Physiological Responses in Robotic Neurorehabilitation (Lokophysio)

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

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.

Study Overview

• Status: Unknown
• Conditions: Interventional Study
• Intervention / Treatment: Other: Robotic Treatment; Other: Conventional Treatment

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Sicily
    • Messina, Sicily, Italy, 98124
      • Recruiting
      • IRCCS Neurolesi
      • Contact: Rocco S Calabrò

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robotic Treatment; 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; 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.; Other Names: Lokomatdevice
Active Comparator: Conventional Treatment; 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; 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.; Other Names: control group

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: IRCCS Centro Neurolesi "Bonino-Pulejo"
• Investigators: Principal Investigator: Rocco S Calabrò, MD, IRCCS Centro Neurolesi

Publications and helpful links

General Publications

• Calabro RS, Russo M, Naro A, De Luca R, Leo A, Tomasello P, Molonia F, Dattola V, Bramanti A, Bramanti P. Robotic gait training in multiple sclerosis rehabilitation: Can virtual reality make the difference? Findings from a randomized controlled trial. J Neurol Sci. 2017 Jun 15;377:25-30. doi: 10.1016/j.jns.2017.03.047. Epub 2017 Mar 29.
• Calabro RS, Cacciola A, Berte F, Manuli A, Leo A, Bramanti A, Naro A, Milardi D, Bramanti P. Robotic gait rehabilitation and substitution devices in neurological disorders: where are we now? Neurol Sci. 2016 Apr;37(4):503-14. doi: 10.1007/s10072-016-2474-4. Epub 2016 Jan 18.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Anticipated): May 31, 2020
• Study Completion (Anticipated): July 31, 2020

Study Registration Dates

• First Submitted: July 25, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (Actual): July 29, 2019

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 14, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: IRCCSME:15/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No