Effects of Robotic Neurorehabilitation With Lokomat on Physiological Responses in Neurological Patients: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Interventional Study
- Sponsor
- IRCCS Centro Neurolesi "Bonino-Pulejo"
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Delta of variation in maximum and minimum blood pressure
- Last Updated
- 6 years ago
Overview
Brief Summary
Robotic rehabilitation is very useful for improving functional recovery in neurological patients, there is not much evidence on its role in improving physiological responses (i.e. intestinal motility, orthostatic pressure), which are often abnormal in these patients.
To this end, we designed a randomized controlled experimental study on neurological patients, with the aim of evaluating the effects of robotic neurorehabilitation using Lokomat on physiological responses, compared to traditional therapy.
Investigators
Rocco Salvatore Calabrò
Medical Director, Neurologist
IRCCS Centro Neurolesi "Bonino-Pulejo"
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Delta of variation in maximum and minimum blood pressure
Time Frame: 8 months
Orthostatic pressure derives from systolic pressure and / or diastolic blood pressure (BP) (about 10 mm / Hg) from supine to vertical. It is evaluated by delta of variation in maximum and minimum blood pressure.
Constipation Scoring System
Time Frame: 8 months
Constipation Scoring System (CSS) is an eight-element self-report measure designed to assess the prevalence and severity of constipation. The authors used a pathophysiological definition of constipation. The scoring system is based on eight variables (frequency of bowel movements; difficult or painful evacuation; completeness of evacuation; abdominal pain; time per attempt; assistance including laxatives; digits or enemas; number of failed evacuation attempts in a period of 24 hours and duration of constipation). The CSS consists of seven objects that are marked using a five-point Likert scale ranging from 0 (no time) to 4 (all the time) and an article evaluated on a 0-2 scale. A total score can range from 0 (normal) to 30 (severe constipation). A limit score of 15 suggests constipation.
Secondary Outcomes
- Functional Independence Measure(8 months)
- The 12-Item Short Form Health Survey(8 months)