About this trial
To determine whether the combination of non-invasive spinal cord stimulation together with gait rehabilitation reduces spasticity and facilitates recovery of lower limb motor strength and gait function in patients with incomplete SCI, as well as studying the underlying physiopathological changes following incomplete SCI and its modulation by non-invasive stimulation techniques.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female more than 18 years old;
With a stable traumatic o nor traumatic incomplete motor cervical or thoracic SCI;
Time since SCI more than 6 months;
American Spinal Injury Association Impairment Scale (AIS)-D who could realize gait at least 6 meters with or without technical help;
Disqualifiers
Unstable medical condition (cancer, acute infections, etc.);
Severe spasticity (≥ 3 score on the Modified Ashworth scale (MAS)),
Peripheral nerve affectation;
Ulcers on the electrode applied area;
Trial design
Sequential
Treatments tested in this trial
transcutaneous spinal cord stimulation
DeviceThis study consisted of: (i) baseline condition; and (ii) tSCS conditions: which consisted of 7 different combinations applied to different segments of the spinal cord in the randomized order: C5, L1, Coc1, C5+L1, C5+Coc1, L1+Coc1, C5+L1+Coc1 and than (iii) final condition: Individuals with SCI realized all clinical assessment after the last condition of tDCSs. We included the final control condition to ensure the reliability of our findings. Baseline, tSCSs, and final control conditions were conducted as part of three assessments: the 6MWT and MVC-QM and MVC-TA, Hmax/Mmax ratio.
Treatment groups
Trial outcomes
Primary outcomes
6MWT
6 METER WALKING TEST
Secondary outcomes
MVC
Maximum voluntary contraction
Hmax\Max ratio
Sponsors and contacts
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