The Use of Modern Technologies in Neurorehabilitation

University of Rzeszow

Status: Not yet enrolling

Conditions: Physical Activity; Biomedical Enhancement; Nervous System Diseases; Neurorehabilitation

Treatments: Other: Rehabilitation program with the use of mechanical vibration using the Vibramoov device and conventional physiotherapy; Other: Control Group; Other: Rehabilitation program with the use of upper limb function training with the use of the PABLO device 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 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.

Study type: Interventional

Funder types: Other

Identifiers

NCT05550987

Neurorehabilitation

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 6 patient groups

Vibramoov Device

Experimental group

Description:

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

Treatment:

Other: Control Group

Ekso GT exoskeleton Device

Experimental group

Description:

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

Treatment:

Other: Control Group

RoboGait Device

Experimental group

Description:

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

Treatment:

Other: Control Group

ZEBRIS Device

Experimental group

Description:

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

Treatment:

Other: Control Group

PABLO Device

Experimental group

Description:

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

Treatment:

Other: Control Group

Control Group

Experimental group

Description:

Rehabilitation program with conventional physiotherapy

Treatment:

Other: Rehabilitation program with the use of upper limb function training with the use of the PABLO device 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 gait training with the use of a RoboGait stationary robot and 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