Physiological Responses in Robotic Neurorehabilitation

NCT04035122 | Unknown

• 1 other identifier: IRCCSME:15/2019
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Interventional Study

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• The 12-Item Short Form Health Survey

  8 months

• Functional Independence Measure

  8 months

Study Arms (2)

Robotic Treatment

EXPERIMENTAL

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

Conventional Treatment

ACTIVE COMPARATOR

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

Interventions

Robotic Treatment OTHER

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.

Also known as: Lokomatdevice

Robotic Treatment

Conventional Treatment OTHER

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.

Also known as: control group

Conventional Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

Study Sites (1)

IRCCS Neurolesi

Messina, Sicily, 98124, Italy

RECRUITING

Related Publications (2)

• 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.

  PMID: 28477702 RESULT

• 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.

  PMID: 26781943 RESULT

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Rocco S Calabrò, MD

  IRCCS Centro Neurolesi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rocco S Calabrò, MD

CONTACT

+3909060128166; salbro77@tiscali.it

Rossella Ciurleo, PhD

CONTACT

+3909060128109; rosella.ciurleo@irccsme.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomization list is blind to anyone involved in informing potential study participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Neurologist

Model Details: 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.

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: July 29, 2019
• Study Start: August 1, 2019
• Primary Completion: May 31, 2020
• Study Completion: July 31, 2020
• Last Updated: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)