Spinal Cord Injuries (SCI)NCT07141784
VR-Integrated C-Mill® Combined With Conventional Therapy in Motor-Incomplete SCI
An observational study of Spinal Cord Injuries (SCI), run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
This study investigates the effects of C-Mill® treadmill training, which integrates virtual reality and gamified tasks, combined with conventional physiotherapy, on walking ability, mobility, functional independence, and health-related quality of life in individuals with motor-incomplete spinal cord injury (iSCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries (SCI)
- What is being tested?
- C-Mill® Treadmill Training Combined with Conventional Physiotherapy
- Type of treatment
- Medical device
- How many people
- 11 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2023to 1 Feb 2025
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 18 years or older with motor-incomplete spinal cord injury at the T4 level or below (AIS C or D) who received routine clinical rehabilitation at a specialized spinal cord injury center. Eligible participants received a routine rehabilitation program integrating C-Mill® VR Plus treadmill training with conventional therapy and were evaluated before and after the 4-week rehabilitation period. Treatment allocation was based on routine clinical practice and was not determined by the research protocol.
Who may be able to join
- Age 18 years or older Diagnosis of spinal cord injury at the T4 level or below American Spinal Injury Association (ASIA) Impairment Scale classification of grade C or D ICD-10 codes S24.73 to S24.77 or S34.70 to S34.77
Who cannot join
- History of osteoporosis Cardiopulmonary disease Other neurological disorders Joint-related conditions Concurrent participation in another study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Virtual Reality-Integrated C-Mill® and Conventional Therapy Improves Walking, Mobility, and Quality of Life After Motor-Incomplete Spinal Cord Injury
This study investigates the effects of C-Mill® treadmill training, which integrates virtual reality and gamified tasks, combined with conventional physiotherapy, on walking ability, mobility, functional independence, and health-related quality of life in individuals with motor-incomplete spinal cord injury (iSCI).
Participants are adults aged 18 years or older with injury at the T4 level or below, classified as American Spinal Injury Association (ASIA) Impairment Scale grade C or D, and with ICD-10 codes S24.73-S24.77 or S34.70. Individuals with a history of osteoporosis, cardiopulmonary disease, other neurological disorders, joint-related conditions, or concurrent participation in another study are excluded.
All participants complete a 4-week integrated rehabilitation program at a specialized spinal cord injury center. The program consists of 10 C-Mill® sessions in addition to conventional physiotherapy, targeting balance, gait, and walking speed through task-specific training and individualized exercises to improve mobility, strength, and functional skills.
Read the detailed description
Spinal cord injury (SCI) limits mobility and independence, creating substantial physical and psychological burdens. Virtual reality and gamified treadmill systems such as the C-Mill® may enhance walking rehabilitation through task-specific and engaging practice.
This observational study investigated the effects of C-Mill® treadmill training combined with conventional physiotherapy on walking ability, mobility, functional independence, and health-related quality of life in individuals with motor-incomplete SCI (iSCI). The C-Mill® system provides task-specific, engaging, and safe walking practice through real-time visual feedback and interactive scenarios designed to improve balance, gait speed, and obstacle negotiation.
Participants were adults aged 18 years or older, with spinal cord injury at the T4 level or below, classified as American Spinal Injury Association (ASIA) Impairment Scale grade C or D. ICD-10 codes for inclusion ranged from S24.73 to S24.77 or S34.70. Individuals were in the chronic phase of iSCI and were excluded if they had a history of osteoporosis, cardiopulmonary disease, other neurological disorders, joint-related conditions, or concurrent participation in another study.
All participants completed a 4-week integrated rehabilitation program at a specialized spinal cord injury center. The program consisted of 10 C-Mill® training sessions in addition to conventional physiotherapy. Each C-Mill® session included activities targeting static and dynamic balance, stride regulation, and safe gait adaptation, with progressive difficulty tailored to each participant's abilities. Conventional therapy included individualized physiotherapy exercises focusing on mobility, strength, and functional skills to support walking performance and independence.
- Conditions
- Spinal Cord Injuries (SCI)
- Being tested
- C-Mill® Treadmill Training Combined with Conventional Physiotherapy
- Keywords
- Spinal Cord Injury, Gait, C-Mill, Virtual Reality, Rehabilitation
- 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.
