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Gait support for acute and sub-acute patients who demonstrate foot drop following stroke

In people following acute and subacute stroke does gait support using the Bioness L300 improve gait compared to usual rehabilitation?

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000583842
Enrollment
150
Registered
2012-05-30
Start date
2012-02-28
Completion date
2012-11-30
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The QH Rural Stroke Outreach Service and the Queensland Rehabilitation Physiotherapy Network are investigating the use of the Bioness NESS L300 (L300) to support gait recovery in people following stroke with foot drop. A prospective clinical controlled study involving eight rehabilitation units is planned. Each participating site has nominated to be either an intervention or a control site. Following familiarisation, participants will use the L300 during physiotherapy treatment once medically stable until they are discharged or the L300 is no longer clinically required. Participants will be followed up by phone at 4, 8 and 12 weeks following recruitment to the study.

Interventions

Bioness Ness L300 Foot Drop System will be used in people admitted to hospital following stroke. Dose, intensity and activities of use will not be specified but will be described. The L300 is a wireless peroneal nerve electrical stimulation unit, which promotes ankle dorsiflexion after toe off and during the swing phase of gait (TGA Approval number 152654). The unit will be fitted by a trained physiotherapist and participants will wear the device during physiotherapy intervention and managemen

Bioness Ness L300 Foot Drop System will be used in people admitted to hospital following stroke. Dose, intensity and activities of use will not be specified but will be described. The L300 is a wireless peroneal nerve electrical stimulation unit, which promotes ankle dorsiflexion after toe off and during the swing phase of gait (TGA Approval number 152654). The unit will be fitted by a trained physiotherapist and participants will wear the device during physiotherapy intervention and management. Devices will be worn by participants as required and will be at the discretion of the physiotherapist.

Sponsors

Queensland Rural Stroke Outreach Service
Lead SponsorGovernment body

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Diagnosed as stroke Receiving physiotherapy rehabilitation Are medically stable Able to understand simple instructions If walking, foot drop is evident during walking without adaptive AFO Muscle weakness of the paretic ankle dorsiflexors and/or evertors Have a minimum 4 sessions with NESS L300

Exclusion criteria

Other neurological or musculoskeletal condition affecting lower limbs that would limit walking ability e.g. Parkinson’s Disease, severe osteoarthritis, spinal cord injury, cerebral palsy, multiple sclerosis

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026