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The Effects of Direct Current Stimulation Combined with Exercise on Mobility, Strength, and Balance in People with Multiple Sclerosis (MS): A Randomised Controlled Trial

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626001109392
Enrollment
40
Registered
2026-09-08
Start date
2027-01-01
Completion date
2028-03-01
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study investigates whether adding pulsed direct current (DC) electrical stimulation, delivered via the Neubie device, to a supervised exercise program produces greater improvements in walking ability, strength, and balance in adults with Multiple Sclerosis (MS) compared with exercise alone. Forty participants will be randomly allocated to either 8 weeks of combined DC stimulation and exercise, or exercise alone. Assessments will occur at baseline, mid-intervention, post-intervention, and at a 6-week follow-up to determine whether any improvements are maintained over time. Findings will inform whether this combined approach offers a practical and effective rehabilitation strategy for people with MS.

Interventions

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

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.

Sponsors

Australian Catholic University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Sep 19, 2026