Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000079246
Ethics application status
Approved
Date submitted
4/12/2008
Date registered
2/02/2009
Date last updated
23/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Electrical stimulation and strength training to improve quadriceps strength in people with incomplete spinal cord injuries
Scientific title
Electrical stimulation and strength training to improve quadriceps strength in people with incomplete spinal cord injuries
Secondary ID [1] 283464 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
spinal cord injury 4063 0
Condition category
Condition code
Neurological 4482 4482 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The experimental intervention will be based on the principles of progressive-resistance training. The intervention will be delivered to one leg, 3 times a week, over an 8-week period. Participants will perform two sets of 6 X 10 leg extension exercises against a weighted resistance. The first set of 6 X 10 leg extension exercises will require participants to voluntarily and maximally contract their quadriceps muscles with ES superimposed. The second set of 6 X 10 leg extension exercises will not require participants to voluntarily contract their quadriceps muscles. Instead this set will be done with ES alone. During both sets participants will extend the knee against resistance equivalent to 10 repetitions maximum (10 RM). There will be a 3 minute rest after each 10 lifts.

The resistance will be applied through a device specifically designed for the purpose. Briefly, the device will consist of a wheel attached to a leg bar. A weight will be hung from a rope which wraps around the wheel and attaches to the leg bar. The participant will be required to extend the knee against the leg bar. This will necessitate lifting the weight suspended from the wheel. Training of experimental lower limb increased according to the principles of progressive resistance training. That is, if participants could lift the weight more than 10 times per set, the weight was too light and increased. In the experimental lower limb this progression also involved increasing stimulation intensity as tolerated up to 100 mA
Intervention code [1] 3785 0
Rehabilitation
Comparator / control treatment
The control group will recieve no intervention or placebo intervention. All participants will be living in the community and most will not be receiving any other related health care.
Control group
Active

Outcomes
Primary outcome [1] 5156 0
Knee extension strength: A Biodex dynamometer will be used to measure peak isokinetic knee extension torque. Initially the torque generated by the weight of the leg will be measured by passively moving the knee through range. Participants will then be required to perform six maximal effort knee extension contractions at 30 degrees.sec-1, between a 100 degree and 165 degree range of the biodex. There will be a 60 second rest between each trial.
Timepoint [1] 5156 0
Baseline (prior to allocation) and 8 weeks later.
Primary outcome [2] 5157 0
Knee extension fatigue ratio: A Biodex dynamometer will be used to measure knee extension fatigue ratio at 20 degrees.sec-1, between a 100 degrees and 165 degree range. Participants will be required to perform repeated maximal knee extension contractions over a 3-minute period. Each dynamic contraction will last for 3 seconds followed by a 3 second rest. If the joint range of motion is limited, the speed will be reduced accordingly. The fatigue ratio will be represented by average strength over the first five contractions divided by average strength over the last five contractions.
Timepoint [2] 5157 0
Baseline (prior to allocation) and 8 weeks later.
Primary outcome [3] 5158 0
Canadian Occupational Performance Measure. Participants will be asked to identify and rate three goals of therapy related to leg function. The rating will a 10-point scale based on task importance, task performance and outcome satisfaction.
Timepoint [3] 5158 0
Baseline (prior to allocation) and 8 weeks later.
Secondary outcome [1] 8675 0
Stimulated knee extension strength: A Biodex dynamometer will be used to measure stimulated peak isokinetic knee extension torque. A Biodex dynamometer will be used to measure stimulated knee extension strength at 30 degrees.sec-1. The quadriceps muscles will be maximally stimulated whilst the participant's leg is passively moved through range. There will be a 60 second rest between each trial. Stimulation will be delivered at either 100mA or the maximum intensity tolerated by the participant. The best effort will be selected and recorded.
Timepoint [1] 8675 0
Baseline (prior to allocation) and 8 weeks later.
Secondary outcome [2] 8676 0
Stimulated knee extension fatigue ratio: A Biodex dynamometer will be used to measure stimulated knee extension fatigue ratio at 20 degrees.sec-1. Participants will be required to perform repeated passive maximal dynamic knee extension contractions over a 3-minute period with electrical stimulation. Each contraction will last 3 seconds followed by a second rest. The quadriceps muscles will be maximally stimulated at the same time. Stimulation will be delivered at either 100mA or the maximum intensity tolerated by the participant. The fatigue ratio will be represented by average strength over the first five contractions divided by average strength over the last five contractions.
Timepoint [2] 8676 0
Baseline (prior to allocation) and 8 weeks later.
Secondary outcome [3] 8677 0
Clinical impression of change: At the completion of the trial participants will be asked to rate their impressions of change in strength on a 15-point scale where -7 indicates ?a very great deal worse?, 0 indicates ?no change? and +7 indicates ?a very great deal better?.
Timepoint [3] 8677 0
8 weeks after baseline.

