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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00108043




Registration number
NCT00108043
Ethics application status
Date submitted
12/04/2005
Date registered
13/04/2005
Date last updated
3/12/2015

Titles & IDs
Public title
Orthostatic Tolerance During FES (Functional Electrical Stimulation)-Walking in Paraplegia
Scientific title
Orthostatic Tolerance During FES-evoked Stepping in Paraplegia: A Safety and Viability Study
Secondary ID [1] 0 0
NHMRC 302013
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - FES-evoked functional upright gait

Treatment: Surgery: FES-evoked functional upright gait
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change of systolic blood pressure during three FES-evoked stepping conditions
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Cardiovascular and Metabolic Responses
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Autonomic Responses
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Muscle Metabolic Responses
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Humoral Responses
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Syncope Symptom Score
Timepoint [5] 0 0

Eligibility
Key inclusion criteria
- Male

- A spinal cord lesion, of traumatic etiology, between the 6th and 11th thoracic spinal
segments

- Sensory and motor complete lesion (ASIA [American Spinal Injury Association]-A)

- At least 2 years post injury

- Between 18-55 years of age

- Responsive to electrical stimulation
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Severe osteoporosis, fractures, dislocations (as determined by X-ray and DEXA)

- Upper limb or shoulder pathologies

- Severe spasticity (=4 on Ashworth scale)

- Contractures

- Currently undertaking FES or gait training

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2006
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Rehabilitation Research Centre, University of Sydney - Sydney
Recruitment postcode(s) [1] 0 0
2141 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Objective:

The objective of this research is to undertake a safety and viability study of FES-evoked
stepping in individuals with paraplegia. The rationale for this objective is based upon the
need to clarify whether physiological limitations, especially orthostatic intolerance, limit
functional mobility outcomes. The cardiovascular, autonomic, and muscle metabolic factors
governing orthostatic tolerance during skin-surface FES stepping will be investigated, since
this functional task forms the basis of upright mobility and engenders strong physiological
challenges upon key regulatory processes in the SCI (spinal cord injury) patient.

Specific Hypotheses:

i. Reduction of blood pressure will be greater during FES-evoked stepping than during passive
stepping; ii. Reduction of blood pressure will be greater during FES-evoked stepping with no
upper body component versus FES-stepping with an upper body component; iii. Blood pressure
will be reduced even further during FES-evoked stepping following a 6-week
progressive-intensity gait training intervention.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00108043
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Glen M Davis, PhD, FACSM
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00108043