TOPCHAIR-S - 11 janvier 2011 (3005) avis - TOPCHAIR-S (3005) English version
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pages
English
Documents
2011
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11 janvier 2011
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English
Laboratory / Manufacturer TOPCHAIR SAS (France) Posted on Jan 28 2011 Powered wheelchair with stair-climbing capability Posted on Jan 28 2011
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Publié par
Publié le
11 janvier 2011
Licence :
Paternité, pas d'utilisation commerciale, partage des conditions initiales à l'identique
Langue
English
The legally binding text is the original French version
NATIONAL COMMITTEE FOR THE EVALUATION OF MEDICAL DEVICES AND HEALTH TECHNOLOGIES (CNEDiMTS) OPINION 11 January 2011
Name: Models and references involved: Manufacturer and applicant: Available data:
Actual Benefit (AB):
Indications:
CONCLUSIONS TOPCHAIR-S, powered wheelchair with stair-climbing capability TOPCHAIR-S
TOPCHAIR SAS (France)
The opinion of theTOPCHAIR-S dated 11 July 2007 was Committee on based on one single-centre, prospective, comparative, randomised cross-over study. This study involved 25 patients with functional quadriplegia who required a powered wheelchair because of loss of ambulation associated with upper limb motor deficit. There were two objectives: - to compare the performance of TOPCHAIR-S with that of the STORM3 wheelchair (a currently-used powered wheelchair). - to assess the stair-climbing capability of TOPCHAIR-S. A retrospective study involving the whole range of TOPCHAIR-S wheelchairs sold in France, in 2009 and 2010 respectively. Eleven TOPCHAIR-S wheelchairs were sold for individual use and delivered to users during this period: 7 patients responded, 3 were not using TOPCHAIR-S because of their state of health (readmission to hospital), and 1 patient could not be contacted. The endpoints were: increased independence provided to the user by the stair-climbing capability, assessed using the Wheelchair Outcome Measure (WhOM - a modified French-language version was used for this study), user satisfaction with TOPCHAIR-S measured using the Technology sub-scale of the QUEST validated questionnaire (the Quebec User Assessment of Satisfaction with assistive Technology), number of breakdowns, number of falls (if any) and time taken by the distributor to repair and provide a replacement wheelchair, if applicable.
Sufficient,for the following reasons: - benefit to overcome disability the expected increase in and independence for those with functional quadriplegia that is provided by TOPCHAIR-S, the powered wheelchair with stair-climbing capability. - the potential public health benefit, particularly as this need is currently not met.
People who are unable to operate a manual wheelchair by themselves, either because of their disability or because of an environmental situation which requires them to overcome obstacles, and who have the cognitive abilities that
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Factors determining the AB: - Technical specifications: - Conditions for prescription and use: - Contraindication:
enable them to use a powered wheelchair. TOPCHAIR-S is indicated for people whose educational, work and/or social lives require independent ambulation, including the ability to clear obstacles .
As the clinical data submitted in 2007 were limited, and as the post-inclusion study that was requested at the time of the first assessment has not yet been provided, though its protocol is currently being finalised, the Actual Benefit is granted on condition that the post-inclusion study that was requested by the Committee in 2007 be carried out. The CNEDiMTS will re-assess the actual benefit provided by TOPCHAIR-S in 3 years' time, based on the results of this study. Minimum technical specifications These are as described in the LPPR (list of reimbursed healthcare products & services) entry for TOPCHAIR-S: - TOPCHAIR-S must be equipped with an audible alarm device which instantly and automatically stops the wheelchair, if necessary, and with rear-view mirrors which can overcome a lack of visibility when travelling backwards (in particular, when going up steps). - The TOPCHAIR-S wheelchair is guaranteed for 2 years from date of delivery, with the exception of batteries and wheels, which are guaranteed for 1 year. The guarantee covers any manufacturing defects and defects in raw materials and components, under normal conditions of use. Procedures for prescription and use These are as described in the LPPR, i.e.: Reimbursement is subject to an interim agreement. Reimbursement is granted after a trial involving a multi-disciplinary team consisting of (as a minimum) a physical medicine and rehabilitation specialist physician, with the help of a physiotherapist or occupational therapist and after a certificate has been provided by this physician. This certificate: attests that this wheelchair is suitable for this person's disability; attests that the patient requires a stair-climbing wheelchair in order to participate in daily activities outside the home, and that the environment in which the person's daily life takes place contains obstacles; statescognitive abilities enable him/her to use this device that the person's appropriately. This trial should be carried out each time this wheelchair is provided for the first time, and if this is not the first wheelchair provided to the patient, the trial should be carried out only if the previous wheelchair was electrically powered but did not have a stair-climbing capability. The trial that should be carried out when this wheelchair is first provided should also involve a trial of a powered wheelchair without stair-climbing capability. The distributor will be required to provide a TOPCHAIR-S wheelchairfree of chargefor the duration of the trial. Reimbursement cannot be renewed within the first five years following purchase of the equipment. The Committee specifies that the trial must include a period during which the patient uses the device at home, and that this period must be sufficiently long in order to establish to what extent TOPCHAIR-S meets the needs of this patient's daily life and plans.
