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Robot-Assisted Intensive Physiotherapy in Individuals With Spinal Cord Injury

Robot-Assisted Intensive Physiotherapy in Individuals With Spinal Cord Injury

Recruiting
18-55 years
All
Phase N/A

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Overview

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.

Description

This study is designed as a randomized controlled trial 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 allocated to either an experimental group or a control group using computer-generated randomization. Both groups will receive treatment for 8 weeks, with 45-minute sessions provided 7 days per week. Participants in the experimental group will receive robot-assisted physiotherapy using the Robogait robotic gait training system 3 days per week and trunk-focused conventional physiotherapy 4 days per week. Participants in the control group will receive trunk-focused conventional physiotherapy 7 days per week. The conventional physiotherapy program will include warm-up and cool-down exercises and an individualized exercise program primarily targeting trunk control and balance. The program may include posterior pelvic tilt exercises, active and active-assisted lower-extremity range-of-motion exercises, lower-extremity exercises against gravity, static and dynamic sitting balance exercises, weight-shifting activities, and balance exercises performed using a balance board and exercise ball, individualized according to each participant's functional status. During robot-assisted physiotherapy sessions, participants will undergo gait training using the Robogait robotic gait training system. Following a 5-minute warm-up, robotic gait training will be performed for approximately 35 minutes, followed by a 5-minute cool-down. Body-weight support, robotic assistance, and gait speed will be individualized according to each participant's clinical and functional status. Assessments will be performed at baseline, at the end of week 4, and at the end of week 8. Evaluations will include trunk control and balance, posture, activities of daily living, muscle strength, and muscle tone.

Eligibility

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

Study details
    Spinal Cord Injury

NCT07849062

Nuh Naci Yazgan University

20 October 2026

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