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

NCT06872931 | Active Not Recruiting

• 1 other identifier: TABED 1-24-346
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries (SCI)

Keywords

Postural balance

Outcome Measures

Primary Outcomes (1)

• Functional Reach Test

  The patient is instructed to stand next to, but not touching, a wall and position the arm that is closer to the wall at 90 degrees of shoulder flexion with a closed fist. The assessor records the starting position at the 3rd metacarpal head on the yardstick. Patient is instructed to reach as farther as possible without moving from the ground The location of the 3rd metacarpal is recorded again. Scores are determined by assessing the difference between the start and end position is the reach distance, usually measured in inches. Three trials are done and the average of the last two is noted

  Four weeks

Secondary Outcomes (4)

• Berg Balance Scale

  Four weeks

• 36-Item Short Form Survey (SF-36)

  Four weeks

• Spinal Cord Independence Measure (SCIM)

  Four weeks

• Trunk Stability Measurement

  Four weeks

Study Arms (2)

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.

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.

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, 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: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc Physiotherapist

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 12, 2025
• Study Start: February 10, 2025
• Primary Completion: September 21, 2025
• Study Completion: September 21, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)