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Added clinical value (ACV): Type of inclusion on reimbursement list: Duration of inclusion:
Renewal conditions:
Target population:
TOPCHAIR-S is contraindicated for those weighing more than 110 kg. Substantial improvement in Added clinical value (level II) because of the lack of any alternative. Brand name
3 years
Renewal of inclusion is granted on condition that the study requested by the Committee at the time of the first assessment of TOPCHAIR-S is carried out. The objectives of this study are summarised below. The primary endpoint consists of: - use of the stair-climbing capability in daily social life outside the home which must be measured objectively. - increase in independence for the disabled person that results from use of the stair-climbing capability of TOPCHAIR-S, based on personal requirements. Three secondary endpoints are to be used: - Functionality:ease of use, ergonomics, length of time taken to learn to use. - of the TOPCHAIR-S wheelchair: safety in use (number of Reliability breakdowns, number of falls), and availability of wheelchair in case of breakdown (time taken by the distributor to provide a replacement wheelchair, time taken to repair wheelchair). -disabled person was planning to do with TOPCHAIR-S that the Activities but was unable to accomplish. A total follow-up period of 12 months after provision of TOPCHAIR-S, and two follow-up visits at 1 month and 6 months, are recommended. The study protocol that has been submitted to HAS by the applicant is currently being finalised. The applicant has chosen a comprehensive follow-up procedure. The final version of the protocol will need to be submitted to HAS. The manufacturer will need to provide annual information to HAS about the progress of the study. The annual target population is estimated to be between 50 and 100 people.
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Definitive opinion 1
EVIDENCE REVIEW
Nature of the application Application for renewed inclusion on the list of products and services qualifying for reimbursement (LPPR) mentioned under article L. 165-1 of the French Social Security Code. Request for an amendment to conditions for inclusion on the LPPR: increase maximum user weight from 75 kg to 110 kg. Models and references TOPCHAIR S. - Packaging Single unit. sApplication The application involves the following indication: overcoming disability for people with reduced mobility, whose lives involve negotiating steps, kerbs and/or significant slopes. - with a maximum weight of 110 kg; people
- people who have the cognitive ability to control a powered wheelchair. The current indication for TOPCHAIR-S on the LPPR: "People who are unable to operate a manual wheelchair by themselves, either because of their disability or because of an environmental situation which requires them to overcome obstacles, and who have the cognitive abilities that enable them to use a powered wheelchair. TOPCHAIR-S is indicated for people whose educational, work and/or social lives require independent ambulation, including the ability to clear obstacles. TOPCHAIR-S is designed for people with a maximum weight of 75 kg. " Reimbursement history This is the first request for renewed inclusion on the reimbursement list. TOPCHAIR-S was included on the LPPR by decree for the period 21 February 2008 to 31 January 2011, following the Committee's opinion dated 11 July 2007.
