Clinical trial NCT06872931: Investigation of the Effects of C-Mill (Hocoma AG, Switzerland) Treadmill Training on Trunk Balance in Patients with Spinal Cord Injury
Official title: Investigation of the Effects of C-Mill (Hocoma AG, Switzerland) Treadmill Training on Trunk Balance in Patients with Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Spinal Cord Injuries (SCI)
Keywords: Postural balance
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be treated at Ankara City Hospital, Department of Physical Medicine and Rehabilitation, within the Neurophysiological Exercise and Robotic Rehabilitation Laboratories.

Brief summary: 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.

Detailed description: Enhancing trunk balance and stability is a key objective in SCI rehabilitation. Various exercise modalities, including proprioceptive training, core strengthening, yoga, and Pilates, are employed to improve motor skills, coordination, and quality of life. Recently, virtual reality (VR)-based approaches, such as the C-Mill treadmill (Hocoma AG, Switzerland), have gained prominence. The C-Mill integrates visual and motor training through a suspension-supported system that ensures safe ambulation while adapting to the patient's pace. Unlike conventional treadmills and robotic-assisted devices, it uniquely incorporates VR to simulate real-world gait challenges, bridging the gap between traditional therapies and independent walking.

This study aims to investigate the effects of gait exercises performed with the C-Mill treadmill on trunk balance and stability by leveraging its advantages, such as gradual weight-bearing, improved gait stability, and reduced fatigue.

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. The study aims to identify differences in outcomes between the applied interventions.

Data Quality and Management Procedures Patients admitted for inpatient treatment at the Spinal Cord Injury Rehabilitation Clinic of Ankara Bilkent City Hospital, who meet the inclusion criteria and voluntarily agree to participate in the study by reading and signing the informed consent form, will be included in the study. The medical status of all participants will be evaluated and recorded by the clinical research responsible physician.

A predefined data management plan will be implemented for missing, inconsistent, or erroneous data. Missing data will be identified and analyzed using statistical methods such as multiple imputation when necessary.

To ensure the integrity of data entry, regular audits and consistency checks will be performed by a physiotherapist involved in the study. To increase the reliability of the data, patient records and assessment reports will be cross-checked with the collected data. This will include comparisons made with electronic health records, paper-based case reports, and direct observation notes. All study procedures, including patient recruitment, data collection, data entry, data analysis, and reporting of adverse events, will be carried out according to predefined criteria.

Any adverse events or unexpected complications occurring during the study will be systematically documented and reported.

The determination of the appropriate sample size was based on the study by Khurana et al. A priori power analysis was conducted using the G\* Power software (version 3.0.10, Universität Düsseldorf, Düsseldorf, Germany). The sample size for our study was calculated to include a minimum of 11 patients per group, ensuring 80% power with an alpha error rate of 0.05.

For statistical analysis, descriptive statistics will be presented as the mean and standard deviation for numerical variables if the parametric assumptions are met, and as the median and minimum-maximum values if the parametric assumptions are not met. For categorical variables, frequency and percentage values will be reported. The statistical significance of differences between groups will be examined using the Independent Samples T-Test if parametric assumptions are met, and the Mann-Whitney U Test if parametric assumptions are not met. Analyses will be conducted with a significance level of p \< 0.05.

Eligibility criteria: Inclusion Criteria:

* Age between 18-65 years
* SCI at T4 or below
* ASIA classification C or D
* Spinal stabilization achieved
* Willingness to participate voluntarily

Exclusion Criteria:

* Osteoporosis
* Cardiopulmonary disease
* Neurological conditions other than SCI
* Joint or musculoskeletal disorders
* Presence of orthostatic hypotension

Primary outcomes:
measure: Functional Reach Test
timeFrame: Four weeks
Secondary outcomes:
measure: Berg Balance Scale
timeFrame: Four weeks
measure: 36-Item Short Form Survey (SF-36)
timeFrame: Four weeks
measure: Spinal Cord Independence Measure (SCIM)
timeFrame: Four weeks
measure: Trunk Stability Measurement
timeFrame: Four weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
Study officials:
References: