Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06351189
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-02
Brief Title:
NETTI Wheelchair Does Dynamic Mode or Static Mode Affect the Sitting Position in Patients With Involuntary Movements
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Organization:
Centre Hospitalier Universitaire de Nīmes
Study Overview
Official Title:
Performance Evaluation of the NETTI Wheelchair in Dynamic Mode for Subjects With Involuntary Movements With an Impact on Sitting Position Compared With Its Static Mode Single-case Experimental Design
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DYNAMIC SYSTEM
Brief Summary:
This study compares two modes of the NETTI wheelchair dynamic or sitting for patients with hyperkinetic syndromes to discover which mode is the most comfortable and best suited to these patients
It is a prospective single-center pilot study comparing two medical devices evaluated using SCED Single Case Experimental Design ABAB methodology NETTI DYNAMIC chair in dynamic mode intervention group phase B versus the same chair in static mode control group phase A The subject will be hisher own control
It is a prospective single-center pilot study comparing two medical devices evaluated using SCED Single Case Experimental Design ABAB methodology NETTI DYNAMIC chair in dynamic mode intervention group phase B versus the same chair in static mode control group phase A The subject will be hisher own control
Detailed Description:
Hyperkinetic syndromes are characterized by excessive or involuntary movements throughout the day These abnormal movements interfere with maintaining the ideal sitting position and cause positioning disorders that may have functional repercussions To facilitate staying in the ideal position therapists adapt sitting positions Together with the patient they choose the position that appears to be the most functional and comfortable To maintain this position the solutions proposed are mainly based on restraint shells abduction blocks straps etc These can be poorly tolerated by the patient causing discomfort or even pain which can hinder participation Repeated stresses on the supports and on the chair itself leads to frequent breakage Also depending on the underlying neurological mechanisms behind the abnormal movements the question arises as to whether restraint increases the frequency or amplitude of abnormal movements by generating oppositional constraints areas of discomfort andor pain or by reducing functional capacities and frustration caused by these abnormal movements Cimolin et al 2009 All these issues can have a significant impact on the quality of life of this population of patients suffering from abnormal movements and who are almost exclusively in wheelchairs To address these issues dynamic wheelchair systems have been have been developed to absorb the mechanical stresses generated by abnormal movements
The chairs dynamic components absorb the force When the patients force ceases the stored energy is returned by the dynamic component which in turn helps the patient return to his or her starting position The ideal seating system enables controlled movement whilst providing mechanical stability
This is a prospective single-center pilot study comparing the two medical device modes using an ABAB-type Single Case Experimental Design methodology The NETTI DYNAMIC chair in dynamic mode interventional group phase B versus the same chair in static mode control group phase A The subject will be hisher own control
Phase B intervention will be performed by positioning the subject on the Netti Dynamic chair in its dynamic configuration Phase A control on the other hand will be performed positioned on the same chair but in static mode backrest and seat locked by means of a jack and pin legrest and headrest replaced by standard elements and headrest replaced by standard components making it impossible to adapt the chairs of the chair In this way the specific effect of the dynamic mode will be able to be controlled
The ABAB study design was chosen for this study because it provides the highest level of evidence evidence Level 1 OCEBM Levels of Evidence Working Group 2011 The Oxford 2011 Levels of Evidence Oxford Centre for Evidence-Based Medicine It is characterized by the presence of two phases phase A control phase and phase B intervention phase which are alternated twice
Each phase must comprise three to five measures to enable reliable statistical analysis This approach is particularly appropriate for evaluating medical devices especially when the when the population concerned is heterogeneous Indeed an intensive prospective study of a few individuals using a methodology defined a priori including systematic observations repeated measurements and appropriate data analysis is the most appropriate in this case
The chairs dynamic components absorb the force When the patients force ceases the stored energy is returned by the dynamic component which in turn helps the patient return to his or her starting position The ideal seating system enables controlled movement whilst providing mechanical stability
This is a prospective single-center pilot study comparing the two medical device modes using an ABAB-type Single Case Experimental Design methodology The NETTI DYNAMIC chair in dynamic mode interventional group phase B versus the same chair in static mode control group phase A The subject will be hisher own control
Phase B intervention will be performed by positioning the subject on the Netti Dynamic chair in its dynamic configuration Phase A control on the other hand will be performed positioned on the same chair but in static mode backrest and seat locked by means of a jack and pin legrest and headrest replaced by standard elements and headrest replaced by standard components making it impossible to adapt the chairs of the chair In this way the specific effect of the dynamic mode will be able to be controlled
The ABAB study design was chosen for this study because it provides the highest level of evidence evidence Level 1 OCEBM Levels of Evidence Working Group 2011 The Oxford 2011 Levels of Evidence Oxford Centre for Evidence-Based Medicine It is characterized by the presence of two phases phase A control phase and phase B intervention phase which are alternated twice
Each phase must comprise three to five measures to enable reliable statistical analysis This approach is particularly appropriate for evaluating medical devices especially when the when the population concerned is heterogeneous Indeed an intensive prospective study of a few individuals using a methodology defined a priori including systematic observations repeated measurements and appropriate data analysis is the most appropriate in this case
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None