The Use of Modern Technologies in Neurorehabilitation

NCT05550987 | Unknown

• 1 other identifier: Neurorehabilitation
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

Early conventional rehabilitation improves the functioning of patients with neurological diseases. However, recovery is not always satisfactory. These needs are met by the constantly developing modern technologies supporting the process of neurorehabilitation. The main goal of the research project is to evaluate the use of modern technologies in the rehabilitation of patients with neurological diseases (after stroke, craniocerebral trauma, spinal cord injury, cerebral palsy and multiple sclerosis). According to the research hypothesis, intensive rehabilitation with the use of modern technologies will improve the functional efficiency of patients with neurological diseases.

Conditions

Neurorehabilitation; Nervous System Diseases; Biomedical Enhancement; Physical Activity

Keywords

Exercise Therapy; Neurological Rehabilitation,; Recovery of Function

Outcome Measures

Primary Outcomes (5)

• An assessment of static and dynamic balance using Berg Balance Scale (BBS)

  Assessment of static and dynamic balance based on 14 types of movement in the standing and sitting position of the patient. Each task of the test is scored using a four-point scale. A maximum score of 56 points is possible. Patients with a score below 20 pts indicate high risk of fall and the need of using wheelchairs.

  at baseline, immediately after treatment

• An assessment of locomotor stages after Spinal Cord Injury using LOSSCI Scale

  The LOSSCI is a five-stage scale result of applying and adapting to spinal cord injury the original Vojta's 10 specific locomotor stages. Each LOSSCI stage should be evaluated in ascending order and the grading is determined by the highest stage the person can accomplish: orienting to and touching or grasping an object in supine position, trunk uprighting in prone position, creeping, crawling or walking support for the upper limbs, independent bipedal locomotion. The person's highest stage is reached when at least one item in a stage is achieved.

  at baseline, immediately after treatment completion

• An assessment of trunk movement using The Trunk Control Test for Motor Impairment After Stroke (TCT)

  The TCT examines four axial movements: rolling from a supine position to the weak side and to the strong side, sitting up from a lying-down position, and sitting in a balanced position on the edge of the bed with feet off the ground for 30 seconds. The scoring is as follows: 0, unable to perform movement without assistance; 12, able to perform movement but in an abnormal manner; and 25, able to complete movement normally. The TCT score is the sum of the scores obtained on the four tests (range, 0 to 100).

  at baseline, immediately after treatment completion

• An assessment of fall risk using Timed Up and Go Test (TUG)

  Measurement of the time in seconds for a person to rise from sitting from a standard arm chair, walk 3 meters, turn, walk back to the chair, and sit down.

  at baseline, immediately after treatment completion

• An assessment of motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale

  Fugl-Meyer Motor Assessment Scale for Upper Extremity is a comprehensive tool enabling measurement of motor function; it comprises 33 motor tasks, designed to assess general movements, precision movements, grip, coordination and speed. It is also possible to perform H subgroup tests - assessing superficial and deep sensibility, and J subgroup tests - for range of passive motion and pain induced by such movements. Individual tasks are assessed on a scale 0-2 0 - impossible task. The higher the score, the better.

  at baseline, immediately after treatment completion

Secondary Outcomes (14)

• An assessment of muscle tone using modified Tardieu Scale

  at baseline, immediately after treatment completion

• An assessment of the parameters describing the center of pressure of the feet for measurements with eyes open and closed carried out on the stabilometric platform ALFA

  at baseline, immediately after treatment completion

• An assessment of strength and quality of grips carried out on the Pablo

  at baseline, immediately after treatment completion

• Analysis of gait spatiotemporal parameters carried out on Zebris

  at baseline, immediately after treatment completion

• Analysis of isometric muscle strength carried out on RoboGait

  at baseline, immediately after treatment completion

Other Outcomes (2)

• An assessment of cognitive state using The abbreviated mental test score (AMTS)

  at baseline, immediately after treatment completion

• An assessment of anxiety and depression using Hospital Anxiety and Depression Scale (HADS)

  at baseline, immediately after treatment completion

Study Arms (6)

