Ireland
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Recruiting Not applicable

Robot-Assisted Intensive Physiotherapy in Individuals With Spinal Cord Injury

NCT07849062 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-10-01
Last updated
2026-10-02

Condition(s) studied

Spinal Cord Injury

Investigational drug(s) / intervention(s)

Robot-Assisted PhysiotherapyConventional Physiotherapy

Robot-Assisted Physiotherapy: 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: 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Clinical Trunk Control Test — Baseline, week 4, and week 8
    Trunk control will be assessed using the Clinical Trunk Control Test, which evaluates static trunk control, dynamic trunk control, and dynamic trunk control during upper-extremity activities. The total score ranges from 0 to 24, with higher scores indicating better trunk control.

Trial sites (1)

FacilityCityRegionStatus
Kozakli Physical Therapy and Rehabilitation Hospital Nevşehir Turkey (Türkiye) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07849062 on ClinicalTrials.gov ↗ ← All trials in Turkey