Physiological Responses in Robotic Neurorehabilitation

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Robotic Neurorehabilitation With Lokomat on Physiological Responses in Neurological Patients: a Randomized Controlled Trial

Conditions
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Interventional Study

Intervention / Treatment
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* Other: Robotic Treatment
* Other: Conventional Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: diagnosis of neurological disease; age between 18 and 75; and Caucasian ethnicity; a FIM motor score equal to or greater than 30. Exclusion criteria: patients with a history of concomitant brain surgery; severe cognitive or language impairment; systemic, bone or joint disorders; presence of disabling sensory alterations; concomitant medical and psychiatric illness that could interfere with VR training.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study is a parallel-group randomized clinical trial using a double-blind study design. The enrolled patients will be randomly assigned to the 2 groups using an automated computerized randomization program. Patients will be informed about the research and will be asked to fill in the informed consent form. The patient's basic characteristics (age, sex, duration of the illness, marital status and educational background) will be recorded. Randomization will be performed using a randomization list, so patients will be randomized in a 1:1 ratio in the intervention or control group.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic Treatment<br>The Lokomat is a robotic device. For treatment with the robotic system, the amount of body weight supported will initially set at 70% of every patient's weight, then decreasing in accordance with load tolerance, although not providing less than 20% support. The selected speed will be adapted to the patient's working comfort under the supervision of a trained physiotherapist. The rehabilitation protocol consists of 40 training sessions (3 sessions per week lasting 45 minutes). | Other: Robotic Treatment<br>* The Lokomat is a robotic device, consisting of a powered gait orthosis with integrated computer-controlled linear actuators at each hip and knee joint, a body weight support, and a treadmill. During the Lokomat training, the patients completed at least 30 min of treatment session.<br>* Other names: Lokomatdevice;|
| Active Comparator: Conventional Treatment<br>The CG will perform traditional overgroung gait rehabilitation. Exercises in this program are designed with gradual increments to meet each patient's abilities and were supervised by a physical therapist. The rehabilitation protocol consists of 40 training sessions (3 sessions per week lasting 45 minutes). | Other: Conventional Treatment<br>* The standard physical treatment program consisted of general conditioning exercises, including warming up (e.g. calf, shoulder, and hand passive range of motion exercises), lower and upper extremity strengthening, postural control exercises. During the conventional training, the patients completed at least 30 min of treatment session.<br>* Other names: control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constipation Scoring System | 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. | 8 months | 
| Delta of variation in maximum and minimum blood pressure | 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. | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 12-Item Short Form Health Survey | The SF-12 Health Survey (SF-12) is a 12-article questionnaire used to assess general health outcomes from a patient's perspective. SF-12 assesses health-related quality of life, including the impact of all diseases on a wide range of functional domains. SF-12 consists of a subset of 12 articles dealing with physical functioning, physical role, physical pain, general health, vitality, social functioning, emotional role and mental health. | 8 months | 
| Functional Independence Measure | The FIM scale is a questionnaire that evaluates 18 activities of daily life (13 motor-sphincteric, 5 cognitive). Each activity can receive a variable score between 1 (complete dependence on others) and 7 (complete self-sufficiency). The cumulative score and the profile of the scores in the different items represent standard indicators that are now very common in the world of rehabilitation. The applications range from the measurement of the appropriateness and effectiveness of the rehabilitation intervention on the individual case, to the forecast of hospitalization times, care interviews and health costs in single operational units or on the network, or in longitudinal path rehabilitation studies. The cumulative scores produce a quantitative index of the person's disability. | 8 months |