Clinical trial NCT05550987: The Use of Modern Technologies in Neurorehabilitation
Official title: Assessment of the Effectiveness of the Use of Modern Technologies in the Rehabilitation of Patients With Neurological Diseases
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Neurorehabilitation
Nervous System Diseases
Biomedical Enhancement
Physical Activity
Keywords: Exercise Therapy
Neurological Rehabilitation,
Recovery of Function
Lead sponsor: University of Rzeszow
Sponsor class: OTHER
Collaborators: name: Donum Corde Rehabilitation Center
First posted: 2022-09-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Random selection to two groups (study group and control group)
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: An assessment of static and dynamic balance using Berg Balance Scale (BBS)
timeFrame: at baseline, immediately after treatment
measure: An assessment of locomotor stages after Spinal Cord Injury using LOSSCI Scale
timeFrame: at baseline, immediately after treatment completion
measure: An assessment of trunk movement using The Trunk Control Test for Motor Impairment After Stroke (TCT)
timeFrame: at baseline, immediately after treatment completion
measure: An assessment of fall risk using Timed Up and Go Test (TUG)
timeFrame: at baseline, immediately after treatment completion
measure: An assessment of motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale
timeFrame: at baseline, immediately after treatment completion
Secondary outcomes:
measure: An assessment of muscle tone using modified Tardieu Scale
timeFrame: at baseline, immediately after treatment completion
measure: 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
timeFrame: at baseline, immediately after treatment completion
measure: An assessment of strength and quality of grips carried out on the Pablo
timeFrame: at baseline, immediately after treatment completion
measure: Analysis of gait spatiotemporal parameters carried out on Zebris
timeFrame: at baseline, immediately after treatment completion
measure: Analysis of isometric muscle strength carried out on RoboGait
timeFrame: at baseline, immediately after treatment completion
measure: Analysis of gait carried out on Ekso Skeleton
timeFrame: at baseline, immediately after treatment completion
measure: An assessment of manual skills using Box and Blocks Test
timeFrame: at baseline, immediately after treatment completion
measure: An assessment of handgrip function using Franchay scale
timeFrame: at baseline, immediately after treatment completion
measure: An assessment of ability to perform basic activities of daily living using Barthel Index
timeFrame: at baseline, immediately after treatment completion
measure: An assessment of body composition using subjected to bioelectrical impedancy analysis - Tanita 780
timeFrame: at baseline, immediately after treatment completion
measure: An assessment of quality of life using The World Health Organization quality of life (WHOQOL) - BREF
timeFrame: at baseline, immediately after treatment completion
measure: An assessment of level of disability using The World Health Organization Disability Assessment Schedule (WHODAS 2.0)
timeFrame: at baseline, immediately after treatment completion
measure: An assessment of Lung Capacity assessment using a peak expiratory flow (PEV) measurement
timeFrame: at baseline, immediately after treatment completion
measure: An assessment of walking speed using the 10 meter walk test (10MTW)
timeFrame: at baseline, immediately after treatment completion
Other outcomes:
measure: An assessment of cognitive state using The abbreviated mental test score (AMTS)
timeFrame: at baseline, immediately after treatment completion
measure: An assessment of anxiety and depression using Hospital Anxiety and Depression Scale (HADS)
timeFrame: at baseline, immediately after treatment completion
Locations:
Study officials:
affiliation: University of Rzeszow
name: Agnieszka Wiśniowska-Szurlej
role: PRINCIPAL_INVESTIGATOR
References: