NETTI Wheelchair: Does Dynamic Mode or Static Mode Affect the Sitting Position in Patients With Involuntary Movements ?

NCT ID: NCT06351189

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-19
• Study Completion Date: 2024-12-05

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 his/her 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 and/or 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 chair's dynamic components absorb the force. When the patient's 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 his/her 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 chair's 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.

Conditions

Hyperextension Spasms; Involuntary Movements

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Control group: STATIC MODE

The patient will be positioned on the Netti Dynamic chair in static mode.

Observation

Intervention Type: DEVICE

Patients will be filmed in sitting position in the NETTI DYNAMIC chair, either in static mode or dynamic mode for a period of 3 hours each time.

Interventional group: DYNAMIC MODE

The patient will be positioned on the Netti Dynamic chair in dynamic mode.

Observation

Intervention Type: DEVICE

Patients will be filmed in sitting position in the NETTI DYNAMIC chair, either in static mode or dynamic mode for a period of 3 hours each time.

Interventions

Observation

Patients will be filmed in sitting position in the NETTI DYNAMIC chair, either in static mode or dynamic mode for a period of 3 hours each time.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient with involuntary extension movements with a frequency greater than (>) 3/hour and requiring at least one wheelchair repositioning every 2 hours.
• Patient using a wheelchair and requiring to be in a seated position at least 4 hours per day.
• Patient and/or representative with free and informed consent.
• Patient and/or representative having signed the consent form.
• Patient affiliated or beneficiary of a health insurance plan.
• Patient over 16 years of age (≥16 years).

Exclusion Criteria

• Patient unable to sit in chair for at least 3 hours a day.
• Patient unable to sit in the chair without the use of a thermoformed corset.
• Patients weighing over 135kg.
• Patient participating in a drug study.
• Patient in an exclusion period determined by another study.
• Patient/legal representative for whom it is impossible to provide informed information.
• Pregnant or breast-feeding patient

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anissa MEGZARI

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire de Nīmes

Locations

CHU de Nîmes

Nîmes, , France

Countries

France

Other Identifiers

CIVI/2022/AD-01

Identifier Type: -

Identifier Source: org_study_id