Evaluation of the effectiveness of Methocarbamol in the treatment ofspasticity in people with spinal cord injury.

Phase 1

Conditions: Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2022-000788-30-PL

Lead Sponsor: zdrowisko Kamien Pomorski S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

• a history of spinal cord injury;
• the presence of increased muscle tension on the Ashwort scale 2 to 4;
• time since injury: 3 months;
• the patient must be circulatory and respiratory efficient, alert and aware; adapted to a vertical position;
• a patient with complete and incomplete spinal cord injury, in the cervical, thoracic and lumbar spine, in whom the flexion and extension function will be maintained in the elbow and wrist joints;
• preserved spine stabilization, stabilization of the anastomosis after surgery, completed bone union;
• no contraindications to rehabilitation, such as thrombophlebitis, pulmonary embolism, orthostatic drops in blood pressure, epilepsy, infection.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

• the patient's use of a myorelaxant other than methocarbamol;
• the patient's use of botulinum toxin;
• tetraplegia;
• joint contractures preventing rehabilitation with robots and other contraindications to robotic therapy, such as severe osteoporosis, circulatory and respiratory system disorders, skin lesions, thrombophlebitis, pulmonary embolism, orthostatic drops in blood pressure, epilepsy, infection;
• the presence of open, oozing bedsores;
• malnutrition, wasting of the body (muscle atrophy of the paralyzed without signs of malnutrition and wasting of the body are not the cause of exclusion);
• lack of the patient's informed consent;
• pregnancy or breast-feeding.