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Robot-Assisted Intensive Physiotherapy in Individuals With Spinal Cord Injury

Sponsor: Nuh Naci Yazgan University • ClinicalTrials.gov ID: NCT07849062

Registry updated: 2026-10-02

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Description

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.

Interventions

Robot-Assisted Physiotherapy (Other)
Robot-assisted gait training will be performed using the Robogait robotic gait training system. Each 45-minute session will include 5 minutes of warm-up, 35 minutes of robotic gait training, and 5 minutes of cool-down exercises. Body-weight support, robotic assistance, and walking speed will be individualized according to each participant's clinical condition. Initial settings will consist of 50% body-weight support, 60% robotic assistance, and a walking speed of 1.5 km/h, with adjustments made as needed during treatment. Participants in the experimental group will receive robot-assisted physiotherapy 3 days per week for 8 weeks.
Conventional Physiotherapy (Other)
The conventional physiotherapy program will consist of individualized exercises aimed at improving trunk control, balance, mobility, and lower-extremity function. Each 45-minute session will include warm-up and cool-down exercises, range-of-motion and flexibility exercises, posterior pelvic tilt exercises, active and active-assisted lower-extremity exercises, gravity-resisted lower-extremity exercises, static and dynamic sitting balance exercises, weight-shifting exercises, and balance exercises using a balance board and exercise ball. Participants in the experimental group will receive conventional physiotherapy 4 days per week, whereas participants in the control group will receive conventional physiotherapy 7 days per week. Treatment will continue for 8 weeks.

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

Conditions

Spinal Cord Injury

Locations

Kozakli Physical Therapy and Rehabilitation Hospital — Nevşehir, Turkey (Türkiye)

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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