GaitSmart rehabilitation exercise programme for gait and mobility issues

The relevant clinical evidence suggested that GaitSmart improved gait and patient-reported outcomes in people at risk of falls. This included improvement in fear of falling, frailty and fitness, and health-related quality of life. The clinical experts and patient survey also reported benefits with GaitSmart in helping people to improve their gait and mobility issues. Reported benefits included better understanding of gait and mobility issues, more independence and confidence, and improvement in daily activities such as walking. The committee considered the evidence to be generalisable to the NHS, but there was no clinical evidence comparing GaitSmart with standard care in people at risk of falls. The committee concluded that GaitSmart showed enough benefits to be used to treat gait and mobility issues in people at risk of falls while more evidence is generated to address these gaps.

The committee considered that there was limited clinical-effectiveness evidence on GaitSmart in people having hip and knee replacements. The randomised controlled trial (McNamara et al. 2023) showed potentially greater improvements in people with hip or knee replacements who used GaitSmart after surgery. But differences in effectiveness between GaitSmart and standard care were not formally analysed. This study included a relatively small sample size and there was no evidence on using GaitSmart preoperatively. The committee concluded that the limited clinical evidence showed that GaitSmart may have the potential to improve gait outcomes in people having hip or knee replacements. But it thought more comparative studies are needed with larger sample sizes.

The committee considered that the included clinical studies did not report on outcomes for adherence to the GaitSmart rehabilitation exercise programme. The clinical evidence reported adherence as the proportion of people who completed the required assessment sessions, which ranged from 3 to 4 sessions (Hodgins and Newby 2023a, 2023b). 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 wider evidence base 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 exercise programme and how patient motivation is related to clinical outcomes.

GaitSmart would provide another treatment option for gait and mobility issues in people at risk of falls, or people having hip or knee replacements. The clinical experts advised that GaitSmart may fill a treatment gap for some people who may otherwise not be able to access gait rehabilitation services. 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 advised that the standard-care pathway is highly variable, and that people may be offered different treatments in line with their individual needs and preferences. The committee considered that some people may have complex problems and comorbidities that need more than 1 intervention. 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 visual gait assessments. The committee concluded that GaitSmart would be an alternative to standard-care gait assessment and exercise rehabilitation programmes. But some people may have a combination of treatments in line with their individual treatment plan and needs.

The committee discussed selecting people for treatment with GaitSmart in clinical practice. It also considered 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. In clinical practice, people may not be offered GaitSmart if they have a vestibular problem or complex medical history that needs physiotherapy, or are unable to walk 10 strides. GaitSmart may also not be suitable for people with moderate to severe cognitive impairment that affects their ability to follow the programme. The clinical experts 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. Treatment options should be discussed with patients, and should consider their individual needs and preferences. Healthcare professionals should present information clearly using language that is easy to understand. People should be offered standard care if GaitSmart is not suitable, or if face-to-face or group interventions are preferred.

The committee considered that GaitSmart is intended to be delivered by healthcare assistants, who would do the gait assessment and demonstrate the rehabilitation exercise programme. The clinical experts advised that most services would have a triage process with a physiotherapist, who would determine if a person should be offered GaitSmart or another treatment option. Once someone is referred for GaitSmart, a trained healthcare assistant would carry out the gait assessment and explain the exercise programme. GaitSmart is also being piloted as part of GP health checks, in which a healthcare assistant does the assessment without physiotherapist triage. The clinical experts noted that the healthcare assistants would be appropriately trained and supervised to use GaitSmart. The integrated vGym programme automatically selects the exercises in the personalised rehabilitation programme, so there is no need for exercise prescribing by a physiotherapist. Services should have a clear pathway to escalate any issues to a qualified physiotherapist if needed. The committee considered that people should also have the option to be referred to physiotherapy if preferred.

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 for 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 EAG advised that there was no evidence on the impact of GaitSmart on waiting lists, and that this was not included in the economic modelling. The committee concluded that further information is needed on how GaitSmart may affect physiotherapy waiting lists, and how this affects clinical and resource outcomes by enabling earlier access to treatment.

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

• £80.39 for people having hip or knee replacements

• £28.70 for people at risk of falls.

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. Injurious falls are associated with a significant impact for patients and the NHS. But 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 models 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 higher than the cost of GaitSmart.

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 costs of standard care 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. For people having hip or knee replacements, the committee considered that 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 when physiotherapy is not currently offered to everyone eligible for it. The committee also noted that cost savings with GaitSmart would be highly dependent on the grade of the staff delivering it, and how long the GaitSmart assessment takes. So, it concluded that cost savings may not be realised in clinical practice if use varied from that in the economic models.

The committee said that more evidence is needed on GaitSmart to support the benefits shown in the current clinical evidence. The clinical experts said that there are several ongoing or planned pilots evaluating the use of GaitSmart in the NHS in people at risk of falls. These include use in a range of settings, including a GP surgery, frailty clinic, care home and falls team. The committee considered that these real-world evaluations could address some of the uncertainties in the evidence outlined in the assessment for using GaitSmart in people at risk of falls. It concluded that there was enough evidence of benefits in this population for GaitSmart to be used in the NHS while this evidence is generated.

The committee said that larger comparative studies are needed to determine the clinical effectiveness of GaitSmart compared with standard care alone in people having hip or knee replacements. It noted that, at the time of the committee meeting, there were no ongoing real-world evaluations in this population. The most relevant clinical studies should be peer reviewed and published in the public domain.

For both populations, further evidence and research should clearly outline:

• the inclusion criteria

• place in the treatment pathway

• any other interventions that people had before or during the GaitSmart programme.
  
  The committee agreed that longer-term outcomes of around 3 to 6 months should also be reported, including gait outcomes, patient-reported outcome measures, adverse events and adherence rates. Evidence of the impact of GaitSmart on waiting lists would also be useful to show any additional clinical and system benefits not captured in the existing evidence base. The committee encouraged that any future evidence and research should be disseminated when available.