GaitSmart rehabilitation exercise programme for gait and mobility issues

The limited clinical evidence suggests that GaitSmart may have the potential to improve gait outcomes, but further evidence is needed

4.1 The committee considered that the clinical evidence available is generalisable to the NHS setting. But the available studies included relatively small populations. The committee also noted that the most relevant studies are not published in the public domain, although the randomised controlled trial by McNamara has been submitted for publication. The clinical experts explained that the outcomes used to measure the effectiveness of GaitSmart are validated tools for measuring patient-reported outcomes and function. So, consideration was given to the clinical significance of results. No adverse events were recorded in any of the studies. The committee concluded that the limited clinical evidence showed that GaitSmart may have the potential to improve gait outcomes in people at risk of falls and people having hip or knee replacements. But it thought that larger comparative studies are needed.

More evidence is needed on adherence to the GaitSmart intervention and drop-out rates

4.2 The committee considered that the included clinical studies had relatively short follow-up times. It also noted that they did not report on outcomes for adherence to the GaitSmart programme. The clinical experts explained that people with gait and mobility issues need about 12 weeks of rehabilitation to have improvement in gait outcomes. They also said that the published evidence on people with gait and mobility issues showed that adherence to exercise programmes is essential for improvements in patient-reported outcomes. The committee concluded that additional evidence is needed about adherence to the GaitSmart programme and how patient motivation is related to clinical outcomes.

A clear description of patient populations is lacking in the available clinical evidence

4.3 The external assessment group (EAG) explained that the included clinical studies did not clearly outline the inclusion criteria for participants or the interventions that they had had before having a GaitSmart assessment. The committee noted that it was important for the clinical evidence to reflect the expected treatment pathway for people in clinical practice. The committee concluded that additional evidence should include clear details on who was recruited, and on the other interventions that they had had before or during the GaitSmart programme.

GaitSmart is expected to be used in addition to standard care for people with gait and mobility issues

4.4 The EAG explained that the included studies had a high degree of heterogeneity in terms of the comparators that were included for control groups. The clinical experts explained that, in clinical practice, people at risk of falls would usually have one-to-one physiotherapy after a falls incident. They also explained that people having rehabilitation after a hip or knee replacement would be offered group physiotherapy sessions. In addition, people having hip or knee replacements have regular visual gait assessments. The committee also had input from a patient expert. This suggested that some people would prefer a combination of GaitSmart and group physiotherapy. The committee noted that the GaitSmart programme consists of 4 sessions lasting between 9 and 24 weeks in total. With this in mind, it concluded that the most appropriate place for GaitSmart in the clinical pathway would be as an adjunct to standard care.

People at risk of falls should be assessed for eligibility for treatment with GaitSmart, and patience choice should be considered

4.5 The committee discussed selecting people for treatment with GaitSmart in clinical practice. It also took into account that some people may have gait and mobility issues that are not related to muscle weakness. The clinical experts advised that, according to published evidence, 80% to 90% of falls are in people with muscle weakness. They also said that some people may prefer group physiotherapy sessions rather than a personalised rehabilitation exercise programme that is intended to be completed at home. The committee concluded that all people considered for treatment with GaitSmart would need to be screened for other underlying causes such as neurological impairment. It added that patient choice should be a significant consideration for using GaitSmart as an intervention if it is adopted into clinical practice.

The impact of GaitSmart on physiotherapy waiting lists and any subsequent impact on patient wellbeing should be considered

4.6 The committee discussed the potential impact of GaitSmart on physiotherapy waiting lists in the NHS for relevant populations. People may experience deterioration in outcomes related to wellbeing and ability to complete daily activities while waiting to have treatment. The clinical experts explained that GaitSmart may offer an alternative treatment option for people who are on physiotherapy waiting lists. This has the potential to improve patient outcomes. But it may lead to an increase in healthcare costs for people who would otherwise not have any intervention. The committee concluded that further information is needed on how GaitSmart may affect physiotherapy waiting lists and how this affects patient wellbeing by enabling access to treatment.

Patients commented on the ability of GaitSmart to help monitor progress with the support of a healthcare professional

4.7 The patient expert said that the most beneficial aspect of a GaitSmart assessment was being able to track progress using objective measures. They also found the personalised exercise programme to be useful, and stated that the exercises were similar to those done in physiotherapy. The patient expert found some aspects of the GaitSmart report difficult to interpret. But they acknowledged that they had support from the healthcare professional at each session to help them understand the report. It was noted that video representations of each exercise, in addition to the exercise descriptions and photos already included, would improve the intervention. They added that they had no issues with access to GaitSmart or the convenience of the assessments, which took place in a designated centre at the local hospital.

The EAG's updated model is plausible and appropriate for decision making, and GaitSmart is cost saving compared with standard care

4.8 The committee considered that the EAG's base-case model was appropriate for decision making, and agreed with the parameters included in the model. The clinical experts explained that the risk of falls calculated by the EAG was more realistic than that included in the company's model. It was noted that the reduction in falls because of GaitSmart had a relatively small impact in the economic model. The EAG's base-case model showed that GaitSmart was cost saving by:

The cost of the GaitSmart intervention and standard care are the key cost drivers in both economic models

4.9 The committee considered that the overall estimated cost saving with GaitSmart compared with standard care alone was dominated by the cost difference between the interventions. Falls are associated with a significant impact for patients and the NHS. Also, a marginal number of falls were prevented by GaitSmart, so the impact of falls in both models was limited. The committee concluded that the most important economic input in the model was the cost of the comparator. For GaitSmart to be cost neutral or cost saving, the cost of the comparator would need to be very close to or significantly higher than the cost of GaitSmart.

GaitSmart remains cost saving in the one-way sensitivity analyses but could be cost incurring depending on its and standard care costs

4.10 For people having hip or knee replacements, the committee considered that the all the EAG's one-way sensitivity analyses showed GaitSmart to be cost saving compared with standard care alone. This applied to the entire plausible range of values for each parameter that was explored. But the committee also commented that GaitSmart has the potential to increase costs for the NHS if used:

The committee also noted that cost savings with GaitSmart are highly dependent on the grade of the staff doing it, and how long the GaitSmart assessment takes. So, it concluded that cost savings may not be realised in clinical practice. For people at risk of falls, the EAG's sensitivity analyses varied the type of comparator used (either group or individual physiotherapy) and the associated staff time. The committee considered that GaitSmart was cost saving in most scenarios, but not when standard care was a small number of group physiotherapy sessions. The clinical experts explained that people who have a fall are expected to have one-to-one physiotherapy in clinical practice. So, the standard care costs are substantially higher than the cost of GaitSmart, which means the intervention is likely to be cost saving for people at risk of falls. The committee also agreed with the EAG's estimate that the point of cost neutrality for standard care is expected to be similar to the cost of the GaitSmart intervention.

Further research would help to determine the clinical effectiveness of GaitSmart and should include long-term outcomes data

4.11 The committee said that larger comparative studies are needed to determine the clinical efficacy of GaitSmart compared with standard care alone. It added that these studies should use GaitSmart as an adjunct to standard care because this is how it is expected to be used in clinical practice. It also said that inclusion criteria and place in the treatment pathway should be clearly outlined, and that the most relevant clinical studies should be peer reviewed and published in the public domain. The committee agreed that long-term outcomes should also be reported, including gait outcomes, patient-reported outcome measures and adherence rates.