Eligibility
Key inclusion criteria
1. a neurologically stable spinal cord injury at the level of C4 or below
2. partial paralysis of the quadriceps muscles (ie. complete ASIA A spinal cord injury with zones of partial preservation or an incomplete ASIA B, C or D spinal cord injury)
3. at least grade 3 strength in the quadriceps muscles on one leg
4. sustained a SCI more than six months prior to testing
5. quadriceps muscles can be electrically stimulated
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. living outside Sydney
2. other types of neurological lesions affecting the lower limbs

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)
A participant will be entered into the trial when baseline details are logged at the central site and the allocation is provided. Concealled allocation will be achieved through the use of sealed opaque envelopes. The envelopes will be kept off-site by an independent person and not opened until after each participant's baseline measurements.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation schedules will generated by computer prior to commencement of the study by an independent person and kept at a central off-site location.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Blocked randomisation will be used.
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/11/2008
Actual
11/11/2008
Date of last participant enrolment
Anticipated
Actual
16/07/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 4245 0
Government body
Name [1] 4245 0
NSW Ministry of Science and Medical Research
Country [1] 4245 0
Australia
Primary sponsor type
University
Name
Rehabilitation Studies Unit, Faculty of Medicine, University of Sydney
Address
PO Box 6, Ryde 1680
Country
Australia
Secondary sponsor category [1] 3817 0
Hospital
Name [1] 3817 0
Royal Rehabilitation Centre Sydney
Address [1] 3817 0
PO Box 6, Ryde 1680
Country [1] 3817 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6297 0
University of Sydney
Ethics committee address [1] 6297 0
Room 313, Level 3, Old Teachers College A22
Ethics committee country [1] 6297 0
Australia
Date submitted for ethics approval [1] 6297 0
Approval date [1] 6297 0
11/09/2008
Ethics approval number [1] 6297 0
09-2008/11102
Ethics committee name [2] 295090 0
North Sydney Central Coast Area Health Service HREC
Ethics committee address [2] 295090 0
Royal North Shore Hospital
St Leonards, NSW, 2065
Ethics committee country [2] 295090 0
Australia
Date submitted for ethics approval [2] 295090 0
02/06/2008
Approval date [2] 295090 0
31/10/2008
Ethics approval number [2] 295090 0

Summary
Brief summary
The purpose of this study is to determine the effectiveness of delivering electrical stimulation in conjunction with traditional strength training in the quadriceps muscles of people with incomplete spinal cord injuries. The study will be undertaken over an eight-week period. This research can help physiotherapists understand how best to strengthen weak muscles in persons with incomplete spinal cord injuries. The quadriceps muscles are being used as a model to determine the effectiveness of regular electrical stimulation and strength training to all large muscle groups.
Trial website
Trial related presentations / publications
Harvey L, Fornusek C, Bowden JL, Pontifex N, Glinsky J, Middleton J, Gandevia S, Davis GM (2010) Electrical stimulation plus progressive resistance training for leg strength in spinal cord injury: A randomized-controlled trial. Spinal Cord. 48: 570-575.

Harvey L, Fornusek C, Bowden J, Pontifex N, Glinsky J, Middleton J, Gandevia S, Davis G (2010) Electrical stimulation combined with progressive resistance training increases strength in people with spinal cord injury. The International Spinal Cord Society (ISCOS), India.

Harvey LA, Fornusek C, Bowden JL, Pontifex N, Glinsky J, Middleton M, Gandevia SC, Davis GM (2011) Electrical stimulation combined with progressive resistance training increases strength in people with spinal cord injury. World Confederation of Physical Therapy. Amsterdam, Netherlands.
Public notes

Contacts
Principal investigator
Name 29195 0
Prof Lisa Harvey
Address 29195 0
John Walsh Centre for Rehabilitation Research
The University of Sydney
Level 13, Kolling Institute,
Royal North Shore Hospital, St Leonards, NSW, 2065
Country 29195 0
Australia
Phone 29195 0
+61 2 99264594
Fax 29195 0
Email 29195 0
l.harvey@usyd.edu.au
Contact person for public queries
Name 12352 0
Prof Lisa Harvey
Address 12352 0
John Walsh Centre for Rehabilitation Research
The University of Sydney
Level 13, Kolling Institute,
Royal North Shore Hospital, St Leonards, NSW, 2065
Country 12352 0
Australia
Phone 12352 0
+61 2 99264594
Fax 12352 0
2 9926 4045
Email 12352 0
l.harvey@usyd.edu.au
Contact person for scientific queries
Name 3280 0
Prof Lisa Harvey
Address 3280 0
John Walsh Centre for Rehabilitation Research
The University of Sydney
Level 13, Kolling Institute,
Royal North Shore Hospital, St Leonards, NSW, 2065
Country 3280 0
Australia
Phone 3280 0
+61 2 99264594
Fax 3280 0
+61 2 99264045
Email 3280 0
l.harvey@usyd.edu.au

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffects of electrical stimulation of vastus medialis obliquus muscle in patients with patellofemoral pain syndrome: An electromyographic analysis. [Portuguese]2010
N.B. These documents automatically identified may not have been verified by the study sponsor.