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

NCT ID: NCT06872931

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 22 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-10
• Study Completion Date: 2025-09-21

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.

Conditions

Spinal Cord Injuries (SCI)

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

conventional balance exercises

In addition to conventional therapy, conventional balance exercises group will undergo conventional balance exercises and gait training, either within or outside the parallel bars, for a minimum of two days per week in 30-minute sessions. Over four weeks, they will complete a total of 10 sessions of gait and balance training.

No interventions assigned to this group

Treadmill training group

In addition to conventional therapy, the Treadmill training group will undergo static and dynamic balance exercises and gait training on the C-Mill platform for a minimum of two days per week, with sessions lasting 30 minutes each. Over four weeks, they will complete a total of 10 sessions of gait and balance training on the C-Mill platform.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Sinem Yıldırım

MSc Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ankara Bilkent City Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

TABED 1-24-346

Identifier Type: -

Identifier Source: org_study_id