral Palsy
- Being tested
- Proprioceptive pressure therapy, Control
- Keywords
- Upper limb, Proprioceptive pressure therapy, Children, Assisting Hand Assessment performance
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive pressure therapyDevice
Also called Proprioceptive pressure therapy by Medical Z
Proprioceptive pressure therapy using a a LYCRA® compressive sleeve initially used in burn therapy : 15 to 25 mmHg.
ControlDevice
LYCRA® non-compressive sleeve initially used in burn therapy : < 5 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| Proprioceptive pressure therapy | Experimental | Proprioceptive pressure therapy using a a LYCRA® compressive sleeve initially used in burn therapy : 15 to 25 mmHg. Receives: Device: Proprioceptive pressure therapy |
| Control | Placebo comparator | LYCRA® non-compressive sleeve initially used in burn therapy : < 5 mmHg. Receives: Device: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assisting Hand Assessment performance
Assisting Hand Assessment performance is a functional test to assess hand function for children with unilateral upper limb disabilities.
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 6 months
Somatosensory Evoked Potentials (SEP)
Somatosensory Evoked Potentials (SEP) is a functional test to assess sensory nerve conduction
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study start21 Dec 2012
- Primary completion7 Apr 2021
- Study completion7 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Marc Sautelet Centre (Villeneuve d'Ascq, France)
- Responsible party
- Sponsor
- Investigators
- Laurent GOTTRAND, MD, Principal investigator, Centre Marc Sautelet, Villeneuve d'Ascq, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02086214
- Sponsor's protocol ID
- 2011_01
- Other IDs
- N°19/16, Axe 1.11,, 2011-A01129-32
- Acronym
- PROPENSIX
- Status last verified
- Apr 2021
- First submitted
- 17 Feb 2014
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 35123557
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pressure Therapy in the Treatment of Upper Arm of Cerebral Palsy Children
- ClinicalTrials.gov ID
- NCT02086214
- Acronym / sponsor ID
- PROPENSIX / 2011_01
- Conditions
- Cerebral Palsy
- Keywords
- Upper limb, Proprioceptive pressure therapy, Children, Assisting Hand Assessment performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Marc Sautelet Centre (Villeneuve d'Ascq, France)
- Study start
- 21 Dec 2012 (actual)
- Primary completion
- 7 Apr 2021 (actual)
- Study completion
- 7 Apr 2021 (actual)
- First posted
- 13 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proprioceptive pressure therapy | Experimental | Device: Proprioceptive pressure therapyProprioceptive pressure therapy using a a LYCRA® compressive sleeve initially used in burn therapy : 15 to 25 mmHg. |
| Control | Placebo comparator | Device: ControlLYCRA® non-compressive sleeve initially used in burn therapy : < 5 mmHg. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children with upper limb with pre/peri birth etiologic CP.
- Children aged 5 to 10 years
Key exclusion criteria (3 listed)
- Children with language dysfunction
- LYCRA® allergia
- Botulic Toxin injection on upper limb 4 month before inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proprioceptive pressure therapyAlso: Proprioceptive pressure therapy by Medical ZProprioceptive pressure therapy using a a LYCRA® compressive sleeve initially used in burn therapy : 15 to 25 mmHg. | Device | Proprioceptive pressure therapy |
| ControlLYCRA® non-compressive sleeve initially used in burn therapy : < 5 mmHg. | Device | Control |
Primary outcome
Assisting Hand Assessment performance
Time frame: 6 months
Assisting Hand Assessment performance is a functional test to assess hand function for children with unilateral upper limb disabilities.
2 secondary outcomes
Upper Extremity skill Test (QUEST)
Time frame: 6 months
Somatosensory Evoked Potentials (SEP)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Results publication: PubMed 35123557Gerard 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent GOTTRAND, MD principal investigator
Centre Marc Sautelet, Villeneuve d'Ascq, France
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioceptive pressure therapy in people with Cerebral Palsy, run by University Hospital, Lille at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assisting Hand Assessment performance (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02086214, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.