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

NCT07141784 | Completed

• 1 other identifier: AnkaraCHBilkent-PMR-MSS-04
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injuries (SCI)

Keywords

Spinal Cord Injury; Gait; C-Mill; Virtual Reality; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Berg Balance Scale

  Berg Balance Scale for balance assessment

  24 months

Secondary Outcomes (11)

• ASIA Lower Extremity Muscle Score

  24 months

• Timed Up and Go Test

  24 months

• Walking Index in Spinal Cord Injury II

  24 months

• Ten-Meter Walking Test

  24 months

• Gait Speed with Treadmill-Based Gait Analysis

  24 months

Study Arms (1)

C-Mill® Treadmill Training Plus Conventional Physiotherapy

EXPERIMENTAL

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

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.

C-Mill® Treadmill Training Plus Conventional Physiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Çankaya, Ankara, 066800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: August 26, 2025
• Study Start: February 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-08

Locations

TU (1)