Advice
Clinical and technical evidence
Clinical and technical evidence
A literature search was carried out for this briefing in accordance with the interim process and methods statement. This briefing includes the most relevant or best available published evidence relating to the clinical effectiveness of the technology. Further information about how the evidence for this briefing was selected is available on request by contacting mibs@nice.org.uk.
Published evidence
One case report and 2 observational pilot studies including a total of 21 people with Parkinson's disease and freezing of gait symptoms are summarised in this briefing. Table 2 summarises the clinical evidence as well as its strengths and limitations.
Overall assessment of the evidence
The preliminary evidence from the 2 included pilot studies suggests that Path Finder has the potential to reduce freezing of gait and the risk of falls in patients with Parkinson's disease. However, available evidence for the benefits of Path Finder in the NHS is limited by the low quality of relatively small studies all from outside of the UK from a single centre, so there is no comparative study to NHS standard practice. Also, there are no published comparative studies on the use of the technology compared with other visual-cueing devices which may be replaced by this device. Additional outcomes, such as the effect of the technology on the number of falls caused by freezing of gait and associated emergency visits, the number of physiotherapy sessions and patients' overall quality of life, could provide information on the long-term benefits of the technology for both the patient and healthcare system.
Table 2 Summary of selected studies
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Study size, design and location |
Observational before-and-after study involving 21 people with Parkinson's disease and a recent history of regular and disabling freezing of gait, done in a controlled gait laboratory in the Netherlands. |
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Intervention and comparator(s) |
Intervention: Path Finder laser shoe. No comparator. |
|
Key outcomes |
2 patients were excluded from the analysis; 1 for inability to see the laser and 1 because freezing of gait episodes could not be quantified. The use of Path Finder was associated with statistically significant reductions in the number of freezing of gait episodes, both 'off' (45.9% reduction; p=0.007) and 'on' (37.7% reduction; p=0.028) medication. Path Finder reduced the percentage of time spent frozen by 56.5% 'off' medication (p=0.004) and by 51.4% 'on' medication (not significant; p=0.075). Path Finder resulted in a small increase in double arm support time when in the 'on' medication phase. No significant changes were seen in any of the other the gait measures recorded using accelerometry. None of the patients reported worsening of their gait and most subjectively reported positive experiences. |
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Strengths and limitations |
Study was a non-UK pilot study with a small number of patients and no comparator. The study did not take into consideration previous experience of patients with cueing, the assessor was not blinded to the cueing condition and the study was limited by the lack of adjustment for multiple comparisons in post hoc analyses. It was done in a controlled gait laboratory, so results may not be generalisable to the home setting. |
|
Study size, design and location |
Open-label before-and-after pilot study involving the same 21 people with Parkinson's disease and severe freezing of gait from Barthel et al. (2018a), done in a home setting in the Netherlands. |
|
Intervention and comparator(s) |
Intervention: Path Finder laser shoe. No comparator. |
|
Key outcomes |
Path Finder was associated with statistically significant improvements in freezing of gait severity (p=0.036), with no correlation with cognitive status (Frontal Assessment Battery). The technology was associated with a 41%, 58% and 31% reduction in self-reported falls, near falls and freezing of gait episodes, respectively. Patients reported positive subjective experiences on the efficacy of the technology. |
|
Strengths and limitations |
The study was done in a home setting, providing evidence in a real-world environment. It was done over a period of 3 weeks, involving a baseline week (wearing the device but without cueing), a test week and a follow-up week (without device). No patient demographics or information on the level of compliance was provided and there was limited information methodology. The lack of a passive or active control means the effect of a placebo effect cannot be ruled out. |
|
Study size, design and location |
Case report of a 79-year-old man with 12-year history of Parkinson's disease and clinical presentation that includes severe freezing of gait and falls. |
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Intervention and comparator(s) |
Intervention: Path Finder laser shoe. No comparator. |
|
Key outcomes |
Video evidence from this case report showed that use of the technology while the user was taking chronic dopaminergic medication helped normalise gait pattern and reduce freezing in the patient. This improvement extended to the home setting where the patient was allowed to use the technology for 1 week. |
|
Strengths and limitations |
This case report provides low-level evidence and reported outcomes are from 1 patient only, lacking generalisability. No quantitative measures were made. The first author designed and developed the technology. |