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Certificates

Системата има множество сертификати и се превръща в стандарт при лечението на състояния на централна нервна система, водещи до пареза на стъпалото.

Системата се използва в западна Европа - Великобритания, Португалия, Испания, Холандия, Белгия, Франция, Германия и други европейски държави. Изключително се е наложило като терапия в САЩ, Канада, Австралия, Европа.

Системата има следните сертификати за качество:

  • CE Certification
  • ISO13485
  • CFDA Approval
  • FDA Approval

Национален институт за високи стандарти в здравеопазването - Великобритания

Присъства в световни гайдлайни за лечение на Инсулт, Множествена склероза, ДЦП и други централни увреди.

1 Guidance

    1 Guidance

    1.1 Current evidence on the safety and efficacy (in terms of improving gait) of functional electrical stimulation (FES) for drop foot of central neurological origin appears adequate to support the use of this procedure provided that normal arrangements are in place for clinical governance, consent and audit.

    1.2 Patient selection for implantable FES for drop foot of central neurological origin should involve a multidisciplinary team specialising in rehabilitation.

    1.3 Further publication on the efficacy of FES would be useful, specifically including patient-reported outcomes, such as quality of life and activities of daily living, and these outcomes should be examined in different ethnic and socioeconomic groups.

    Efficacy A meta-analysis of three studies on skin surface-applied FES found that it increased gait speed by a mean difference of 0.18 metres /second  (95% CI 0.08 to 0.28) in stroke patients (n = 36) compared with conventional therapy (n = 35) (absolute numbers not given). When evidence was considered from all studies (three controlled trials and two non-controlled trials) the mean effect size ranged from - 0.11 to 1.431. In a case series of 140 patients undergoing skin surface FES, stroke patients (n = 111) showed an increase in walking speed of 12% (0.07metres/second) and a decrease in effort of 18% (-0.16 beats/metre) (measured by a physiological cost index) when using the stimulator (orthotic effect) compared with baseline. At 4.5-month follow-up there was a 14% (0.08 metres/second) increase in walking speed and a 19% (-0.17 metres/second) reduction in effort. In patients with multiple sclerosis (n = 21) there was a 16% (0.08 metres/second) increase in walking speed and a 24% (-0.20 beats/metre) decrease in effort. However, when not using the stimulator the patients reported a 7% (-0.03 metres/second) decrease in walking speed and a 16% (0.13 beats/metre) increase in effort2. 
     
    Two randomised controlled trials reported on efficacy outcomes following implantation of electrodes6, 4. In the first trial FES was compared with conventional therapy in 29 patients. FES resulted in a 23% improvement in walking speed measured with the six-minute walking test (6MWT), compared with an improvement in the control group of 3% (p = 0.010).Comfortable
    IP overview: functional electrical stimulation for spasticity of the foot   page 3 of 29
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    walking speed measured on a 10-metre walkway was also significantly improved in the FES group (p = 0.038)6. In the second randomised controlled trial no significant differences in the 6MWT were found between the group with implanted electrodes (post-treatment mean/median walking distance 252.2 metres) and the control group who received physiotherapy training (post-treatment mean/median walking distance 165.9 metres; p = 0.184). The primary outcome measure in this study was gait component execution according to the Tinetti gait scale, a 12-point scale assessing gait components such as gait initiations, walking path and trunk alignment. The FES group had a statistically significant greater gain versus the control group for gait component execution (p = 0.003; parameter estimate 2.9, 95% CI 1.2 to 4.6). Around 50% of the control group had no gains, whereas 14% of the FES group had no gains4. Both groups subjectively reported gains in walking endurance and functional milestones. Functional milestones were reported in 11 instances (such as prepared dinner’, ‘walked outside’) for the control group and 53 instances for the FES group. Milestones of greater motor complexity were demonstrated more frequently in the FES group than in the control group.

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