Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001598875
Ethics application status
Approved
Date submitted
25/10/2021
Date registered
22/11/2021
Date last updated
14/01/2024
Date data sharing statement initially provided
22/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Electrical stimulation-eccentric muscle strength training in people with spinal cord injury
Scientific title
Effects of electrically-evoked eccentric strength training on muscle mass, strength, spasticity and quality of life in people with spinal cord injury.
Secondary ID [1] 305285 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This is a follow-up study from ACTRN12618000018213, however it is been conducted in a different organisation, as the main researcher has done this previous study as part of her PhD studies at Edith Cowan University, and it is currently working at Central Queensland University, QLD, Australia.

Health condition
Health condition(s) or problem(s) studied:
spinal cord injury 323586 0
Condition category
Condition code
Physical Medicine / Rehabilitation 321132 321132 0 0
Physiotherapy
Neurological 321802 321802 0 0
Other neurological disorders
Injuries and Accidents 321803 321803 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Neuromuscular electrical stimulation combined with eccentric muscle strength training in people with SCI:
We will conduct a non-randomised 6-week pilot clinical trial study intervention in four persons with spinal cord injury (SCI), lesion below the level of C6 (age range = 18-65 years, ASIA A-D). Participants will be recruited from the local community (Rockhampton).

Description of the intervention

Protocol: NMES eccentric training will commence after the warm-up and testing that will be described under "Control Test". Intensity of the intervention will be informed by the baseline twitch torque knee extension test. 3 sets of 5 repetitions will be completed at half the current intensity used to evoke the maximum isometric tetanic torque as part of the ‘warm-up’. The stimulation amplitude will be controlled manually to make sure the force profile in each repetition does not drop significantly due to fatigue. The dynamometer will flex the knee at 30°·s-1 to provide a concentric action from 90°of flexion to full knee-extension and an eccentric action from full knee extension to 90°of flexion. The bouts of electrical stimulation will only be delivered during the eccentric phase (i.e. from full knee extension to 90 degrees of knee flexion). In-built safety limits will be set so torques 10% greater than the target torque, which may be produced through spasms, will trigger the system to immediately stop the stimulation delivery in order to minimise injury risk. Three attempts will be given for individuals to complete the training without triggering the safety mechanism before the session will be ended. During the consequent intervention session, the current intensity used will evoked 80% of the maximum tetanic torque. Thereafter, current intensities of 100% will be used, with 5 sets of 10 repetitions being completed during all training sessions. The intensity of exercise will increase as the muscle strength increases. Participants who are unable to complete a session due to spasms will repeat exercise at the next session; progression to full training will only occur once the training can be done without detectable spasm.

All intervention sessions will be conducted by two people, one is a Senior Physiotherapist with research experience and a the second one is a trained research assistant. The participants will be asked to keep their physical training routine consistent for the duration of the experiment.
The duration of each session will be 1 hour approximately. Session attendance checklist will be used to monitor adherence to the intervention.
The procedures that will be used in this study will be similar from a methodology used in a previous study in people with spinal cord injury (SCI): Trial ID: ACTRN12618000018213.
Intervention code [1] 321690 0
Treatment: Devices
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328914 0
Knee-extension torque measurements using an isokinetic dynamometer (Biodex System 3 Pro Ronkonkoma, NY). Evoked tetanic knee-extension torque is the primary outcome, as this is the amount of force developed by the muscle as a result of the electrical stimulation.
Timepoint [1] 328914 0
Testing will be completed on four occasions: 1) baseline (T0); 2) after a 2 -week control period (T1); 3) within 3-5 days after the completion of the 6-week intervention (T2); and 4) between 4-6 weeks after the intervention (T3).
Primary outcome [2] 328915 0
Muscle cross-sectional area of quadriceps femoris (CSA-QF) using B-mode axial-plane ultrasonography.
Timepoint [2] 328915 0
1) baseline (T0); 2) after a 2 -week control period (T1); 3) within 3-5 days after the completion of the 6-week intervention (T2); and 4) between 4-6 weeks after the intervention (T3).
Primary outcome [3] 328916 0
Spasticity measure using the Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET)
Timepoint [3] 328916 0
1) baseline (T0); 2) after a 2 -week control period (T1); 3) within 3-5 days after the completion of the 6-week intervention (T2); and 4) between 4-6 weeks after the intervention (T3).
Secondary outcome [1] 400857 0
Quality of life measure (QoL) using the Quality of life Index (QLI) for people with spinal cord injuries (SCI).
Timepoint [1] 400857 0
1) baseline (T0); 2) after a 2 -week control period (T1); 3) within 3-5 days after the completion of the 6-week intervention (T2); and 4) between 4-6 weeks after the intervention (T3).
Secondary outcome [2] 403008 0
Peak twitch torque will be measured using an isokinetic dynamometer (Biodex System 3 Pro Ronkonkoma, NY). This is the amount of evoked muscle force elicited by a specific current of electrical stimulation, called twitch.
Timepoint [2] 403008 0
1) baseline (T0); 2) after a 2 -week control period (T1); 3) within 3-5 days after the completion of the 6-week intervention (T2); and 4) between 4-6 weeks after the intervention (T3).

