Physiological Responses in Robotic Neurorehabilitation

Not Applicable

• Conditions: Interventional Study
• Interventions: Other: Conventional Treatment; Other: Robotic Treatment

• Registration Number: NCT04035122
• Lead Sponsor: IRCCS Centro Neurolesi "Bonino-Pulejo"

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-25
• Study First Submitted QC: 2019-07-25
• Study First Posted: 2019-07-29
• Study Start: 2019-08-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-14
• Last Update Posted: 2020-02-17
• Primary Completion: 2020-05-31
• Study Completion: 2020-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Treatment	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).
Robotic Treatment	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).

Primary Outcome Measures

Name	Time	Method
Delta of variation in maximum and minimum blood pressure	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	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 Outcome Measures

Name	Time	Method
Functional Independence Measure	8 months	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.
The 12-Item Short Form Health Survey	8 months	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.

Trial Locations

Locations (1)

IRCCS Neurolesi; 🇮🇹 Messina, Sicily, Italy