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Characteristics of the product and the associated service CE marking Class I, CE declaration of conformity by the manufacturer. ion riptDesc TOPCHAIR-S is a powered wheelchair with stair-climbing capability. It is designed for indoor and outdoor use. It is not foldable and cannot be disassembled. The main technical features of TOPCHAIR-S are as follows: - Total length with footrest: 115 cm - Width: 68 cm - Total height with Recaro seat: 128 cm - Empty weight with Recaro seat: 150 kg - Maximum speed on wheels: 9.2 km/h - Maximum speed on caterpillar tracks: 0.7 km/h - Distance between recharges on flat ground: between 38 and 45 km The settings on the control interface can be adjusted (maximum and minimum speeds, acceleration, deceleration etc). These settings are adjusted by the distributor in line with the user's wishes and abilities. Intended purpose TOPCHAIR-S has three movement settings: "road", "steps" and "caterpillar tracks". In "road" mode, power is sent to two sets of wheels (front and rear). In "steps" mode, the wheels are retracted and power is sent to caterpillar tracks. Rubber caterpillar tracks, strengthened with a steel frame, support the chair on the edge of the steps. "Caterpillar tracks" mode is used in certain situations, such as on an access ramp or on irregular, slippery or sloping ground. It cannot be used on stairs that are too steep, frozen or very slippery, or on spiral staircases. The automatic step detection and wheel retraction system uses information collected by remote infrared sensors. It therefore cannot be used on glass or openwork staircases, or steps that have a highly reflective surface. In such cases, the manual mode should be used. The maximum height of an obstacle or step is 20 cm. It has a range of 300 steps between recharges.
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Actual Benefit 1. Benefit of the product or service 1.1 Data analysis: assessment of the ratio of the positive effect of technological adaptations to overcome disability to the adverse effects, risks linked to use. 1.1.1. Summary of the opinion of the Committee dated 11 July 2007 This opinion was based on a single-centre, prospective, comparative, randomised crossover study involving 25 patients. This study, which was provided in an unpublished version in 2007, has since been published1.
The patients who were enrolled had functional quadriplegia of various causes and needed a powered wheelchair because of loss of ambulation associated with motor deficit of the upper limbs. The objective of this study was: · - to compare the performance of TOPCHAIR-S with that of the STORM3 wheelchair (a powered wheelchair that is commonly used by patients with quadriplegia). · toassess the stair-climbing capability of TOPCHAIR-S. - There was no significant difference in success rates for outdoor and indoor circuits and mean circuit completion times for STORM3 and TOPCHAIR-S. - 23 patients of 25 were able successfully and without help to clear a 20 cm step, simulating a kerb. Twenty of 25 patients successfully went up and down 6 steps on 2 occasions without help. The Committee has highlighted the innovative nature of TOPCHAIR-S. It declared that the expected benefit was sufficient, with a significant improvement in benefit (level II) because of the lack of any alternative. It was proposed that the device be included on the list for 3 years, with renewed inclusion conditional to a post-inclusion study, the objectives and duration of which were stated, and which are summarised below: "The primary endpoint consists of: - of the stair-climbing capability in daily social life outside the home which must be use measured objectively. -in independence for the disabled person that results from use of the stair-climbing increase capability of TOPCHAIR-S, based on personal requirements. Three secondary endpoints are to be used: - Functionality:ease of use, ergonomics, length of time taken to learn to use. - Reliability of the TOPCHAIR-S wheelchair: safety in use (number of breakdowns, number of falls), and availability of wheelchair in case of breakdown (time taken by the distributor to provide a replacement wheelchair, time taken to repair wheelchair). - that the disabled person was planning to do with TOPCHAIR-S but was unable to Activities accomplish. A total follow-up period of 12 months after provision of TOPCHAIR-S, and two follow-up visits at 1 month and 6 months, are recommended. "
1Guillon B. Assessment of a stair-climbing power wheelchair in 25 people with tetraplegia. Arch Phys Med Rehabil 2008; Laffont I, 89:1958-1964.
