Acquired Traumatic Spinal Cord Injury Clinical Trial
— ESTIMEOfficial title:
Analysis of Psychosocial Determinants of Observance of Monitoring Neuro-urological in Spina-bifida Adult Patients and in Spinal Cord Injury Patients: a Prospective, Comparative, Multicenter With Parallel Groups Study
| Verified date | April 2021 |
| Source | Rennes University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
With improved life expectancy over the last fifty years, spina bifida has become a disease of the adult. One of the major stakes for these patients is the preservation of a regular follow-up of uro-nephrologicals risk factors and of a respect for the rules of self management of their neurological bladder. The main objective of this study is to highlight a difference in the level of global self-esteem among a population of adult patients with spina bifida and a population of adult patients with traumatic spinal cord injury gained the same level of neurological.
| Status | Terminated |
| Enrollment | 111 |
| Est. completion date | September 11, 2017 |
| Est. primary completion date | September 11, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility | Inclusion Criteria: - Patients with a spina bifida aperta or an acquired traumatic spinal cord injury dating more than two years, the level of injury being below D12 and higher S1 (Score ASIA A). - Age between 18 and 60 - Knowing how to read, write, count - Having given their free, informed and in writing consent (an information is also given to the reliable person when it exists) - Affiliated to the National Health Service Exclusion Criteria: - Psychiatric history requiring an hospitalization in a specialized unit during more than two months - Score MMS lower than 27 ( GRECO version) - Serious associated pathology or associated pathology which could interfer with the management of vesico-sphincteral disorders - Neurosurgery, dating from less than one year - Symptoms of dysfunction of ventricular bypass valve at the time of inclusion - Clinical epileptic attack within six months prior to inclusion - Pregnancy or breastfeeding - Simultaneous inclusion in an another therapeutic protocol or period of exclusion from an another protocol - Traumatic spinal cord injury acquired before age 16 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU de Besançon | Besançon | |
| France | Clinique Saint Augustin | Bordeaux | |
| France | CHU de Lille | Lille | |
| France | Urologie CH Lyon Sud et Hôpital Henry Gabrielle | Lyon | |
| France | APHM - Hôpital de la Conception Service de chirurgie urologique et transplantation rénale | Marseille | |
| France | MPR neurologique CHU de Nantes | Nantes | |
| France | APHP Raymond Poincaré | Paris | |
| France | APHP Rothschild | Paris | |
| France | Neuro-urologie et explorations périnéales, APHP Tenon | Paris | |
| France | Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de KERPAPE | Ploemeur | |
| France | CHU de Rennes CR Spina bifida | Rennes | |
| France | Hôpital Pontchaillou - CHU de Rennes | Rennes | |
| France | MPR St Hélier | Rennes | |
| France | Urologie, CHU de Rouen | Rouen | |
| France | MPR CHU Rangueuil | Toulouse | |
| France | Urologie CHU Rangueuil Toulouse | Toulouse |
| Lead Sponsor | Collaborator |
|---|---|
| Rennes University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Measure of the global self-esteem by the Rosenberg scale (RSES) | Score range : 10 - 40. High scores indicate hight self esteem. | At day 0 | |
| Secondary | Evaluation of depression and anxiety by Hamilton's scale (HAD) | Score range : 0 - 21. High scores indicate a hight level of symptoms. | At day 0, at month 6 | |
| Secondary | Neuropsychological evaluation (WAIS-III battery composite GREFEX, CVLT) | Battery of test exploring executives functions. High scores indicate high level of executive functions. | At day 0 | |
| Secondary | Rating Scale vesico-sphincter and anorectal function (ISCOS) | High scores indicate high vesico-sphincter and anorectal dysfunction | At day 0, at month 6 | |
| Secondary | Evaluation scale for the achievement of self catheterizing | 14 binary items | At day 0, at month 6 | |
| Secondary | Scale functional mobility and transfers (SCIM III) | The SCIM is a disability scale in order to describe patients' ability to accomplish activities of daily living and to make functional assessments of this population more sensitive to changes. SCIM-III is comprised of 19 items in 3 subscales, which are: (i) self-care (sub-score 0-20); (ii) respiration and sphincter management (sub-score 0-40); (iii) mobility (sub-score 0-40). The mobility subscale is further sub-divided to assess mobility "in room and toilet" and for "indoors and outdoors, on an even surface". The total score ranges from 0 to 100. |
At day 0 | |
| Secondary | Measure of the global self-esteem by the Rosenberg scale (RSES) | Score range : 10 - 40. High scores indicate hight self esteem. | At month 6 | |
| Secondary | Observance of the appointment | At month 6 | ||
| Secondary | Observance of holding of the mictionnel catalog | At month 6 | ||
| Secondary | Measure of auto-efficiency experienced scale for Medullary Injured (MSES) | 16 items ranging from 1 to 7 Range 16 - 112 High scores correspond to low level of percieved auto-efficiency |
At Day 0 |