C-Mill® Treadmill Training Combined with Conventional PhysiotherapyDevice
Participants received a 4-week integrated rehabilitation program consisting of 10 C-Mill® treadmill training sessions in addition to individualized conventional physiotherapy. C-Mill® sessions incorporated virtual reality and gamified tasks to improve static and dynamic balance, gait speed, stride regulation, and safe obstacle negotiation. Conventional physiotherapy targeted mobility, muscle strength, and functional skills to enhance walking performance and independence.
| Study group | Role | What they receive |
|---|---|---|
| C-Mill® Treadmill Training Plus Conventional Physiotherapy | Participants received an integrated rehabilitation program consisting of C-Mill® treadmill training combined with conventional physiotherapy. The program lasted 4 weeks and included 10 C-Mill® sessions in addition to individualized physiotherapy exercises. Each C-Mill® session incorporated virtual reality and gamified tasks to improve static and dynamic balance and to regulate gait. Conventional physiotherapy focused on mobility, muscle strength, and functional skills to enhance walking performance and independence. Receives: Device: C-Mill® Treadmill Training Combined with Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
Berg Balance Scale for balance assessment
Measured: 24 months
Secondary outcomes (11)
ASIA Lower Extremity Muscle Score
Assessment of lower extremity muscle strength using the American Spinal Injury Association (ASIA) Lower Extremity Motor Score (LEMS)
Measured: 24 months
Timed Up and Go Test
Timed Up and Go Test overground walking assessment
Measured: 24 months
Walking Index in Spinal Cord Injury II
Walking Index in Spinal Cord Injury II for walking independence level assessment
Measured: 24 months
Ten-Meter Walking Test
Ten-Meter Walking Test for overground walking speed assessment
Measured: 24 months
Gait Speed with Treadmill-Based Gait Analysis
Uses treadmill equipment to assess walking speed (kilometers per hour [km/h]) during gait analysis.
Measured: 24 months
Cadence Measurement with Treadmill-Based Gait Analysis
Uses treadmill equipment to assess cadence (number of steps per minute)
Measured: 24 months
Stride Length Measurement with Treadmill-Based Gait Analysis
Uses treadmill equipment to assess the length of a single stride during walking.
Measured: 24 months
Step Width Measurement with Treadmill-Based Gait Analysis
Uses treadmill equipment to assess the distance between the heels of the feet during walking
Measured: 24 months
Stance Time Difference with Treadmill-Based Gait Analysis
Uses treadmill equipment to assess stance time difference between lower limbs (seconds [s]) during gait analysis.
Measured: 24 months
Spinal Cord Independence Measure (SCIM III)
Spinal Cord Independence Measure (SCIM III) for activity of daily living assessment
Measured: 24 months
World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF)
World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF) for quality of life assessment
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start1 Feb 2023
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injuries (SCI)Studies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141784
- Sponsor's protocol ID
- AnkaraCHBilkent-PMR-MSS-04
- Status last verified
- Aug 2025
- First submitted
- 15 Aug 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Virtual Reality-Integrated C-Mill® and Conventional Therapy Improves Walking, Mobility, and Quality of Life After Motor-Incomplete Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07141784
- Acronym / sponsor ID
- AnkaraCHBilkent-PMR-MSS-04
- Conditions
- Spinal Cord Injuries (SCI)
- Keywords
- Spinal Cord Injury, Gait, C-Mill, Virtual Reality, Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the effects of C-Mill® treadmill training, which integrates virtual reality and gamified tasks, combined with conventional physiotherapy, on walking ability, mobility, functional independence, and health-related quality of life in individuals with motor-incomplete spinal cord injury (iSCI).
Participants are adults aged 18 years or older with injury at the T4 level or below, classified as American Spinal Injury Association (ASIA) Impairment Scale grade C or D, and with ICD-10 codes S24.73-S24.77 or S34.70. Individuals with a history of osteoporosis, cardiopulmonary disease, other neurological disorders, joint-related conditions, or concurrent participation in another study are excluded.
All participants complete a 4-week integrated rehabilitation program at a specialized spinal cord injury center. The program consists of 10 C-Mill® sessions in addition to conventional physiotherapy, targeting balance, gait, and walking speed through task-specific training and individualized exercises to improve mobility, strength, and functional skills.
