Multiple Sclerosis Clinical Trial
Official title:
A Task-oriented Circuit Training in Multiple Sclerosis: a Multicentric Randomized Controlled Trial
Our primary hypothesis is that a two weeks high-intensity task-oriented circuit training
followed by a structured 3 months home exercise program would have higher benefits compared
to a delayed-treatment group as control in people with multiple sclerosis and mild to
moderate gait impairment.
Our secondary hypothesis is that there could be retention of clinical gains in subjects that
underwent TOCT plus structured 3 months home exercise program.
This is a single blind randomized-controlled trial to test the effects of a task oriented
training on locomotor function, mobility and balance in multiple sclerosis subjects with mild
to moderate gait impairments (EDSS 4-5.5).
Subjects and methods:54 multiple sclerosis patients will be recruited in two outpatient
rehabilitation clinics (Azienda Ospedaliero- Universitaria di Ferrara and Azienda
Ospedaliero-Universitaria Pisana). Informed consent will be obtained. Participants enrolled
will be included in 2 different treatment groups: experimental group will receive 10 TOCT
sessions over 2 weeks (2 hours/each session) followed by a 3 months home exercise program,
whereas control group will be included into a delayed-treatment group. Three subjects with a
supervisor physiotherapist will take part at the TOCT. Primary outcome measure will be
walking endurance (Six Minute Walking Test); as secondary outcome we will test gait speed
(Timed 25-Foot Walk), balance (Dynamic Gait Index) and mobility (Time Up and Go Test);
through self-assessment questionnaires we will evaluate motor fatigue (Modified Fatigue
Impact Scale - MFIS), walking ability (Multiple Sclerosis Walking Scale - 12), health-related
quality of life (Multiple Sclerosis Impact Scale - 29 and Functional Assessment of Multiple
Sclerosis). In addition to clinical outcomes, in a convenience sample we will have: (i)
balance assessment (force platform); (ii) motorcortex oxygenation during walking (fNIRS);
(iii) muscle oxygenation (NIRS); (iv) force and EMG signal; (v) mechanical and electrical
fatigue assessment; (vi) brain connectivity (EEG). Outcome measures will be assessed 1 week
prior to treatment initiation (T0), after two weeks to treatment initiation (T1), after the 3
months exercise program (T2) and at 3 months follow-up (T3) to evaluate treatments retention,
by a clinician blinded to the treatment.
The specific aims will be (i) to test the effects on walking, mobility, balance, fatigue and
health-related quality of life; (ii) to test the effects on cerebral oxygenation (fNIRS)
during walking; (iii) muscle oxygenation (NIRS); (iv) force and EMG signal; (v) Mechanical
and electrical fatigue assessment; (vi) brain connectivity (EEG) and (vii) to investigate the
3 months home exercise program's feasibility, satisfaction and adherence.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05528666 -
Risk Perception in Multiple Sclerosis
|
||
Completed |
NCT03608527 -
Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis
|
N/A | |
Recruiting |
NCT05532943 -
Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis
|
Phase 1/Phase 2 | |
Completed |
NCT02486640 -
Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
|
||
Completed |
NCT01324232 -
Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis
|
Phase 2 | |
Completed |
NCT04546698 -
5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis
|
||
Active, not recruiting |
NCT04380220 -
Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
|
||
Completed |
NCT02835677 -
Integrating Caregiver Support Into MS Care
|
N/A | |
Completed |
NCT03686826 -
Feasibility and Reliability of Multimodal Evoked Potentials
|
||
Recruiting |
NCT05964829 -
Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis
|
N/A | |
Withdrawn |
NCT06021561 -
Orofacial Pain in Multiple Sclerosis
|
||
Completed |
NCT03653585 -
Cortical Lesions in Patients With Multiple Sclerosis
|
||
Recruiting |
NCT04798651 -
Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis
|
N/A | |
Active, not recruiting |
NCT05054140 -
Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis
|
Phase 2 | |
Completed |
NCT05447143 -
Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis
|
N/A | |
Recruiting |
NCT06195644 -
Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients
|
Phase 1 | |
Completed |
NCT04147052 -
iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis
|
N/A | |
Completed |
NCT03594357 -
Cognitive Functions in Patients With Multiple Sclerosis
|
||
Completed |
NCT03591809 -
Combined Exercise Training in Patients With Multiple Sclerosis
|
N/A | |
Completed |
NCT02845635 -
MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis
|