Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000223730
Ethics application status
Approved
Date submitted
24/01/2022
Date registered
8/02/2022
Date last updated
21/01/2024
Date data sharing statement initially provided
8/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Mollii Suit 60-minute trial in people with a Spinal Cord Injury
Scientific title
The short-term effect of wearing an electrodress suit on physical function after spinal cord injury: a randomised placebo-controlled cross-over trial
Secondary ID [1] 306262 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal cord injury 325009 0
spasticity 325011 0
Condition category
Condition code
Neurological 322445 322445 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 322446 322446 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 322520 322520 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Mollii Electrodress (TGA approved) suit consists of separate, long-sleeved upper and lower body garments with implanted electrodes that deliver customised low-level electrical stimulation. People wear both garments of the suit for one hour at a time while performing activities of daily living on two separate occasions, one week apart. The electrodes of the suit are set by a trained Mollii Suit Therapist at 20volts, with a pulse width between 25-175us, at 20Hz. On the one occasion (randomised) the participant will wear the suit for one hour, but the customised configuration will not deliver the electrical stimulation. The parameters are designed so that regardless of if the stimulation Mollii suit is turn on or not, there is not visible muscle contraction nor is there noticeable sensation of electrical stimulation. The effectiveness of the intervention will be assessed before and after wearing the suit for one hour, and 2 days after removal. The duration of suit application, activities performed and electrical stimulation parameters of the suit for each person will be recorded for the two occasions it is worn.
Intervention code [1] 322679 0
Treatment: Devices
Comparator / control treatment
The control treatment involves wearing the Mollii suit (both upper and lower garments) without the low-level stimulation for one hour while performing activities of daily living.
Control group
Placebo

Outcomes
Primary outcome [1] 330224 0
Time to complete the Timed Up and Go test will assess participants functional strength, balance and mobility. A chair of standard height and a digital stop watch will be used in this assessment.
Timepoint [1] 330224 0
2 weeks post-intervention commencement
Secondary outcome [1] 405351 0
Self-reported spasticity of the lower limbs (while performing Timed Up and Go test) using a 10cm visual analogue scale expressed as a line for the participant to make a mark on from 0 = no spasticity to 10 = worst spasticity experienced
Timepoint [1] 405351 0
2 weeks post-intervention commencement
Secondary outcome [2] 405352 0
Self-reported pain in the whole body (while performing Timed Up and Go test) using a 10cm visual analogue scale expressed as a line for the participant to make a mark on from 0 = no pain to 10 = worst pain experienced
Timepoint [2] 405352 0
2 weeks post-intervention commencement
Secondary outcome [3] 405353 0
Clinical assessed spasticity of the knee flexors using the Modified Ashworth Scale. This scale is a standardised assessment where a therapist rates the knee flexor muscles on scale from 0-4, where 0=no spasticity and 4 = unable to move joint.
Timepoint [3] 405353 0
2 weeks post-intervention commencement
Secondary outcome [4] 405354 0
Passive range of motion of knee extension using a standard goniometer while the participant is seated.
Timepoint [4] 405354 0
2 weeks post-intervention commencement
Secondary outcome [5] 405355 0
Knee extension strength using a dynamometer while the participant is seated.
Timepoint [5] 405355 0
2 weeks post-intervention commencement
Secondary outcome [6] 405726 0
Clinical assessed spasticity of the knee flexors using the Modified Tardieu Scale This scale is a standardised assessment where a therapist rates the knee flexor muscles on scale from 0-5 during a fast passive movement, where 0=no joint resistance and 5 = rigidity.
Timepoint [6] 405726 0
2 weeks post-intervention commencement
Secondary outcome [7] 405727 0
Clinical assessed spasticity of the ankle plantar flexors using the Modified Ashworth Scale. This scale is a standardised assessment where a therapist rates the ankle plantar flexor muscles on scale from 0-4, where 0=no spasticity and 4 = unable to move joint.
Timepoint [7] 405727 0
2 weeks post-intervention commencement
Secondary outcome [8] 405728 0
Self reported spasticity during Modified Ashworth test, using a 10cm visual analogue scale expressed as a line for the participant to make a mark on from 0 = no spasticity to 10 = worst spasticity experienced
Timepoint [8] 405728 0
2 weeks post-intervention commencement
Secondary outcome [9] 405729 0
Self reported spasticity during Tardieu test, using a 10cm visual analogue scale expressed as a line for the participant to make a mark on from 0 = no spasticity to 10 = worst spasticity experienced
Timepoint [9] 405729 0
2 weeks post-intervention commencement
Secondary outcome [10] 405731 0
Clinical assessed spasticity of the ankle plantar flexors using the Modified Tardieu Scale This scale is a standardised assessment where a therapist rates the ankle plantar flexor muscles on scale from 0-5 during a fast passive movement, where 0=no joint resistance and 5 = rigidity.
Timepoint [10] 405731 0
2 weeks post-intervention commencement
Secondary outcome [11] 405733 0
Passive range of motion of ankle dorsiflexion using a standard goniometer while the participant is seated.
Timepoint [11] 405733 0
2 weeks post-intervention commencement
Secondary outcome [12] 405734 0
Ankle plantarflexion strength using a dynamometer while the participant is seated.
Timepoint [12] 405734 0
2 weeks post-intervention commencement