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1.1.2. New data A retrospective study of TOPCHAIR-S wheelchairs sold in France in 2009 and 2010 was provided by the applicant. This study used the assessment questionnaires that were proposed for the post-inclusion observational study, the protocol for which is currently being finalised. Eleven TOPCHAIR-S wheelchairs were sold for individual use and delivered to users during this period: 7 patients responded to the retrospective assessment; 3 patients were not using TOPCHAIR-S because of their state of health (readmission to hospital) and 1 patient could not be contacted. The endpoints were: - increase in independence for the user resulting from the stair-climbing capability, assessed using the Wheelchair Outcome Measure questionnaire (modified French-language version of the WhOM methodology); user satisfaction with TOPCHAIR-S, measured using the Device sub-scale of the QUEST -validated questionnaire (Quebec User Assessment of Satisfaction with assistive Technology); - number of breakdowns; - number of falls; - time taken by the distributor to repair wheelchair and provide a replacement wheelchair, if applicable. TOPCHAIR-S suited the lifestyles of all 7 patients, who were living independently. Four patients used TOPCHAIR-S at home and outside the home. The other 3 patients used TOPCHAIR-S exclusively outside the home. Results in independence: Increase Each user defined his/her objectives for participation, involving use of TOPCHAIR-S's stair-climbing capability or caterpillar tracks either at home or outside the home. For each of the 7 users, between 1 and 4 objectives for participation that were considered to be significant were defined. Each user considered that all his/her objectives for participation had been achieved. User satisfaction when carrying out these activities was assessed at between 8 and 10 (on a scale 0 = "not at all satisfied" to 10 = "extremely satisfied"). User satisfaction with assistive technology (QUEST): only raw data are reported. There is no summary of these results. Number of falls: 0 of breakdowns: Number - 3 breakdowns declared by a single user; 1 breakdown (electrical leads stuck in the back) for a 2nd user; -- 1 breakdown (rear wheels stuck) for a 3rd user; - 1 breakdown (wheels vibrated too much) for a 4th user. Recorded breakdowns: For the first 2 users, the wheelchair remained available during repairs. For the 3rd user, the wheelchair was not available for the whole repair period, but the timescale was not specified. In the last case, the wheelchair remained available during the repair period, but this was judged by the patient to be quite long. The new data that have been provided since the previous assessment do not meet the Committee's expectations, in particular given the small number of patients who have benefited from this technology since it was added to the list of reimbursed products.
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Healthcare professionals have identified the difficulties in making TOPCHAIR-S wheelchairs available in rehabilitation centres as a factor that is responsible for the slow spread in use of this device. 1.2 Role in strategies for overcoming disability
There are currently no alternatives that enable those with functional quadriplegia to clear obstacles, go up and down stairs and cover uneven ground without assistance. People with functional quadriplegia usually use powered wheelchairs. Wheelchairs, whether manually or electrically powered, are perceived as being the primary cause of limitation of activity for those with spinal cord injury who are paraplegic or quadriplegic2. Users of powered wheelchairs, despite technological progress and ongoing progress in the area of accessibility3, still have limited independence in some situations4: steps and stairs, pavements and crossing thresholds, in particular. Some devices that can overcome these obstacles and climb up and down stairs have been developed over the last fifteen years5. The most commonly used of such devices are elevating platforms and movable systems that have to be moved by a third party. These do not enable the disabled person to move around independently. Several powered wheelchairs with stair-climbing functions have been developed in various countries since 2000: Galileo (Israel), IBOT 40006,7 (USA), the TGR Explorer (Italy) and TOPCHAIR-S (France). TOPCHAIR-S is the only wheelchair that can autonomously go up or down several steps and scale obstacles (such as a kerb up to 20 cm in height) that is available in France. TOPCHAIR-S is designed to overcome motor disability in those with functional quadriplegia who wish to live more independently and to make it easier for such people to integrate/reintegrate into society. TOPCHAIR-S is not a substitute for adjustments to the environment that are designed to facilitate access to public places and to social, educational and work life for those with motor disabilities. In conclusion, given the data provided, and considering the expected increase in independence, the Commission considers that: TOPCHAIR-S is the only wheelchair available on the French market that offers the possibility of climbing stairs and clearing obstacles without aid from a third party. of overcoming disability for those with functionalTOPCHAIR-S offers a benefit in terms quadriplegia who are eligible for a powered wheelchair and whose daily life outside the home and environmental circumstances require them to clear obstacles. 2. Public health benefit 2.1 Seriousness of the condition Many different conditions, with various aetiologies, can lead to functional quadriplegia (severe neuromotor damage to all four limbs): examples include myopathy, traumatic quadriplegia due to spinal cord injury, head injury, stroke, degenerative diseases (e.g. multiple sclerosis), cerebral palsy, the sequelae of poliomyelitis.
2 ES, Boninger ML, Cooper R, Fitzgerald SG, Gray DB, Cooper RA. Assessing the influence of wheelchair technology on Chaves perception of participation in spinal cord injury. Arch Phys Med Rehabil. 2004; 85: 1854-8 3Cooper RA. Engineering manual and electric powered wheelchairs. Crit Rev Biomed Eng. 1999; 27: 27-73 4Brandt A, Iwarsson S, Stahle A. Older people's use of powered wheelchairs for activity and participation. J Rehabil Med. 2004 Mar; 36 (2): 70-7 5 MJ, Ishimatsu T. Modeling of Lawna stair-climbing wheelchair mechanism with high singlestep capability. IEEE Trans Neural Syst 6: 3)3-32; ep (1102 .S 30libagnE 2h3eR C oo per RA, Boninger ML, Cooper R, Fitzgerald SG, Kellerher A. Preliminary assessment of a prototype advanced mobility device in the work environment of veterans with spinal cord injury. NeuroRehabilitation. 2004; 19(2): 161-70 7 UustalMinkel JL. Study of the independence IBOT 3000 mobility system: an innovative power mobility device, during use in H, community environment. Arch Phys Med Rehabil 2004; 85: 2002-2010 - 8 -
Functional quadriplegia often leads to a loss of ambulation. This disability causes a significant reduction in quality of life and independence in comparison with a non-disabled person, and its psychological and organisational impact is significant. 2.2 Epidemiology of the condition The Lecomte report8 the lack of reliable epidemiological data about the number of underlined disabled people, types of disability, degree of seriousness and origin of the disability. According to the Lecomte report, the French market for vehicles for disabled people was estimated to be 90,000 units in 2001, 4.9% of which were indoor powered wheelchairs and 1.8% outdoor powered wheelchairs (in total, 6.8% of the wheelchair market was represented by powered wheelchairs). The working group "Vehicles for disabled people", which was set up by the Committee, considered in May 2003 that 100,000 vehicles for disabled people are sold each year in France, of which 7% are powered wheelchairs. The population of people with quadriplegia in France is around 35,000, with an incidence of 500-800 cases per year. 2.3 Impact TOPCHAIR-S meets an unmet need in the field of overcoming disability. Overall, the Committee considers that TOPCHAIR-S has the potential to benefit public health. In conclusion, and given the fact that the post-inclusion study requested by the Committee in 2007 is being established, the National Committee for the Evaluation of Medical Devices and Health Technologies considers that the Actual Benefit of the powered wheelchair with stair-climbing capability TOPCHAIR-S is sufficient for it to be included on the list of reimbursable products and services mentioned under article L.165-1 in the indication: "People who are unable to operate a manual wheelchair by themselves, either because of their disability or because of an environmental situation which requires them to overcome obstacles, and who have the cognitive abilities that enable them to use a powered wheelchair. TOPCHAIR-S is indicated for people whose educational, work and/or social lives require independent ambulation, including the ability to clear obstacles. "
8Lecomte Report. Aides techniques [Assistive technology]. Situation actuelle, données économiques, proposition de classification et de prise en charge [Current situation, economic data, proposed classification and management]. March 2003 - 9 -
Factors determining the Actual Benefit As the clinical data submitted in 2007 were limited, and as the post-inclusion study that was requested at the time of the first assessment has not yet been provided, though its protocol is currently being finalised, the Actual Benefit is granted on condition that the post-inclusion study that was requested by the Committee in 2007 be carried out. The CNEDiMTS will re-assess the actual benefit provided by TOPCHAIR-S in 3 years' time, based on the results of this study. Minimum technical specifications These are as described in the LPPR (list of reimbursed healthcare products & services) entry for TOPCHAIR-S: - TOPCHAIR-S must be equipped with an audible alarm device which instantly and automatically stops the wheelchair, if necessary, and with rear-view mirrors which can overcome a lack of visibility when travelling backwards (in particular, when going up steps). - TOPCHAIR-S wheelchair is guaranteed for 2 years from date of delivery, with the exception The of batteries and wheels, which are guaranteed for 1 year. The guarantee covers any manufacturing defects and defects in raw materials and components, under normal conditions of use. Conditions for prescription and use These are as described in the LPPR, i.e.: Reimbursement is subject to an interim agreement. Reimbursement is granted after a trial involving a multi-disciplinary team consisting of (as a minimum) a physical medicine and rehabilitation specialist physician, with the help of a physiotherapist or occupational therapist and after a certificate has been provided by this physician. This certificate: attests that this wheelchair is suitable for this person's disability; attests that the patient requires a stair-climbing wheelchair in order to participate in daily activities outside the home, and that the environment in which the person's daily life takes place contains obstacles; states that the person's cognitive abilities enable him/her to use this device appropriately. This trial should be carried out each time this wheelchair is provided for the first time, and if this is not the first wheelchair provided to the patient, the trial should be carried out only if the previous wheelchair was electrically powered but did not have a stair-climbing capability. The trial that should be carried out when this wheelchair is first provided should also involve a trial of a power wheelchair without stair-climbing capability. The distributor will be required to provide a TOPCHAIR-S wheelchairfree of charge the for duration of the trial. Reimbursement cannot be renewed within the first five years following purchase of the equipment. TOPCHAIR-S is contraindicated for those weighing more than 110 kg. The Committee specifies that the trial must include a period during which the patient uses the device at home, and that this period must be sufficiently long in order to establish to what extent TOPCHAIR-S meets the needs of this patient's daily life and plans. Added clinical value (ACV) In the absence of a comparator device, and given the expected increase in independence, the Committee has stated that the powered wheelchair with stair-climbing capability TOPCHAIR-S provides a substantial Improvement in Added clinical value (level II).
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Renewal conditions and duration of inclusion Renewal conditions: Renewal of inclusion is granted on condition that the study requested by the Committee at the time of the first assessment of TOPCHAIR-S is carried out. The objectives of this study are summarised below. The primary endpoint consists of: -stair-climbing capability in daily social life outside the home which must be use of the measured objectively. - increasein independence for the disabled person that results from use of the stair-climbing capability of TOPCHAIR-S, based on personal requirements. Three secondary endpoints are to be used: -ease of use, ergonomics, length of time taken to learn to use. Functionality: -TOPCHAIR-S wheelchair: safety in use (number of breakdowns, number of Reliability of the falls), and availability of wheelchair in case of breakdown (time taken by the distributor to provide a replacement wheelchair, time taken to repair wheelchair). - that the disabled person was planning to do with TOPCHAIR-S but was unable to Activities accomplish. A total follow-up period of 12 months after provision of TOPCHAIR-S, and two follow-up visits at 1 month and 6 months, are recommended. The study protocol that has been submitted to HAS by the applicant has not yet been validated. The applicant has chosen to carry out comprehensive follow-up for only the first 100 patients. The final version of the protocol will need to be submitted to HAS before the study begins. The manufacturer will need to provide annual information to HAS about the progress of the study. Proposed duration of inclusion: 3 years Target Population
The population of people with quadriplegia in France is around 35,000, with an incidence of 500-800 cases per year. The population of people with functional quadriplegia in France cannot be calculated. According to figures from the National Health Insurance scheme (CNAM), 7200 powered wheelchairs were reimbursed under the general regime in 2006. Some users of powered wheelchairs are not suitable for TOPCHAIR-S: those who live in a completely adapted environment, whose lives do not require them to clear obstacles, those who lack the cognitive abilities necessary to use this wheelchair, those who are very elderly or who weigh more than 110 kg. Given these restrictions and considering expert opinion, the annual target population can be estimated at between 50 and 100 people.
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