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NCT07849062
Robot-Assisted Intensive Physiotherapy in Individuals With Spinal Cord Injury
Conditions: Spinal Cord Injury
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: No
Phase: NA
Enrollment: 52
Sponsor: Nuh Naci Yazgan University
Location: Kozakli Physical Therapy and Rehabilitation Hospital Nevşehir
Summary
This randomized controlled trial aims to investigate the effects of robot-assisted intensive physiotherapy on trunk control, posture, and activities of daily living in individuals with spinal cord injury. A total of 52 participants will be randomly assigned to an experimental group or a control group. Both groups will receive 45-minute treatment sessions 7 days per week for 8 weeks. The experimental group will receive robot-assisted physiotherapy 3 days per week and trunk-focused conventional physiotherapy 4 days per week, whereas the control group will receive trunk-focused conventional physiotherapy 7 days per week. Participants will be evaluated at baseline, at the end of week 4, and at the end of week 8.
Eligibility Criteria
Inclusion Criteria:
* Aged 18-55 years
* American Spinal Injury Association (ASIA) Impairment Scale grade C or D
* Incomplete upper motor neuron spinal cord injury
* Neurological level of injury at T10 or above
* Normal range of motion of the hip, knee, and ankle joints
* Receiving inpatient rehabilitation
* At least 6 months since spinal cord injury
Exclusion Criteria:
* Receiving outpatient rehabilitation
* Concurrent participation in another physiotherapy or rehabilitation program
* Spasticity of grade 3 or higher according to the Modified Ashworth Scale in any lower-extremity muscle that limits movement
* Lower motor neuron injury
* Body weight greater than 130 kg
* Open skin ulceration in areas contacting the exoskeleton or harness
* Active heterotopic ossification
* Hip dislocation and/or hip or knee alignment abnormalities
* Diagnosed psychiatric disorder
* Insufficient ability to cooperate with robot-assisted rehabilitation
* Uncontrolled epilepsy
* Osteoporosis
* Unhealed fracture
* Metal implants in the lower extremities
Source: ClinicalTrials.gov (NCT07849062). StuddyBuddy aggregates publicly available trial information.