An interventional study of Robot-Assisted Physiotherapy and Conventional Physiotherapy in Spinal Cord Injury, sponsored by Nuh Naci Yazgan University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Nuh Naci Yazgan University · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Participants will receive an 8-week physiotherapy program, 7 days per week, with each session lasting 45 minutes. The program will consist of robot-assisted physiotherapy using the Robogait robotic gait training system 3 days per week and individualized conventional physiotherapy focusing on trunk control and balance 4 days per week.
Other: Robot-Assisted Physiotherapy · Other: Conventional Physiotherapy
Participants will receive individualized conventional physiotherapy focusing on trunk control and balance for 45 minutes per session, 7 days per week, for 8 weeks.
Other: Conventional 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.
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.
Clinical Trunk Control Test
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.
Time frame: Baseline, week 4, and week 8
Modified Functional Reach Test
Trunk balance will be assessed using the Modified Functional Reach Test in the sitting position. The distance between the initial position of the fingertip and the maximal forward reach without loss of balance will be measured in centimeters. The test will be performed three times, and the mean of the three measurements will be used for analysis. Greater reach distance indicates better dynamic sitting balance.
Time frame: Baseline, week 4, and week 8
Lateral Reach Test
Lateral trunk balance will be assessed in the sitting position using the Lateral Reach Test. The maximal lateral reach distance will be measured in centimeters based on the displacement of the third metacarpophalangeal joint. The test will be performed three times on each side, and the mean distance will be calculated. Greater reach distance indicates better lateral trunk balance.
Time frame: Baseline, week 4, and week 8
Spinal Cord Independence Measure III
Independence in activities of daily living will be assessed using the Spinal Cord Independence Measure III (SCIM-III). The scale consists of 19 items across three domains: self-care, respiration and sphincter management, and mobility. The total score ranges from 0 to 100 points, with higher scores indicating greater functional independence.
Time frame: Baseline, week 4, and week 8
Sitting Posture Assessment
Sitting posture will be assessed using the PostureScreen Mobile application. Standardized photographs will be obtained while participants are in the sitting position and analyzed from posterior and lateral views to quantify postural alignment.
Time frame: Baseline, week 4, and week 8
Manual Muscle Testing
Muscle strength will be assessed using Manual Muscle Testing. Muscle strength will be graded on a 6-point ordinal scale from 0 to 5, where 0 indicates no detectable muscle contraction and 5 indicates normal muscle strength against maximal resistance. Higher scores indicate greater muscle strength.
Time frame: Baseline, week 4, and week 8
Modified Ashworth Scale
Muscle tone and spasticity will be assessed using the Modified Ashworth Scale. The scale grades resistance encountered during passive muscle stretching from 0 to 4, including a 1+ category. A score of 0 indicates no increase in muscle tone, whereas a score of 4 indicates that the affected part is rigid in flexion or extension. Higher scores indicate greater spasticity.
Time frame: Baseline, week 4, and week 8
Plan to share: No
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Nuh Naci Yazgan University