Eligibility
Key inclusion criteria
Inclusion criteria: age 18-65 years; SCI longer than 6 months that led to complete or incomplete paraplegia or tetraplegia; level of injury between C2 and L5; AIS (American Spinal Cord Injury Association Impairment Scale) A, B, C or D; have medical permission to enrol in an intensive exercise program; and able to attend consistently two times per week for 6 weeks in addition to committing to baseline and follow up testings at CQUniversity North Rockhampton, QLD, Australia laboratory located on Building 81.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Acute phase of injury (less than 6 months from injury); ventilator dependent, other associated neurological disease; and complications such as severe urinary infection, pressure ulcers, previous lower-limb fractures or any other health condition that may constrain the participation in an exercise program.

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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Repeated ANOVA tests will be used to compare T0,T1,T2 and T3 in peak twitch torque, evoked tetanic torque, cross-sectional area (CSA), symptoms of spasticity, and QoL outcomes. Reliability of the outcome measures between the baseline and control tests will be assessed using the intra-class correlation coefficient (ICC). Statistical significance will be set at an alpha level of equal to or less than 0.05 and values will be reported as mean and SD.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2022
Actual
2/05/2022
Date of last participant enrolment
Anticipated
1/02/2023
Actual
2/05/2022
Date of last data collection
Anticipated
31/03/2023
Actual
31/03/2023
Sample size
Target
4
Accrual to date
Final
2
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 309657 0
University
Name [1] 309657 0
Central Queensland University
Country [1] 309657 0
Australia
Primary sponsor type
Individual
Name
Vanesa Bochkezanian
Address
Central Queensland University. Building 34 Office 1.02, Bruce Highway, Rockhampton North, QLD, Australia 4702
Country
Australia
Secondary sponsor category [1] 311233 0
None
Name [1] 311233 0
n/a
Address [1] 311233 0
n/a
Country [1] 311233 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309424 0
Central Queensland University Human Research Ethics Committee
Ethics committee address [1] 309424 0
Ethics committee country [1] 309424 0
Australia
Date submitted for ethics approval [1] 309424 0
03/11/2021
Approval date [1] 309424 0
22/02/2022
Ethics approval number [1] 309424 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114114 0
Dr Vanesa Bochkezanian
Address 114114 0
Central Queensland University. Bruce Highway, North Rockhampton campus, QLD, Australia (4702)
Country 114114 0
Australia
Phone 114114 0
+61 0421166741
Fax 114114 0
Email 114114 0
[email protected]
Contact person for public queries
Name 114115 0
Vanesa Bochkezanian
Address 114115 0
Central Queensland University. Bruce Highway, North Rockhampton campus, QLD, Australia (4702)
Country 114115 0
Australia
Phone 114115 0
+61 0421166741
Fax 114115 0
Email 114115 0
[email protected]
Contact person for scientific queries
Name 114116 0
Vanesa Bochkezanian
Address 114116 0
Central Queensland University. Bruce Highway, North Rockhampton campus, QLD, Australia (4702)
Country 114116 0
Australia
Phone 114116 0
+61 0421166741
Fax 114116 0
Email 114116 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To protect privacy of participants as this is a pilot study


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
No additional documents have been identified.