Eligibility
Key inclusion criteria
Participants will be included if they:
• have spinal cord injury
• have spasticity, defined as scoring at least 1 on the Modified Tardieu Scale
• are able to perform the Timed Up and Go test
• do not have implanted devices (e.g. pacemaker, Baclofen pump)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will not be included if they:
• have a history of clinically significant autonomic dysreflexia in response to electrical stimulation
• have a history of hypotension in response to prolonged standing
• have a history of long-bone fracture, family history of fragility fracture or any disorders of the bone, such as Paget’s disease that prevents standing for up to 60 minutes
• have extensive lower limb contractures (limiting ROM by at least 30% within normal ranges required for ambulation)
• have any contraindications to electrical stimulation such as cardiac pacemaker, baclofen pump, pregnancy, or hardware near the stimulation site
• are actively participating in any other clinical trials or are still in the follow-up period of a clinical trial

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/02/2022
Actual
27/04/2022
Date of last participant enrolment
Anticipated
3/06/2024
Actual
Date of last data collection
Anticipated
28/06/2024
Actual
Sample size
Target
20
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 310612 0
Other
Name [1] 310612 0
Neuroscience Research Australia
Country [1] 310612 0
Australia
Primary sponsor type
Other
Name
Neuroscience Research Australia
Address
139 Barker Street
Randwick, NSW, 2031
Country
Australia
Secondary sponsor category [1] 311817 0
None
Name [1] 311817 0
Address [1] 311817 0
Country [1] 311817 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310217 0
The University of New South Wales Research Ethics Committee
Ethics committee address [1] 310217 0
Ethics committee country [1] 310217 0
Australia
Date submitted for ethics approval [1] 310217 0
Approval date [1] 310217 0
23/09/2021
Ethics approval number [1] 310217 0

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

Contacts
Principal investigator
Name 116886 0
Dr Claire Boswell-ruys
Address 116886 0
Neuroscience Research Australia 139 Barker Street Randwick, NSW, 2031
Country 116886 0
Australia
Phone 116886 0
+61 2 39331887
Fax 116886 0
Email 116886 0
[email protected]
Contact person for public queries
Name 116887 0
Claire Boswell-ruys
Address 116887 0
Neuroscience Research Australia 139 Barker Street Randwick, NSW, 2031
Country 116887 0
Australia
Phone 116887 0
+61 2 39331887
Fax 116887 0
Email 116887 0
[email protected]
Contact person for scientific queries
Name 116888 0
Claire Boswell-ruys
Address 116888 0
Neuroscience Research Australia 139 Barker Street Randwick, NSW, 2031
Country 116888 0
Australia
Phone 116888 0
+61 2 39331887
Fax 116888 0
Email 116888 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers on a case by case basis

Conditions for requesting access:
• -

What individual participant data might be shared?
• De-identified raw data for individuals and group data of published results only

What types of analyses could be done with individual participant data?
• Secondary analysis and potential pooling of data

When can requests for individual participant data be made (start and end dates)?
From:
Upon completion and publication of the trial, no end date.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• on request from principal investigator via email [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.