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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00108043