NCT06872931

Investigation of the Effects of C-Mill (Hocoma AG, Switzerland) Treadmill Training on Trunk Balance in Patients with Spinal Cord Injury

Active, enrolled Last updated 12 March 2025

What this trial tests

trial in Spinal Cord Injuries (SCI) in 22 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

10 February 2025

Primary endpoint
21 September 2025

21 September 2025

Quick facts

Lead sponsor	Ankara City Hospital Bilkent
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	22
Start date	10 February 2025
Primary completion	21 September 2025
Estimated completion	21 September 2025
Sites	1 location across Turkey (Türkiye)

Conditions studied

• Spinal Cord Injuries (SCI) — all drugs for Spinal Cord Injuries (SCI) →

Sponsor

Ankara City Hospital Bilkent

Who can join

Adults 18 to 65, any sex, with Spinal Cord Injuries (SCI). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study examines how C-Mill treadmill training affects balance and stability in people with spinal cord injury (SCI). Many individuals with SCI experience difficulty with sitting and walking balance, which affects their daily activities and independence. This research aims to explore whether C-Mill, a treadmill that combines virtual reality and sensor-based walking support, can improve trunk stability and mobility.

Who Can Join the Study?

People who:

Are between 18-65 years old Have a spinal cord injury at T4 or lower Are classified as ASIA C or D (moderate to mild impairment) Have stable spinal alignment and can safely participate in walking exercises People who have osteoporosis, heart or lung conditions, additional neurological diseases, or severe joint problems cannot participate.

Our study is a prospective observational study. Regardless of whether exercises are performed conventionally or on an alternative gait platform such as the C-Mill, all interventions are part of routine clinical practice. Patients whose treatment programs already align with the aforementioned procedures will be included. In robotic rehabilitation and assisted gait device laboratories equipped with the C-Mill platform, spinal cord injury patients follow a standardized rehabilitation protocol. These laboratories operate on an appointment-based system. After random group allocation, patients in the study group will undergo assessments at the beginning and end of C-Mill therapy, while control group patients will be enrolled before initiating C-Mill treatment. Following data collection for the control group, these patients will also receive C-Mill therapy.

What Will Happen in the Study?

Participants will be randomly assigned to one of two groups:

C-Mill Group: Receives standard rehabilitation plus C-Mill treadmill training for balance and walking exercises (10 sessions over 4 weeks).

Conventional Therapy Group: Receives standard rehabilitation plus traditional balance and walking exercises (10 sessions over 4 weeks).

How Will the Results Be Measured?

Researchers will assess:

Balance and Stability using functional reach and trunk control tests Independence in Daily Life using a spinal cord-specific scale (SCIM-III) Quality of Life using a health questionnaire (SF-36) Fear of Falling using a visual scale Why Is This Study Important? The study aims to determine if C-Mill training is more effective than traditional rehabilitation in improving balance, stability, and confidence in movement for people with SCI.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.