CClinicalTrials.gg
CompletedNCT07141784Updated Aug 26, 2025

VR-Integrated C-Mill® Combined With Conventional Therapy in Motor-Incomplete SCI

An interventional study of C-Mill® Treadmill Training Combined with Conventional Physiotherapy in Spinal Cord Injuries (SCI), sponsored by Ankara City Hospital Bilkent. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-26.

Sponsored by Ankara City Hospital Bilkent · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 6 months after the study started (first participant enrolled Feb 2023, registered Aug 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
11
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

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.

02

Conditions studied

  • Spinal Cord Injuries (SCI)

Keywords

  • Spinal Cord Injury
  • Gait
  • C-Mill
  • Virtual Reality
  • Rehabilitation
03

In context

Spinal Cord Injuries

1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.

This study's enrollment of 11 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

Ankara City Hospital Bilkent is the lead sponsor of 424 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age 18 years or older
  • Diagnosis of spinal cord injury at T4 level or lower
  • American Spinal Injury Association (ASIA) Impairment Scale classification of grade C or D
  • ICD-10 codes S24.73 to S24.77 or S34.70

Exclusion criteria

Exclusion Criteria:

  • History of osteoporosis
  • Cardiopulmonary disease
  • Other neurological disorders
  • Joint-related conditions
  • Concurrent participation in another study
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    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.

    Device: C-Mill® Treadmill Training Combined with Conventional Physiotherapy

Interventions

  • DeviceC-Mill® Treadmill Training Combined with Conventional Physiotherapy

    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.

06

What researchers measure

Primary outcomes

  1. Berg Balance Scale

    Berg Balance Scale for balance assessment

    Time frame: 24 months

Secondary outcomes

  1. ASIA Lower Extremity Muscle Score

    Assessment of lower extremity muscle strength using the American Spinal Injury Association (ASIA) Lower Extremity Motor Score (LEMS)

    Time frame: 24 months

  2. Timed Up and Go Test

    Timed Up and Go Test overground walking assessment

    Time frame: 24 months

  3. Walking Index in Spinal Cord Injury II

    Walking Index in Spinal Cord Injury II for walking independence level assessment

    Time frame: 24 months

  4. Ten-Meter Walking Test

    Ten-Meter Walking Test for overground walking speed assessment

    Time frame: 24 months

  5. Gait Speed with Treadmill-Based Gait Analysis

    Uses treadmill equipment to assess walking speed (kilometers per hour \[km/h\]) during gait analysis.

    Time frame: 24 months

  6. Cadence Measurement with Treadmill-Based Gait Analysis

    Uses treadmill equipment to assess cadence (number of steps per minute)

    Time frame: 24 months

  7. Stride Length Measurement with Treadmill-Based Gait Analysis

    Uses treadmill equipment to assess the length of a single stride during walking.

    Time frame: 24 months

  8. Step Width Measurement with Treadmill-Based Gait Analysis

    Uses treadmill equipment to assess the distance between the heels of the feet during walking

    Time frame: 24 months

  9. Stance Time Difference with Treadmill-Based Gait Analysis

    Uses treadmill equipment to assess stance time difference between lower limbs (seconds \[s\]) during gait analysis.

    Time frame: 24 months

  10. Spinal Cord Independence Measure (SCIM III)

    Spinal Cord Independence Measure (SCIM III) for activity of daily living assessment

    Time frame: 24 months

  11. 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

    Time frame: 24 months

07

Study locations

1 site
  • Ankara City Hospital
    Çankaya, Ankara 066800, Turkey (Türkiye)
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07141784
Lead sponsor
Ankara City Hospital Bilkent
Responsible party
Sponsor
First posted
Aug 26, 2025
Start date
Feb 1, 2023
Primary completion
Feb 1, 2025
Completion
Feb 1, 2025
Last update
Aug 26, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion