Spasticity, Ziclague, Hereditary Spastic Paraplegia
Conditions
Interventions
Experimental arm:
27 patients. Daily dermal administration of 02 "Alpinia zrumbet" essential oil (Ziclague®) sprays of 0,2 ml over adductors, quadriceps femoris, hamstrings and triceps surae muscles b
Drug
Sponsors
Universidade Estadual de Campinas (UNICAMP)
Universidade Estadual de Campinas (UNICAMP)
Indústria Química Farmacêutica Nacional S/A (INFAN)
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Age between 18 and 80 years old. Clinical diagnosis of Hereditary Spastic Paraplegia. Ability to walk out of home. Assistive devices are permitted
Exclusion criteria
Exclusion criteria: Wheelchair bound patients. Additional neurological symptoms that may significantly impact gait such as ataxia, lower motor neuron disease, polyneuropathy, mental retardation or dementia. Fixed tendon contractures. Current botulinum toxin injection or in the last six months. Pregnants or breastfeeding. Refusal to consent form. Skin infection or inflammation at site of interest.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change from baseline in 10 meter maximum gate velocity [Time Frame: 4 weeks after the start of daily dermal administration] The primary outcome measure will be change from baseline in maximum gait velocity. Each patient will be asked to walk a 10 meter distance barefooted 3 times, as fast as he can. The average velocity between the 3 trials will be used as the final measure. Assistive devices are permitted | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change from baseline in 10 meter comfortable walking velocity [Time Frame: 4 weeks after the start of daily dermal administration] Each patient will be asked to walk a 10 meter distance barefooted 3 times, as comfortable as possible for him. The average velocity between the 3 trials will be used as the final measure. Assistive devices are permitted 2. Change from baseline in 6 minutes walk test [Time Frame: 4 weeks after the start of daily dermal administration] Each patient will be asked to walk a 30 meters distance barefooted for 6 minutes 2 times, at a speed was comfortable for him. The average velocity between the 2 trials will be used as the final measure. Assistive devices are permitted 3. Change from baseline in gait parameters (cadence and stride length) [Time Frame: 4 weeks after the start of daily dermal administration] This measures will be assessed by a neurologic physiotherapist 4. Change from baseline in Spastic Paraplegia Rating Scale (SPRS) [Time Frame: 4 weeks after the start of daily dermal administration] The same neurologist will examine the patient to evaluate change at the SPRS scale 5. Change from baseline in modified Ashworth spasticity scale of adductors, quadriceps femoris, hamstrings and triceps surae muscles bilaterally [Time Frame: 4 weeks after the start of daily dermal administration] The same neurologist will examine the patient to evaluate change from baseline 6. Change from baseline in muscle strengh (Medical Research Council scale) concerning adductors, quadriceps femoris, hamstrings and triceps surae muscles bilaterally [Time Frame: 4 weeks after the start of daily dermal administration] The same neurologist will examine the patient to evaluate change from baseline 7. Change from baseline in visual analogic scale of pain [Time Frame: 4 weeks after the start of daily dermal administration] This scale will be applied by a neurologic physiotherapist 8. Change from baseline in brief pain inventory scale [Time F | — |
Countries
Brazil
Contacts
Public ContactMarcondes França Junior
University of Campinas
Outcome results
None listed