Detailed description
Spinal cord injury (SCI) limits mobility and independence, creating substantial physical and psychological burdens. Virtual reality and gamified treadmill systems such as the C-Mill® may enhance walking rehabilitation through task-specific and engaging practice.
This observational study investigated the effects of C-Mill® treadmill training combined with conventional physiotherapy on walking ability, mobility, functional independence, and health-related quality of life in individuals with motor-incomplete SCI (iSCI). The C-Mill® system provides task-specific, engaging, and safe walking practice through real-time visual feedback and interactive scenarios designed to improve balance, gait speed, and obstacle negotiation.
Participants were adults aged 18 years or older, with spinal cord injury at the T4 level or below, classified as American Spinal Injury Association (ASIA) Impairment Scale grade C or D. ICD-10 codes for inclusion ranged from S24.73 to S24.77 or S34.70. Individuals were in the chronic phase of iSCI and were excluded if they had a history of osteoporosis, cardiopulmonary disease, other neurological disorders, joint-related conditions, or concurrent participation in another study.
All participants completed a 4-week integrated rehabilitation program at a specialized spinal cord injury center. The program consisted of 10 C-Mill® training sessions in addition to conventional physiotherapy. Each C-Mill® session included activities targeting static and dynamic balance, stride regulation, and safe gait adaptation, with progressive difficulty tailored to each participant's abilities. Conventional therapy included individualized physiotherapy exercises focusing on mobility, strength, and functional skills to support walking performance and independence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| C-Mill® Treadmill Training Plus Conventional Physiotherapy | – | Device: C-Mill® Treadmill Training Combined with Conventional PhysiotherapyParticipants received an integrated rehabilitation program consisting of C-Mill® treadmill training combined with conventional physiotherapy. The program lasted 4 weeks and included 10 C-Mill® sessions in addition to individualized physiotherapy exercises. Each C-Mill® session incorporated virtual reality and gamified tasks to improve static and dynamic balance and to regulate gait. Conventional physiotherapy focused on mobility, muscle strength, and functional skills to enhance walking performance and independence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 years or older with motor-incomplete spinal cord injury at the T4 level or below (AIS C or D) who received routine clinical rehabilitation at a specialized spinal cord injury center. Eligible participants received a routine rehabilitation program integrating C-Mill® VR Plus treadmill training with conventional therapy and were evaluated before and after the 4-week rehabilitation period. Treatment allocation was based on routine clinical practice and was not determined by the research protocol.
Key inclusion criteria (1 listed)
- Age 18 years or older Diagnosis of spinal cord injury at the T4 level or below American Spinal Injury Association (ASIA) Impairment Scale classification of grade C or D ICD-10 codes S24.73 to S24.77 or S34.70 to S34.77
Key exclusion criteria (1 listed)
- History of osteoporosis Cardiopulmonary disease Other neurological disorders Joint-related conditions Concurrent participation in another study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-Mill® Treadmill Training Combined with Conventional PhysiotherapyParticipants received a 4-week integrated rehabilitation program consisting of 10 C-Mill® treadmill training sessions in addition to individualized conventional physiotherapy. C-Mill® sessions incorporated virtual reality and gamified tasks to improve static and dynamic balance, gait speed, stride regulation, and safe obstacle negotiation. Conventional physiotherapy targeted mobility, muscle strength, and functional skills to enhance walking performance and independence. | Device | C-Mill® Treadmill Training Plus Conventional Physiotherapy |
Primary outcome
Berg Balance Scale
Time frame: 24 months
Berg Balance Scale for balance assessment
11 secondary outcomes
ASIA Lower Extremity Muscle Score
Time frame: 24 months
Timed Up and Go Test
Time frame: 24 months
Walking Index in Spinal Cord Injury II
Time frame: 24 months
Ten-Meter Walking Test
Time frame: 24 months
Gait Speed with Treadmill-Based Gait Analysis
Time frame: 24 months
Cadence Measurement with Treadmill-Based Gait Analysis
Time frame: 24 months
Stride Length Measurement with Treadmill-Based Gait Analysis
Time frame: 24 months
Step Width Measurement with Treadmill-Based Gait Analysis
Time frame: 24 months
Stance Time Difference with Treadmill-Based Gait Analysis
Time frame: 24 months
Spinal Cord Independence Measure (SCIM III)
Time frame: 24 months
World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF)
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries (SCI), run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.