Advice

Clinical and technical evidence

Clinical and technical evidence

A literature search was carried out for this briefing in accordance with the published 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

This briefing summarises the results of 1 systematic review and 5 case series including a total of 41 patients. Three of these case series were included in the systematic review and have been summarised separately in this briefing to highlight relevant outcome measures that were not reported in the systematic review.

Results indicated that Ekso enabled patients to stand, walk and sit with minimal assistance and using light to moderate effort. The increased mobility may have contributed to reduced pain, less muscle tightness, fewer involuntary movements, and improved bowel function in some patients.

One meta-analysis of a range of exoskeleton devices was also identified (Miller 2016). This included 14 studies of various exoskeleton devices, 3 of which included Ekso. The meta-analysis reported that across all studies 76% of patients were able to walk with an exoskeleton without physical assistance, and that patients had decreased spasticity and improved bowel movements. These results were not specific to Ekso and so this study has not been summarised in the evidence table.

Strengths and limitations of the evidence

The evidence base is currently very limited with outcomes only reported for 41 patients across 5 clinical studies. However, there are a large number of ongoing trials that may help to improve the evidence base.

The currently available evidence is from non-randomised, non-comparative observational studies, which limits any accurate assessment of Ekso's effectiveness. All 5 studies were single-centre trials done outside of the UK, which limits the generalisability of the results to NHS settings. Moreover, 2 were pilots for an earlier version of the device and a third was a pilot for a management protocol. The largest case series (Stampacchia 2016) only evaluated a single walking session, which lasted from 7 to 25 minutes.

The available studies report on short-term outcomes, and no longer-term outcomes have been reported. Study length ranged from 1 session per patient (approximately 40 minutes per session, including rest time) to up to 24 sessions at a rate of 1 or 2 sessions per week (up to 2 hours per session).

Table 1 summarises the clinical evidence as well as its strengths and limitations.

Table 1 Summary of selected evidence

Study

Intervention and comparator(s)

Outcomes

Strengths and limitations

Louie 2015

Systematic review.

15 studies (ranged from single-subject case studies to prospective trials comparing orthoses); 102 patients in total.

Number of centres not stated.

Countries not stated.

Intervention:

HAL (1 study)

Custom-powered IRGO (1 study)

ReWalk (5 studies)

Ekso (3 studies; earlier versions of the device)

Indego (3 studies)

Mina (1 study)

WPAL (1 study)

Comparator:

No studies had a control group; however in 2 studies the participants trialled both the device and a standard rigid orthoses.

Mean (SD) gait speed of non-ambulatory patients using Ekso at the end of training 0.14 (0.07) m/s.

The search included multiple databases and hand-searching, although it was limited to articles published in English.

There was heterogeneity in the study characteristics (device, control of stepping, training duration, outcome measurement), which reduces generalisability.

The outcome presented here (mean gait) was only reported in 1 (n=3) of the 3 included studies on Ekso.

Kolakowsky-Hayner 2013

Case series.

8 patients with complete SCI within 2 years of injury (only 7 completed therapy).

Single rehabilitation outpatients centre.

USA

Intervention:

Ekso: 6 weekly sessions with graduated time and less assistance in the Ekso device.

There were no major adverse events and minimal pain reports during and after use.

Loss of balance and falls were infrequent.

Over the training period, patients needed less help to transfer into and out of the device, and increased their time walking.

This was a small feasibility study using a prototype device and without a control. Clinicians did not have set algorithms for progression through training. Therefore, results are not generalisable.

The pilot focused on evaluating safety, and did not use advanced methods to monitor distance and speed, which were only shown graphically.

Kozlowski 2015

Case series.

7 patients with neurological weakness due to SCI.

Single rehabilitation outpatient centre.

USA

Intervention:

Ekso: up to 24 weekly sessions, each up to 2 hours long.

Heart rate changes and reported perceived exertion were consistent with light to moderate exercise.

All but one patient was able to stand, walk and sit with minimal assistance when using Ekso at end of training.

Secondary benefits were also reported for some patients with regard to sitting balance and bowel habit.

This was a small convenience sample of men only so results may not be generalisable to a wider population. There was no control group and the study had a high drop-out rate.

The study used a first-generation device, before a software upgrade.

Kressler 2014

Case series.

3 patients with complete SCI between T1 and T10 for ≥1 year.

Single academic research centre.

USA

Intervention:

Ekso: 3 days (1 hour per session) per week for 6 weeks.

Outcomes were measured in the first and last sessions when using Ekso and increases in steps taken, distance travelled and walking speed were recorded. The energy expenditure needed was similar to walking in people without disability but there were no changes in clinical measures of spasticity. All participants reported reduced pain severity.

Very small case series so extremely low patient numbers and no control. The study did not report which generation of the device was used, but the manufacturer has stated that this was the first-generation Ekso.

Sale 2016

Case series experimental A‑B design study.

3 patients with spinal cord injury.

Single rehabilitation outpatient centre.

Italy

Intervention:

Ekso: robot walking sessions for 45 minutes daily over 20 sessions.

All 3 patients showed substantial improvements in functional outcomes, including walking speed and step length. Improvements in spatiotemporal measures were also reported.

No adverse events, clinical instability or falls were reported.

Very small pilot study to evaluate a new rehabilitative protocol in patients who are not representative of the wider SCI population; no control group. The study did not report which generation of the device was used but the manufacturer has stated that this was the second-generation Ekso.

Stampacchia 2016

Case series.

Single rehabilitation outpatient centre.

Italy

Intervention:

Ekso: a single exercise session of about 40 minutes; total time of walking ranged from 7 to 25 minutes.

After the walking session, a significant decrease in muscle spasticity and pain intensity were observed.

Small study evaluating only a single short session with Ekso; no comparator.

Abbreviations: HAL, Hybrid Assistive Limb; HKAFO, hip-knee-ankle-foot orthosis; IRGO, isocentric reciprocal gait orthosis; PCI, physiological cost index; RCT, randomised controlled trial; RGO, reciprocating gait orthosis; SCI, spinal cord injury; SD, standard deviation; WPAL, Wearable Power Assist Locomotor.

Recent and ongoing studies