Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001109392p
Ethics application status
Help: Ethics application status
Submitted, not yet approved
Date submitted
Help: Date submitted
27/05/2026
Date registered
Help: Date registered
8/09/2026
Date last updated
Help: Date last updated
8/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
8/09/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
The Effects of Direct Current Stimulation Combined with Exercise on Mobility, Strength, and Balance in People with Multiple Sclerosis (MS): A Randomised Controlled Trial
Scientific title
The Effects of an 8-Week Combined Pulsed Direct Current (DC) Stimulation and Exercise Intervention on Lower Limb Strength, Balance, and Functional Mobility Outcomes in Adults with Multiple Sclerosis: A Parallel-Group, Single-Blinded Randomised Controlled Trial
Additional trial identifiers [1] 317390 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Multiple Sclerosis 342050 0
Condition category
Condition code
Neurological 338144 338144 0 0
Multiple sclerosis
Physical Medicine / Rehabilitation 338732 338732 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Arm 1 — Combined DC Stimulation and Exercise (Intervention)Arm 1 — Combined DC Stimulation and Exercise (Intervention)
Participants will complete a supervised exercise program twice weekly for 8 weeks (16 sessions total), each session lasting approximately 45–60 minutes. Sessions will be delivered one-on-one in a face-to-face format at the ACU Exercise and Lifestyle Clinic, Strathfield Campus, by qualified exercise science researchers.
The program comprises progressive resistance and functional training targeting lower limb strength, balance, and mobility, individualised according to participant capacity. Examples of exercises prescribed include leg press, leg extension, seated hamstring curl, hip flexion and abduction using a terminal hip machine, step-ups, and balance and gait retraining. Exercise intensity will be set at a moderate-to-vigorous level, monitored using the RPE scale (0–10), targeting a rating of 6–7 (hard), with a Repetitions in Reserve (RIR) of 2–3. Intensity will be progressively increased across the 8 weeks in accordance with each participant's tolerance and functional response.
During exercise, pulsed direct current (DC) stimulation will be delivered via the Neubie device , applied bilaterally to lower limb musculature including the tibialis anterior, gastrocnemius, quadriceps (rectus femoris and vastus medialis), and hamstrings. Stimulation intensity will be individualised and titrated to a subjective intensity of 7/10 on a verbal rating scale, and will not exceed a VAS-Pain ceiling of greater than 4/10. Stimulation frequency will be periodised across the 8-week program: Stimulation frequency will be periodised across the 8-week program: Weeks 1–2 will use 100–160 pps to prioritise neuromuscular re-education and device adaptation, Weeks 3–5 will use 55–75 pps to maximise muscle activation for strength and hypertrophy, and Weeks 6–8 will use 40–75 pps to support progressive overload as training demands increase.
Adherence will be monitored via session attendance checklists completed by the researcher at each visit, with attendance recorded as a proportion of the 16 scheduled sessions. Reasons for any missed sessions will be documented. Participants missing more than two consecutive sessions will be contacted to confirm continued eligibility and willingness to proceed.
Intervention code [1] 334181 0
Treatment: Devices
Intervention code [2] 334182 0
Rehabilitation
Intervention code [3] 334183 0
Treatment: Other
Description of the comparator or control
Arm 2 — Exercise Only (Control)
Participants will complete the identical supervised exercise program twice weekly for 8 weeks (16 sessions total) without DC stimulation. The sole difference between groups is the absence of Neubie stimulation.

Exercise-only program, identical in frequency, duration, and content to the intervention group, delivered without DC stimulation. 16 sessions over 8 weeks, approximately 45–60 minutes per session, face-to-face at ACU Strathfield Campus.
Control group
Active

