The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000583842
Ethics application status
Approved
Date submitted
28/05/2012
Date registered
30/05/2012
Date last updated
21/11/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Gait support for acute and sub-acute patients who demonstrate foot drop following stroke
Scientific title
In people following acute and subacute stroke does gait support using the Bioness L300 improve gait compared to usual rehabilitation?
Secondary ID [1] 273439 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 279226 0
Condition category
Condition code
Stroke 279433 279433 0 0
Ischaemic
Stroke 286859 286859 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 286860 286860 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 283770 0
Treatment: Devices
Intervention code [2] 284949 0
Rehabilitation
Comparator / control treatment
Comparator group will receive standard treatment prescribed by rehabilitation team.
Control group
Active

Outcomes
Primary outcome [1] 286001 0
Walking ability measured as walking speed during 10 m walk test.
Timepoint [1] 286001 0
Discharge from hospital or when L300 no longer clinically required; at 4, 8 and 12 weeks post discharge from hospital
Secondary outcome [1] 294942 0
Feasibility measured as number of stroke survivors who successfully use the L300; duration, sessions, steps taken using the L300; patient and therapist perception of usefulness determined through 10-point rating scale; adverse events including falls and skin irritation.
Timepoint [1] 294942 0
At discharge from hospital or when L300 no longer required.
Secondary outcome [2] 294943 0
Achievement of motor milestones: time to independent sitting balance, standing balance, 10 steps, 10 m walk test.
Timepoint [2] 294943 0
During hospital admission, dates will be recorded when these motor milestones are achieved.
Secondary outcome [3] 294944 0
Balance measured using Balance Outcome Measure for Elder Rehabilitation
Timepoint [3] 294944 0
At discharge from hospital or when L300 no longer required.
Secondary outcome [4] 294945 0
Walking capacity measured using six minute walk test
Timepoint [4] 294945 0
At discharge from hospital or when L300 no longer required.
Secondary outcome [5] 294946 0
Modified Barthel Index
Timepoint [5] 294946 0
4, 8 and 12 weeks post discharge from hospital
Secondary outcome [6] 294947 0
Quality of life using Euroqol 5D
Timepoint [6] 294947 0
4, 8 and 12 weeks post discharge from hospital

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be enrolled in the study by treating physiotherapists. Sites have been allocated to being an intervention or control site. participants, therapists and study investigators will not be blind to intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284248 0
Government body
Name [1] 284248 0
Queensland Health
Address [1] 284248 0
Charlotte Street
Brisbane QLD 4001
Country [1] 284248 0
Australia
Primary sponsor type
Government body
Name
Queensland Rural Stroke Outreach Service
Address
Geriatric and Rehabilitation Unit,
Cartright Street Windsor Qld 4029
Country
Australia
Secondary sponsor category [1] 269203 0
Other Collaborative groups
Name [1] 269203 0
Queensland Rehabilitation Physiotherapy Network
Address [1] 269203 0
The Prince Charles Hospital
Rode Road
Chermside QLD 4032
Country [1] 269203 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286214 0
Metro North - The Prince Charles Hospital HREC
Ethics committee address [1] 286214 0
Administration Building
Lower Ground
The Prince Charles Hospital
Rode Road, Chermside QLD 4032
Ethics committee country [1] 286214 0
Australia
Date submitted for ethics approval [1] 286214 0
Approval date [1] 286214 0
31/08/2011
Ethics approval number [1] 286214 0
HREC/11/QPCH/136

Summary
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.
Trial website
Trial related presentations / publications
Kuys SS, Clarke J, Lynch M, Dilworth C. Portable peroneal electrical stimulation early following stroke: risks and recovery. Smarts Stroke Conference 9th Australasian Nursing & Allied Health Stroke Conference. International Journal of Stroke 2013, 8; Supp 2, 11.

Kuys SS, Clarke J, Dilworth C, Lynch M. Peroneal electrical stimulation: application early following stroke. 24th Annual Scientific Meeting of the Stroke Society of Australia. International Journal of Stroke 2013, 8; Supp 1, 29.

Kuys S, Clarke J, Lynch M, Stewart C, Dilworth C, Grimley R. Portable electrical stimulation early following stroke: a protocol. Stroke Society of Australasia, 2012. International Journal of Stroke; 2012, 7 S1:32.
Public notes

Contacts
Principal investigator
Name 33426 0
Dr Suzanne Kuys
Address 33426 0
The Prince Charles Hospital, Rode Road, Chermside, Queensland 4032
Country 33426 0
Australia
Phone 33426 0
61 7 31396319
Fax 33426 0
Email 33426 0
suzanne.kuys@health.qld.gov.au
Contact person for public queries
Name 16673 0
Dr Dr Suzanne Kuys
Address 16673 0
Allied Health Research Collaborative
The Prince Charles Hospital
Rode Road, Chermside QLD 4032
Country 16673 0
Australia
Phone 16673 0
61 7 3139 6319
Fax 16673 0
Email 16673 0
suzanne_kuys@health.qld.gov.au
Contact person for scientific queries
Name 7601 0
Dr Dr Suzanne Kuys
Address 7601 0
Allied Health Research Collaborative
The Prince Charles Hospital
Rode Road, Chermside QLD 4032
Country 7601 0
Australia
Phone 7601 0
61 7 3139 6319
Fax 7601 0
Email 7601 0
suzanne_kuys@health.qld.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary