Assessment of the Effectiveness of the Use of Modern Technologies in the Rehabilitation of Patients With Neurological Diseases
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neurorehabilitation
- Sponsor
- University of Rzeszow
- Enrollment
- 120
- Primary Endpoint
- An assessment of trunk movement using The Trunk Control Test for Motor Impairment After Stroke (TCT)
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Agnieszka Wiśniowska-Szurlej
PhD
University of Rzeszow
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
Outcomes
Primary Outcomes
An assessment of trunk movement using The Trunk Control Test for Motor Impairment After Stroke (TCT)
Time Frame: at baseline, immediately after treatment completion
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).
An assessment of static and dynamic balance using Berg Balance Scale (BBS)
Time Frame: at baseline, immediately after treatment
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.
An assessment of motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale
Time Frame: at baseline, immediately after treatment completion
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.
An assessment of locomotor stages after Spinal Cord Injury using LOSSCI Scale
Time Frame: at baseline, immediately after treatment completion
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.
An assessment of fall risk using Timed Up and Go Test (TUG)
Time Frame: at baseline, immediately after treatment completion
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.
Secondary Outcomes
- Analysis of gait carried out on Ekso Skeleton(at baseline, immediately after treatment completion)
- An assessment of handgrip function using Franchay scale(at baseline, immediately after treatment completion)
- An assessment of ability to perform basic activities of daily living using Barthel Index(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)
- 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)
- An assessment of muscle tone using modified Tardieu Scale(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)
- An assessment of manual skills using Box and Blocks Test(at baseline, immediately after treatment completion)
- An assessment of body composition using subjected to bioelectrical impedancy analysis - Tanita 780(at baseline, immediately after treatment completion)
- An assessment of quality of life using The World Health Organization quality of life (WHOQOL) - BREF(at baseline, immediately after treatment completion)
- An assessment of walking speed using the 10 meter walk test (10MTW)(at baseline, immediately after treatment completion)
- An assessment of level of disability using The World Health Organization Disability Assessment Schedule (WHODAS 2.0)(at baseline, immediately after treatment completion)
- An assessment of Lung Capacity assessment using a peak expiratory flow (PEV) measurement(at baseline, immediately after treatment completion)