Finished
Effects of Combined Treatment by Botulinum Toxin and Lokomat® on Walking Ability in Chronic Stroke
NCT03659266 · Assistance Publique Hopitaux De Marseille · Updated 14 June 2024
- What is being tested
- Robotic walking rehabilitation by Lokomat®; Conventional walking rehabilitation
- For
- Stroke
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. About 34 people. The full rules are on the registry page.
- Where
- France
- When
- Starts or started 7 March 2019, ends 2 July 2021. Registered 6 Sept 2018.
- Results
- None posted yet.
In the researchers' words
75% patients in the chronic phase of a stroke keep walking disabilities. Focal spasticity in the paretic lower limb frequently causes these walking disabilities, and the gold standard treatment is intramuscular injection of Botulinum toxin A in the spastic muscles. To potentiate the effects of toxin, walking rehabilitation is usually prescribed in the weeks following injection, but the protocols vary and few have been evaluated in the medical literature. In particular, the effect on walking ability of combined treatment by botulinum toxin A and robot-assisted gait training has never been evaluated. Tested hypothesis: Robot-assisted gait training by Lokomat® motorized exoskeleton potentiates botulinum toxin's effects better than conventional walking therapy. The aim of this study was to evaluate the effects on walking ability of the association of focal spasticity treatment by Botulinum toxin and Lokomat-assisted walking rehabilitation in patients suffering from spastic hemiparesia after stroke in the chronic phase. Outcome: -Primary: distance walked (meters) in the six-minute walk test (SMWT) Prospective, randomized, controlled, opened, monocentric study with a crossover design. Recruitment of patients over 18 years of age, in the chronic phase of stroke, who have already been treated by Botulinum toxin injection for focal spasticity in our PMR ward. Assessment at Day…
Sites
- Assistance Publique Des Hopitaux de MarseilleMarseille, PACA, France
