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Completed

NCT Number: NCT07141784

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

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.

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Key information

Conditions

Spinal Cord Injuries (SCI) Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara City Hospital

Çankaya, Ankara, 066800, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

C-Mill® Treadmill Training Combined with Conventional Physiotherapy

Device

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.

Primary outcomes

  1. Berg Balance Scale

    Time frame: 24 months

    Berg Balance Scale for balance assessment

Secondary outcomes

  1. ASIA Lower Extremity Muscle Score

    Time frame: 24 months

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

  2. Timed Up and Go Test

    Time frame: 24 months

    Timed Up and Go Test overground walking assessment

  3. Walking Index in Spinal Cord Injury II

    Time frame: 24 months

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

  4. Ten-Meter Walking Test

    Time frame: 24 months

    Ten-Meter Walking Test for overground walking speed assessment

  5. Gait Speed with Treadmill-Based Gait Analysis

    Time frame: 24 months

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

  6. Cadence Measurement with Treadmill-Based Gait Analysis

    Time frame: 24 months

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

  7. Stride Length Measurement with Treadmill-Based Gait Analysis

    Time frame: 24 months

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

  8. Step Width Measurement with Treadmill-Based Gait Analysis

    Time frame: 24 months

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

  9. Stance Time Difference with Treadmill-Based Gait Analysis

    Time frame: 24 months

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

  10. Spinal Cord Independence Measure (SCIM III)

    Time frame: 24 months

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

  11. World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF)

    Time frame: 24 months

    World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF) for quality of life assessment

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Combined Virtual Reality-Integrated C-Mill® and Conventional Therapy Improves Walking, Mobility, and Quality of Life After Motor-Incomplete Spinal Cord Injury

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 26, 2025
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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