Spinal Cord InjuryNCT07849062
Robot-Assisted Intensive Physiotherapy in Individuals With Spinal Cord Injury
A study testing Robot-Assisted Physiotherapy and Conventional Physiotherapy in people with Spinal Cord Injury, run by Nuh Naci Yazgan University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Robot-Assisted Physiotherapy and Conventional Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2026to Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kozakli Physical Therapy and Rehabilitation Hospital
Nevşehir
İsa Metin, 00905386220038, pt.is.met@gmail.com
About this study
Official title: Effects of Robot-Assisted Intensive Physiotherapy on Trunk Control, Posture, and Activities of Daily Living in Individuals With Spinal Cord Injury
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.
Read the detailed 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.
- Conditions
- Spinal Cord Injury
- Being tested
- Robot-Assisted Physiotherapy, Conventional Physiotherapy
- Keywords
- robot-assisted physiotherapy, robotic gait training, trunk control, postural control, activities of daily living
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-Assisted PhysiotherapyOther
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 PhysiotherapyOther
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 group | Role | What they receive |
|---|---|---|
| Robot-Assisted Physiotherapy Group | Experimental | 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. Receives: Other: Robot-Assisted Physiotherapy; Other: Conventional Physiotherapy |
| Conventional Physiotherapy Group | Active comparator | Participants will receive individualized conventional physiotherapy focusing on trunk control and balance for 45 minutes per session, 7 days per week, for 8 weeks. Receives: Other: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, week 4, and week 8
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, week 4, and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start1 Oct 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nuh Naci Yazgan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Busra Kepenek Varol, Nuh Naci Yazgan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849062
- Sponsor's protocol ID
- NNYU-2026-01
- Other IDs
- 2025-SA.TEZP-11
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No