The Use of Modern Technologies in Neurorehabilitation

NCT ID: NCT05550987

Last Updated: 2022-11-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2025-12-31

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.

Detailed Description

Study participants will be recruited from the Donum Corde Rehabilitation Center. After meeting the inclusion criteria, the qualification for the use of modern technologies in the rehabilitation process will be performed. After a patient is enrolled in one of the five study programs, study participants will be randomly assigned to the study group and the control group. Randomization will be performed by a statistician, a member of the research team. After randomization, the rehabilitation program will be carried out for a period of 4 weeks. In each of the studied groups, the rehabilitation program will include therapy with the use of modern technologies, performed 4 times a week, 50 minutes a day, and 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. Exercises will be performed by qualified physiotherapists with at least 3 years of experience in working with neurological patients. Therapies with the use of modern technologies will be performed by certified physiotherapists after training and courses in the use of modern rehabilitation devices. The improvement process will take place from Monday to Friday for 4 weeks, under the supervision of the Scientific and Medical Research Supervisor and the care and consent of the ward doctor. After 4 weeks of exercise, examination II will be performed after rehabilitation is complete. The obtained results will be statistically analyzed.

Conditions

Neurorehabilitation; Nervous System Diseases; Biomedical Enhancement; Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vibramoov Device

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

Group Type: EXPERIMENTAL

Control Group

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Control Group

Intervention Type: 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.

RoboGait Device

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

Group Type: EXPERIMENTAL

Control Group

Intervention Type: 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.

ZEBRIS Device

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

Group Type: EXPERIMENTAL

Control Group

Intervention Type: 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.

PABLO Device

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

Group Type: EXPERIMENTAL

Control Group

Intervention Type: 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.

Control Group

Rehabilitation program with conventional physiotherapy

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

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

Intervention Type: 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.

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

Intervention Type: 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.

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

Intervention Type: 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.

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: OTHER

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

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.

Intervention Type: OTHER

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

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.

Intervention Type: OTHER

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

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.

Intervention Type: OTHER

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

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.

Intervention Type: OTHER

Control Group

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Donum Corde Rehabilitation Center

UNKNOWN

Sponsor Role: collaborator

University of Rzeszow

OTHER

Sponsor Role: lead

Responsible Party

Agnieszka Wiśniowska-Szurlej

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Agnieszka Wiśniowska-Szurlej

Role: PRINCIPAL_INVESTIGATOR

University of Rzeszow

Central Contacts

Agnieszka Wiśniowska-Szurlej, PhD

Role: CONTACT

agwisniowska@ur.edu.pl

+48 604181162

Other Identifiers

Neurorehabilitation

Identifier Type: -

Identifier Source: org_study_id