Vibramoov Device

EXPERIMENTAL

Rehabilitation program with the use of mechanical vibration using the Vibramoov device and conventional physiotherapy

Other: Control Group

Ekso GT exoskeleton Device

EXPERIMENTAL

Rehabilitation program with gait training using the Ekso GT exoskeleton and conventional physiotherapy

Other: Control Group

RoboGait Device

EXPERIMENTAL

Rehabilitation program with the use of gait training with the use of a RoboGait stationary robot and conventional physiotherapy.

Other: Control Group

ZEBRIS Device

EXPERIMENTAL

Rehabilitation program with the use of gait training with the use of the ZEBRIS treadmill and conventional physiotherapy

Other: Control Group

PABLO Device

EXPERIMENTAL

Rehabilitation program with the use of upper limb function training with the use of the PABLO device and conventional physiotherapy

Other: Control Group

Control Group

EXPERIMENTAL

Rehabilitation program with conventional physiotherapy

Other: Rehabilitation program with the use of mechanical vibration using the Vibramoov device and conventional physiotherapy; Other: Rehabilitation program with gait training using the Ekso GT exoskeleton and conventional physiotherapy; Other: Rehabilitation program with the use of gait training with the use of a RoboGait stationary robot and conventional physiotherapy.; Other: Rehabilitation program with the use of gait training with the use of the ZEBRIS treadmill and conventional physiotherapy; Other: Rehabilitation program with the use of upper limb function training with the use of the PABLO device and conventional physiotherapy

Interventions

Rehabilitation program with the use of mechanical vibration using the Vibramoov device and conventional physiotherapy OTHER

The Vibramoov device (Techno Concept, France) will be used in the rehabilitation program. Before starting the training session, each subject will undergo a diagnosis in order to qualify for the use of Functional Proprioceptive Vibration. Before starting the therapy, pads are placed on the patient's body to fix the vibrating modules in the places to be treated (lower limbs, left upper limb or right upper limb). Then the vibrating modules are attached to the supports. The therapy carried out with the use of the Vibramoov device consists in the targeted and individualized stimulation of the nervous system, as in the course of natural movements of the upper or lower limbs with the use of visual biofeedback. Therapy with the use of the Vibramoov device will be carried out 4 times a week for 50 minutes a day. Additionally, individual physiotherapy (50 minutes) and upright standing (50 minutes) will be conducted 5 times a week.

Control Group

Rehabilitation program with gait training using the Ekso GT exoskeleton and conventional physiotherapy OTHER

The Ekso GT ™ exoskeleton (Ekso Bionics, Inc. Richmond, CA, USA) used in the rehabilitation program has been approved by the Food and Drug Administration (FDA). Before starting the training session, each subject will undergo a thorough diagnosis to individually adjust the bionic skeleton. After entering the patient's data into the device's software, the physiotherapist selects the optimal training parameters. As the patient progresses during the training unit, the therapist will update the exoskeleton settings on an ongoing basis, so that the training is best suited to the current capabilities of the subject. Therapy with the use of the exoskeleton device will be carried out 4 times a week for 50 minutes a day. Additionally, individual physiotherapy (50 minutes) and upright standing (50 minutes) will be conducted 5 times a week.

Control Group

Rehabilitation program with the use of gait training with the use of a RoboGait stationary robot and conventional physiotherapy. OTHER

The RoboGait stationary robot (Bama technologist, Turkey) will be used in the rehabilitation program. Before starting the training session, each subject will undergo detailed diagnostics in order to individually adjust the orthoses. The next step will be to put on a vest and inguinal straps on a wheelchair or standing, and then lift it up with the device, then attach it to the Robogait orthoses. After entering the patient's data into the software of the device, the physiotherapist selects the optimal training parameters. During the session, biofeedback is also displayed informing the patient and the therapist about the patient's activity level in the transfer phase and the support during walking for both lower limbs. Therapy with the use of the RoboGait device will be carried out 4 times a week for 50 minutes a day. Additionally, individual physiotherapy (50 minutes) and upright standing (50 minutes) will be conducted 5 times a week.

