Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000634370
Ethics application status
Approved
Date submitted
1/10/2008
Date registered
15/12/2008
Date last updated
15/12/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Electrical stimulation to assist standing in paraplegia
Scientific title
Training of functional standing following spinal cord injury using two different electrical stimulation paradigms. A randomly ordered cross-over trial.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury 3779 0
Condition category
Condition code
Neurological 3952 3952 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Conventional low frequency (35Hz stimulation of quadriceps, hamstrings and gluteal muscles) functional electrical stimulation supported recumbent cycling. Participants are seated with their lower limbs strapped into pedals, electrical stimulation of lower limb muscles assists voluntary muscle work to cycle against a mechanical resistance set by the bicycle. Subjects will train for 40 minutes, resistance will be increased over the training period to ensure power output is optimised. Weight resistance (set to the individuals 8 repetition maximum) will be applied for inner range quadriceps muscle strength training. Range will be from approximately 20 degrees of knee flexion to full knee extension. Three repetitions of eight repeated contractions, with a two minute rest between each, will be used. Nine sessions of training over three weeks (3 per week) will be used in this arm of the study.
This is a cross-over study. First arm duration - 3 weeks; washout period - 2 weeks; second arm duration - 3 weeks.
Intervention code [1] 3492 0
Rehabilitation
Comparator / control treatment
Higher frequency (100Hz) electrical stimulation to support recumbent cycling training (40 minutes per session) and inner range quadriceps muscle strengthening (3 x 8RM as described above). Nine treatment sessions over three weeks (3 per week) will be applied in this arm of the study.
Control group
Active

Outcomes
Primary outcome [1] 4854 0
Duration of Functional Electrical Stimulation (FES) supported standing > 100% of baseline.
Timepoint [1] 4854 0
Time points: Measured pre-training, after first intervention phase (ie after three weeks of training) and after second intervention phase (ie after six weeks of training).
Primary outcome [2] 4855 0
Number of repeated sit-to-stand/stand-to-sit cycles before fatigue. Fatigue will be determined by the inability of the subject to perform the movement.
Timepoint [2] 4855 0
Time points: Measured pre-training, after first intervention phase (ie after three weeks of training) and after second intervention phase (ie after six weeks of training).
Primary outcome [3] 4856 0
Functional ability to reach forward and to the side while standing with FES support. The subject will be filmed from above while moving the hands over a flat board with a grid imprinted on it. Each hand in turn will be moved in an arc forward, then sideways. Then both hands will be moved together forwards. Amplitude of movement will be measured from digitisation of the video film.
Timepoint [3] 4856 0
Time points: Measured pre-training, after first intervention phase (ie after three weeks of training) and after second intervention phase (ie after six weeks of training).
Secondary outcome [1] 8199 0
Peak and mean isometric and isokinetic muscle moments (torque) generated by the quadriceps muscles with FES stimulation
Timepoint [1] 8199 0
Time points: Measured pre-training, after first intervention phase (ie after three weeks of training) and after second intervention phase (ie after six weeks of training).
Secondary outcome [2] 8200 0
Level of post-activation depression of H reflex will be measured using stimuli applied to the nerve every 4 seconds with increasing intensity until the maximal muscle action potential is reached. This will assess the size of the maximal M wave and the recruitment curve of the H reflex and the maximal H reflex. Quadriceps and soleus will be tested separately. Testing of post activation depression in quadriceps and soleus will set stimulus intensity sufficient to evoke an H reflex with an amplitude 50% maximum H reflex. Pairs of stimuli will be delivered with different interstimulus intervals: 1 s, 2.5 s, 5 s, and 10 s with 15 s between each pair of stimuli. Each interstimulus interval will be repeated 10 times. Quadriceps and soleus will be tested separately.
Timepoint [2] 8200 0
Time points: Measured pre-training, after first intervention phase (ie after three weeks of training) and after second intervention phase (ie after six weeks of training).

Eligibility
Key inclusion criteria
American Spinal Injuries Association (ASIA) C or D subjects (ie subjects will incomplete cord lesion involving some sparing of voluntary muscle activity below the level of the lesion) with spinal cord injury of >12 months standing
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Osteoporosis which would compromise the ability to stand or generate significant muscle moments about the knee or hip joints.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4028 0
Government body
Name [1] 4028 0
National Health and Medical Research Council [NHMRC] project 512351
Country [1] 4028 0
Australia
Primary sponsor type
Individual
Name
Jack Crosbie
Address
Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe
NSW 1825
Country
Australia
Secondary sponsor category [1] 3548 0
Individual
Name [1] 3548 0
Glen Davis
Address [1] 3548 0
Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe
NSW 1825
Country [1] 3548 0
Australia
Secondary sponsor category [2] 3549 0
Individual
Name [2] 3549 0
James Middleton
Address [2] 3549 0
Moorong Spinal Unit
Royal Rehabilitation Centre
PO Box 6
Ryde
NSW 1680
Country [2] 3549 0
Australia
Secondary sponsor category [3] 3550 0
Individual
Name [3] 3550 0
Jane Butler
Address [3] 3550 0
Prince of Wales Medical Research Institute
Barker Street
Randwick
NSW 2031
Country [3] 3550 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6026 0
The University of Sydney Human Ethics Committee
Ethics committee address [1] 6026 0
University of Sydney
Room 313, Old Teachers College
NSW 2006
Ethics committee country [1] 6026 0
Australia
Date submitted for ethics approval [1] 6026 0
Approval date [1] 6026 0
30/04/2008
Ethics approval number [1] 6026 0
04-2008/10769
Ethics committee name [2] 6027 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [2] 6027 0
Rupert Myers Building
Barker Street,
Kensington
NSW 2052
Ethics committee country [2] 6027 0
Australia
Date submitted for ethics approval [2] 6027 0
Approval date [2] 6027 0
29/05/2008
Ethics approval number [2] 6027 0
HREC 08153

Summary
Brief summary
The purpose of this research is to investigate the use of electrical stimulation to support a muscle strengthening program aimed at increasing standing function in individuals with incomplete spinal cord injury (SCI). Specifically, this project will establish whether there are any differences in outcome using a conventional stimulation pattern (low frequency) or a new, higher frequency stimulation pattern.
The project will test the hypotheses that, following training using a combined FES-voluntary muscle strengthening program, motor-incomplete SCI individuals will be able:
1. to stand for longer;
2. to perform significantly more repetitions of the sit-to-stand/stand-to-sit activity ;
3. to achieve significantly greater upper limb reach.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28994 0
Address 28994 0
Country 28994 0
Phone 28994 0
Fax 28994 0
Email 28994 0
Contact person for public queries
Name 12151 0
Jack Crosbie
Address 12151 0
Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe
NSW 1825
Country 12151 0
Australia
Phone 12151 0
+612 9351 9180
Fax 12151 0
Email 12151 0
j.crosbie@usyd.edu.au
Contact person for scientific queries
Name 3079 0
Jack Crosbie
Address 3079 0
Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe
NSW 1825
Country 3079 0
Australia
Phone 3079 0
+612 9351 9180
Fax 3079 0
Email 3079 0
j.crosbie@usyd.edu.au

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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