Outcomes
Primary outcome [1] 345531 0
Change in walking speed
Timepoint [1] 345531 0
Timepoint: Baseline (Week 0, prior to commencement of intervention), Week 4 (mid-intervention), Week 8 (post-intervention, primary timepoint), Week 14 (6-week post-intervention follow-up)
Primary outcome [2] 345532 0
Lower limb functional strength
Timepoint [2] 345532 0
Timepoint: Baseline (Week 0, prior to commencement of intervention), Week 4 (mid-intervention), Week 8 (post-intervention, primary timepoint), Week 14 (6-week post-intervention follow-up)
Primary outcome [3] 345533 0
Change in functional mobility
Timepoint [3] 345533 0
Timepoint: Baseline (Week 0, prior to commencement of intervention), Week 4 (mid-intervention), Week 8 (post-intervention, primary timepoint), Week 14 (6-week post-intervention follow-up)
Secondary outcome [1] 462044 0
Change in balance
Timepoint [1] 462044 0
Timepoint: Baseline (Week 0, prior to commencement of intervention), Week 4 (mid-intervention), Week 8 (post-intervention, primary timepoint), Week 14 (6-week post-intervention follow-up)
Secondary outcome [2] 462045 0
Lower limb muscle strength
Timepoint [2] 462045 0
Timepoint: Baseline (Week 0, prior to commencement of intervention), Week 4 (mid-intervention), Week 8 (post-intervention, primary timepoint), Week 14 (6-week post-intervention follow-up)
Secondary outcome [3] 462046 0
MS-related quality of life
Timepoint [3] 462046 0
Timepoint: Baseline (Week 0, prior to commencement of intervention), Week 4 (mid-intervention), Week 8 (post-intervention, primary timepoint), Week 14 (6-week post-intervention follow-up)
Secondary outcome [4] 462047 0
Change in fatigue
Timepoint [4] 462047 0
Timepoint: Baseline (Week 0, prior to commencement of intervention), Week 4 (mid-intervention), Week 8 (post-intervention, primary timepoint), Week 14 (6-week post-intervention follow-up)
Secondary outcome [5] 462048 0
Change in spasticity
Timepoint [5] 462048 0
Timepoint: Baseline (Week 0, prior to commencement of intervention), Week 4 (mid-intervention), Week 8 (post-intervention, primary timepoint), Week 14 (6-week post-intervention follow-up)
Secondary outcome [6] 462049 0
Device usability - intervention group only
Timepoint [6] 462049 0
Week 8 (post-intervention, primary timepoint), Week 14 (6-week post-intervention follow-up)
Secondary outcome [7] 462050 0
Participant comfort and perceived benefit - intervention only
Timepoint [7] 462050 0
Week 8 (post-intervention, primary timepoint), Week 14 (6-week post-intervention follow-up)
Secondary outcome [8] 463856 0
Primary outcome: walking capacity
Timepoint [8] 463856 0
Timepoint: Baseline (Week 0, prior to commencement of intervention), Week 4 (mid-intervention), Week 8 (post-intervention, primary timepoint), Week 14 (6-week post-intervention follow-up)

Eligibility
Key inclusion criteria
Confirmed diagnosis of Multiple Sclerosis (McDonald criteria)
Expanded Disability Status Scale (EDSS) score equal to or below 6.0
Able to participate in supervised exercise training
Stable disease course (no relapse within the preceding 3 months)
No contraindications to electrical stimulation or exercise
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
EDSS score >6.5
MS relapse within the preceding 3 months
Contraindications to electrical stimulation (e.g. pacemaker, active implanted devices, open wounds at electrode sites)
Contraindications to exercise participation
Inability to provide informed consent

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)
Central randomisation by computer-generated sequence; allocation concealed from assessors
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation with stratified permuted block randomisation, stratified by baseline functional capacity
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2027
Actual
Date of last participant enrolment
Anticipated
1/03/2028
Actual
Date of last data collection
Anticipated
1/06/2028
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 321963 0
University
Name [1] 321963 0
Australian Catholic University
Country [1] 321963 0
Australia
Funding source category [2] 321964 0
Commercial sector/Industry
Name [2] 321964 0
Apex Health Movement
Country [2] 321964 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
Country
Australia
Secondary sponsor category [1] 324837 0
Commercial sector/Industry
Name [1] 324837 0
Apex Health Movement
Address [1] 324837 0
Country [1] 324837 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 320501 0
ACU Human Research Ethics Committee
Ethics committee address [1] 320501 0
Ethics committee country [1] 320501 0
Australia
Date submitted for ethics approval [1] 320501 0
08/05/2026
Approval date [1] 320501 0
Ethics approval number [1] 320501 0

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

Contacts
Principal investigator
Name 150674 0
Prof Michael Cole
Address 150674 0
1100 Nudgee Road, Banyo, QLD, 4014, Australian Catholic University
Country 150674 0
Australia
Phone 150674 0
+61 7 3623 7674
Fax 150674 0
Email 150674 0
[email protected]
Contact person for public queries
Name 150675 0
Michael Cole
Address 150675 0
1100 Nudgee Road, Banyo, QLD, 4014, Australian Catholic University
Country 150675 0
Australia
Phone 150675 0
+61 7 3623 7674
Fax 150675 0
Email 150675 0
[email protected]
Contact person for scientific queries
Name 150676 0
Michael Cole
Address 150676 0
1100 Nudgee Road, Banyo, QLD, 4014, Australian Catholic University
Country 150676 0
Australia
Phone 150676 0
+61 7 3623 7674
Fax 150676 0
Email 150676 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Informed consent form    Information and consent form for study PICF Study 3_SUBMISSION.pdf


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.