Control Group

Rehabilitation program with the use of gait training with the use of the ZEBRIS treadmill and conventional physiotherapy OTHER

The Zebris FDM-T treadmill will be used in the rehabilitation program for gait analysis. Before each session, patients will be equipped with a harness for safety reasons. The need for a handrail will be assessed prior to each session and patients will be encouraged to support their hands as little as possible. Before starting the training session, each subject will undergo a thorough diagnosis in order to individually adjust the training parameters. Therapy with the use of the Zebris FDM-T treadmill will be carried out 4 times a week for 50 minutes a day. Additionally, individual physiotherapy (50 minutes) and upright standing (50 minutes) will be conducted 5 times a week.

Control Group

Rehabilitation program with the use of upper limb function training with the use of the PABLO device and conventional physiotherapy OTHER

The Pablo (Tyromotion) device will be used in the rehabilitation program. Before the start of the training session, each subject will undergo detailed diagnostics assessing the range of mobility in the shoulder, radiocarpal (frontal and sagittal plane), elbow (sagittal plane), and explosive strength of the cylindrical, pinch and lateral and three-point grip. The Force Control Index will also be designated. The next stage will be training on the Pablo device using visual and auditory biofeedback. The physiotherapist selects the optimal training parameters (type of pad, type of game, level of the game). Each training session will be stored in the software and recorded in the patient's medical records. Therapy with the use of the Pablo device will be carried out 4 times a week for 50 minutes a day. Additionally, individual physiotherapy (50 minutes) and upright standing (50 minutes) will be conducted 5 times a week.

Control Group

Control Group OTHER

In control Group the rehabilitation program will be carried out for a period of 4 weeks. In each of the studied groups, the rehabilitation program will include conventional physiotherapy sessions performed 5 times a week, consisting of 50 minutes a day of individual physiotherapy and 50 minutes a day of standing upright.

Ekso GT exoskeleton Device; PABLO Device; RoboGait Device; Vibramoov Device; ZEBRIS Device

Eligibility Criteria

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

You may qualify if:

• People aged 18 to 75;
• Body height \<190 cm;
• Body weight \<100 kg;
• Normal cognitive status - AMTS\> 6;
• Doctor's consent to participate in the rehabilitation process;
• Informed consent of the examined person to participate in the study;
• Coexistence of a neurological disorder: post-stroke condition; craniocerebral trauma; multiple sclerosis; cerebral palsy; total or partial spinal cord injury; other neurological conditions characterized by a gait problem or an inability to walk and impaired function of the upper limb.

You may not qualify if:

• Severe coexisting diseases (infections, cardiovascular diseases, heart and lung diseases);
• Fracture of the lower limbs in the last 2 years;
• Osteoporosis or densitometry t-score less than -2.5 SD;
• Neurogenic periarticular ossification of the lower limbs;
• Pressure ulcers or wounds in the lower limbs;
• Spasticity\> 4 on the Ashwort scale;
• Pregnancy;
• Colostomy;
• Lower limb prostheses or arthroplasty;
• Significant limitations in the range of motion and pain (hip, knee and ankle joints) that make it difficult to move

Sponsors & Collaborators

• University of Rzeszow: lead
• Donum Corde Rehabilitation Center: collaborator

MeSH Terms

Conditions

Nervous System Diseases; Motor Activity

Interventions

Rehabilitation; Control Groups

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Agnieszka Wiśniowska-Szurlej

  University of Rzeszow

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agnieszka Wiśniowska-Szurlej, PhD

CONTACT

+48 604181162; agwisniowska@ur.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Random selection to two groups (study group and control group)

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 22, 2022
• Study Start: November 1, 2022
• Primary Completion: October 1, 2025
• Study Completion: December 31, 2025
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share