Clinical and technical evidence

Advice

Published evidence
Overall assessment of the evidence
Recent and ongoing studies

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

The evidence for RT300 includes 17 studies, of which 6 relevant studies (3 randomised trials and 3 before–after cohort studies) that reported key outcomes (such as secondary complications and quality of life) are summarised in this briefing. Table 2 summarises the clinical evidence as well as its strengths and limitations.

Overall assessment of the evidence

The evidence for the effectiveness of the RT300 functional electrical stimulation (FES) cycling in people with spinal cord injuries is limited, with outcomes only reported for a total of 43 adults and 60 children.

The available evidence is from 2 randomised studies in children, 1 randomised trial and 3 before–after observational studies in adults. All 6 studies were done in the US and Canada, which may limit the generalisability of the results to NHS settings.

Two randomised controlled trials were based on the same cohort of children with spinal cord injury. They showed that there was a statistically significant increase in lower limb muscle volume and muscle strength but no change in bone mineral density after the 6-month FES cycling (Johnston et al. 2011, Lauer et al. 2011). One randomised trial involved adults with spinal cord injury and also showed a statistically significant increase in lower limb muscle volume (Johnston et al. 2016).

Three observational studies of adults with spinal cord injury showed a statistically significant improvement in lower limb exercise performance compared with baseline (Allison et al. 2016) but a non-significant change in upper limb exercise performance (Ptasinski et al. 2013) after the 12‑weeks FES cycling. The studies also suggest that RT300 FES cycling is associated with a statistically significant improvement in quality of life (Dolbow et al. 2013) and cardiovascular function (Ptasinski et al. 2013; Allison et al. 2016) compared with pre-treatment baseline.

Table 2 Summary of selected studies

Allison et al. 2016
Study size, design and location	A before–after cohort study of 10 adults with SCI for more than 6 months. Canada.
Intervention and comparator(s)	Intervention: RT300 FES-LE cycle (FES system for legs and core muscles) 3 times per week. No comparator.
Key outcomes	All patients experienced improvement in exercise performance because they were able to exercise for a longer distance before experiencing fatigue and needing fewer breaks after the 12-week FES cycling (p<0.01). There was a statistically significant increase in peripheral cardiovascular function, with a 34% increase in pulse volume within the femoral artery from an average of pre-intervention 4.25 ml to 5.69 ml (p=0.04). No changes in any molecular indices of cardiovascular risk such as cholesterol measures were seen.
Strengths and limitations	The study included adults (age ranged 26 to 55 years) with chronic SCI but this was a very small sample size (n=10). All patients had SCI with levels ranging from C5 to T11, and time since injury ranged from 6 months to 20 years.
Johnston et al. 2016
Study size, design and location	A randomised pilot study of 17 adults with SCI for more than 6 months. USA.
Intervention and comparator(s)	Intervention: RT300 FES cycle (FES system for legs and core muscles), low cadence cycling at 20 RPM (n=9). Comparator: RT300 FES cycle (FES system for legs and core muscles), high cadence cycling at 50 RPM (n=8).
Key outcomes	After the 6-month programme, both low and high cadence groups increased muscle volume compared with the baseline (low cadence cycling by 19%, p<0.01; high cadence cycling by 10%, p=0.56). Low cadence cycling showed a statistically significant decrease in bone-specific alkaline phosphatase, suggesting less bone formation after 6 months (15.5% decrease for low cadence cycling, p=0.04; 10.7% increase for high cadence cycling, p=0.74). Low cadence cycling group also had statistically significantly less bone resorption compared with the baseline (34.5% decrease for low cadence cycling, p=0.04; 16.7% decrease for high cadence cycling, p=0.34).
Strengths and limitations	The study recruited a total of 17 people with SCI, and 15 people completed the study. All patients had the intervention. There was no non-intervention control in the study.
Dolbow et al. 2013
Study size, design and location	A before–after cohort study of 11 male adults with SCI for more than 6 months. USA.
Intervention and comparator(s)	Intervention: RT300 FES-LE cycle (FES system for legs and core muscles). No comparator.
Key outcomes	There was an increase in all World Health Organisation QOL scores including physical, psychological, social, and environmental domains, with the physical and environmental domains sustaining a statistically significant increase. Physical QOL scores increased by 2.3 units (p=0.01) and the environmental QOL scores increased by 1.9 units (p=0.03) from before to after the programme.
Strengths and limitations	Only a small number of people were recruited to take part in the study, and there were no female patients.
Ptasinski et al. 2013
Study size, design and location	A before–after pilot study of 5 adults with SCI for more than 1 year. Canada.
Intervention and comparator(s)	Intervention: RT300 FES-arm ergometry (FES system for arms and core muscles). No comparator.
Key outcomes	There was a statistically significant decrease in resting MAP from 91.1 mmHg at the baseline to 87.7 mmHg following the 12-week FES cycling programme, but there was no change in resting heart rate. There were no statistically significant changes in exercise performance but a trend towards improvement in both time to fatigue and distance to fatigue after the programme.
Strengths and limitations	This is a pilot study that only included 5 patients. Functional outcomes were collected using a self-reported questionnaire.
Johnston et al. 2011
Study size, design and location	A prospective RCT of 30 children aged between 5 to 13 years with SCI. USA.
Intervention and comparator(s)	Intervention: RT300-P FES cycle (FES). Comparator: RT100 motorised cycle (PC) or a 2-channel surface stimulation unit to create lower limb muscle contractions (ES).
Key outcomes	There were statistically significant improvements in overall quadriceps muscle volume (24.4%, p=0.001) and muscle strength (42.4%, p<0.001) in FES groups after the 6-month intervention. Of 3 interventions, the ES group (27.2%) gained statistically significantly more in quadriceps muscle volume compared with the FES (24.4%, p=0.042) and PC (7.7%, p=0.001) groups. The FES (142.4%) gained statistically significantly more strength than the PC group (41.8%, p=0.015).
Strengths and limitations	Patients were randomised. All 30 children who took part in the study completed the training, with 24 having muscle volume data and 27 having stimulated strength data. There were statistically significant differences between groups in characteristics baseline including height, weight, and age, with more older and larger children in the ES group, and there were more patients with tetraplegia in the PC group compared with the FES and ES groups. But there was no difference between groups for outcome measures at baseline. The study did not define the minimally clinically important difference, so the changes seen may or may not be clinically meaningful in practice.
Lauer et al. 2011
Study size, design and location	A prospective RCT of 30 children aged between 5 to 13 years with SCI. USA.
Intervention and comparator(s)	Intervention: RT300-P FES cycle (FES). Comparator: RT100 motorised cycle (PC) or a 2-channel surface stimulation unit to create low limb muscle contractions (electrically stimulated exercise, ES).
Key outcomes	There were no statistically significant increases in BMD between or within intervention groups after 6 months.
Strengths and limitations	Patients were randomised. 28 of 30 children who took part in the study completed baseline and 6-month assessment. The developmental changes in BMD for children with SCI are not known.
Abbreviations: BMD, bone mineral density; ES, electrical stimulation; FES, functional electrical stimulation; MAP, mean arterial blood pressure; PC, passive cycling; QOL, quality of life; RCT, randomised controlled trial; RPM, revolutions per minute; SCI, spinal cord injury.

Recent and ongoing studies

No recent or ongoing studies were identified.