Robot-Assisted Intensive Physiotherapy in Individuals With Spinal Cord Injury
ConditionSpinal Cord Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorNuh Naci Yazgan University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Robot-Assisted Physiotherapy
Other interventionRobot-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 interventionThe 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.
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: Robot-Assisted Physiotherapy GroupExperimental treatment 2 interventions
Group B: Conventional Physiotherapy GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 8Secondary outcomes
1
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 82
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 83
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 84
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 8Sponsors and contacts
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Source ClinicalTrials.gov