Gait
Conditions
Interventions
This is a randomized, double-blind, crossover, pilot clinical trial with 10 volunteer participants. Participants will be equally divided and randomly assigned to Group A or Group B. Group A: people ov
they will receive 1 cycle of trans-spinal stimulation associated with treadmill training for 5 consecutive days (intervention phase), followed by no exercise for 4 weeks (washout period), and then rec
will receive 3 cycles of stimulation (20 trains, 20 bursts, and each burst will have 3 pulses at 50 Hz repeated at 5Hz) associated with treadmill training, for 5 consecutive days (intervention phase)
Sponsors
Universidade Federal da Paraíba
Universidade Federal da Paraíba
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Men and women between 18 and 80 years old; people with Parkinson's Disease (PD) in Hoehn Yahr stages between 2 and 4 (moderate disease) whose primary symptom includes gait alteration; being able to walk independently for 30 meters or with a unilateral assistive device; having a Mini-Mental State Examination (MMSE) score greater than or equal to 24 for people with more than 8 years of schooling and above 20 points for illiterate people
Exclusion criteria
Exclusion criteria: Unstabilized psychiatric comorbidities; other neurological disorders, musculoskeletal, orthopedic, cardiovascular, and respiratory changes that may affect the ability to walk on the treadmill; labyrinthine problems; deep brain stimulation surgery or epidural stimulation of the spinal cord; uncontrolled infection or other uncontrolled pre-existing medical conditions (e.g. uncontrolled infection or other uncontrolled pre-existing medical conditions (e.g. decompensated diabetes, hypertension, symptomatic lung or heart disease); concomitant treatment with other experimental drugs; pregnant or breastfeeding women; chronic low back and lower limb pain; not walking without an aid (cane, crutch, walker) or help from another person; metal implants and cardiac pacemakers; history of neurosurgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We expected to find a change in gait speed between the pre-stimulation and post-stimulation conditions between the two groups, as assessed by the 10-meter walk test (fast speed), of at least 5%. | — |
Secondary
| Measure | Time frame |
|---|---|
| We expected to find a change in functional mobility between the pre-stimulation and post-stimulation conditions between the two groups, as assessed by the Timed Up and Go Test, of at least 5%.;It is expected to find a change in dynamic balance performance between the pre-stimulation and post-stimulation conditions between the two groups assessed through the Mini-Balance Evaluation Systems Test (Mini-BESTest), of at least 5%.;We expected to find a change in the perception of quality of life between the pre-stimulation and post-stimulation conditions between the two groups, as assessed by the Parkinson's Disease Questionnaire (PDQ-39), of at least 5%. | — |
Countries
Brazil
Contacts
Public ContactMaria Luísa Gomes
Universidade Federal da Paraíba
Outcome results
None listed