Finished
Association Between tDCS and Lokomat Training in Patients With Incomplete Spinal Cord Injury
NCT02562001 · University of Sao Paulo General Hospital · Updated 8 June 2021
- What is being tested
- Outpatient active group; Outpatient placebo group; Inpatient active group; Inpatient placebo group
- For
- Spinal Cord Injuries
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years to 65 years. About 42 people. The full rules are on the registry page.
- Where
- Brazil
- When
- Starts or started 6 May 2015, ends 5 May 2018. Registered 29 Sept 2015.
- Results
- None posted yet.
In the researchers' words
The spinal cord injury is identified as the major cause of permanent disability worldwide, with the loss of ability to walk being the largest and most devastating of them for these patients. Our goal is to analyze the effects of electrical transcranial direct-current stimulation (tDCS) combined with gait training with partial body weight support aided by robotic device (Lokomat, Hocoma) in the gait of patients with incomplete spinal cord injury (SCI). In this stratified randomized double-blind study, the participants will be randomly allocated into one of both groups, outpatients (GA) or inpatients (GI), and will receive active or placebo tDCS followed by gait training with Lokomat (GA: 3 sessions/week x 10 weeks = 30 sessions; GI: 5 sessions/week x 6 weeks = 30 sessions). The functional assessments (through clinical and functional scales, assess gait, muscle strength, spasticity, balance and pain) and neurophysiological (cortical excitability measured by transcranial magnetic stimulation, electroencephalography and functional near-infrared spectroscopy) will be held before and after the training period. The functional assessments will be also held after 15 sessions (intermediate) and after 3 months follow up. The expected result is that patients that received the active tDCS presents an improvement over the ground gait after the Lokomat training period significantly greater…
Sites
- Instituto de Medicina Física e Reabilitação, Hospital das Clínicas, Faculdade de Medicina da Universidade de São PauloSão Paulo, Brazil
