ReStore Soft Exo-Suit for gait rehabilitation

Study size, design and location

A multisite, non-comparative evaluation using the ReStore Soft Exo-Suit in post-stroke rehabilitation sessions for 44 people recovering from stroke. Thirty-six of the 44 people completed the evaluation and were included in the analysis. All of the study sites were in the US.

Intervention and comparator(s)

Over a maximum of 4 weeks, people had a walking evaluation then 5 physiotherapy sessions, at a rate of at least 2 per week, and then a second walking evaluation. Each physiotherapy session consisted of up to 20 minutes of walking on the ground and 20 minutes walking on a treadmill, both while using ReStore. There was no comparator.

Key outcomes

The primary outcome of the study was the frequency of device-related adverse events and falls. Device-related adverse events occurred in less than 10% of study visits and were mostly mild in severity, such as pain in the lower extremity and skin abrasions. Part way through the study the manufacturer implemented mandatory training on fitting ReStore and the rate of adverse events then fell. No device-related falls or serious adverse events were reported.

Secondary outcomes were clinician safety (device-related injuries to the physiotherapists) and device reliability. No clinician injuries were reported. Device malfunctions were reported in 11.6% of physiotherapy sessions in the study.

An exploratory assessment of changes in maximum walking speed was included in the study. Overall, there was an average increase in ReStore-assisted walking speed of 0.1 m/s. Approximately 61% of 36 people had a 'small meaningful change' in their ReStore-assisted walking speed (0.05 m/s or more faster than baseline) and 44% had a 'large meaningful change' (0.1 m/s or more faster than baseline). The average increase in non-assisted walking speed was 0.07 m/s.

Strengths and limitations

This study was designed to show the ReStore's safety. The reported patient outcomes were described as a secondary, exploratory assessment only. The study is non-comparative. Long-term outcomes were not investigated.

Study size, design and location

An evaluation of the feasibility of using ReStore Soft Exo-Suit to restore normal gait mechanics and energetics after stroke. The study included 9 adults in the chronic stage of stroke recovery and was in the US.

Intervention and comparator(s)

Two versions of ReStore were used in this study: one used an 'off-board' actuation unit, meaning that it was on a trolley and connected by cables rather than being built into the suit; the other was the commercial version with the actuator worn on the waistbelt. People in the trial completed 2 treadmill walking trials using ReStore. There was no comparator.

Key outcomes

The study aimed to demonstrate the feasibility of using the ReStore in gait training, and to evaluate immediate outcomes in terms of gait symmetry and metabolic burden, which can contribute to inactivity in older adults.

Interlimb peak propulsion asymmetry during treadmill walking using the off-board actuator suit with mechanical assistance was 20% lower (range 4%) than using the suit without mechanical assistance. The energy cost of walking was 10% lower (range 3%) than with no mechanical assistance.

Propulsion asymmetry in overground walking using the commercial version of ReStore with mechanical assistance was 16.3% lower (range 6.8%) than wearing the suit without mechanical assistance. The energy cost of walking was not reported.

Strengths and limitations

Long-term outcomes for gait or mobility were not reported. It was a small, non-comparative study. Results from trials using the off-board actuator exosuit (weighing around 1 kg) may not reflect the commercial, actuator-bearing version of ReStore (weighing around 5 kg).

Study size, design and location

A single session study comparing walking with and without the ReStore Soft Exo-Suit. It included 8 adults in the chronic phase of stroke recovery and was in the US.

Intervention and comparator(s)

Eight adults who were recovering from a stroke (which had happened at least 6 months before the study) completed 2 treadmill walking trials lasting 8 minutes each. In 1 trial the suit was worn unpowered, with no mechanical assistance. In the other trial the suit was powered with mechanical assistance to support walking. In both trials the off-board actuator version of ReStore was worn rather than the commercial version with the actuator on the waist. There was no comparator.

Key outcomes

Post-stroke gait-compensation was assessed by measuring circumduction (a walking style in which the leg is unbent as it swings forward so it rotates forward in a circular movement) and hip hiking (the angle of the pelvis when the affected leg is in mid-swing).

Hip hiking with mechanical assistance was lower by an average of 27% (standard error 6%) on the affected leg than without mechanical assistance. Circumduction was lower by an average of 20% (standard error 5%) on the affected leg. No change in either measure was recorded in the unaffected leg.

Strengths and limitations

Long-term outcomes for gait or mobility were not reported. It was unclear whether there is overlap in the patient cohorts between the 2 studies by Awad et al. in 2017. Results from trials using the off-board actuator exosuit (weighing around 1 kg) may not reflect the commercial, actuator-bearing version of ReStore (weighing around 5 kg).