Clinical trial NCT06876285: Effects of Wheelchair Treadmill and Conventional Exercises on Trunk Balance in Spinal Cord Injury Patients
Official title: Examination of the Effects of Wheelchair Treadmill Exercise and Conventional Wheelchair Exercises on Trunk Balance in Patients with Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Cord Injury
Keywords: postural balance
quality of life
functional indenpence
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ankara bilkent city hospital

Brief summary: This study aims to determine whether wheelchair treadmill exercises improve trunk balance and stability compared to conventional wheelchair exercises. Trunk balance is essential for mobility, transfers, and daily activities in individuals with spinal cord injury (SCI). The study includes individuals with SCI who use manual wheelchairs. Participants will be randomly assigned to: A control group performing conventional wheelchair exercises, an experimental group performing wheelchair treadmill exercises. Researchers will measure trunk balance, daily independence, wheelchair satisfaction, quality of life, and fear of falling. This research will help identify better rehabilitation methods for people with SCI.

This study is a prospective observational study. Regardless of whether the exercises are performed conventionally or using an alternative platform such as a wheelchair treadmill, all interventions included in the study are routine clinical practices. Patients whose treatment programs already adhere to the aforementioned procedures will be included in the study. In the Upper Extremity and Hand Rehabilitation Laboratory, where the wheelchair treadmill is available, patients with spinal cord injuries undergo a standardized rehabilitation program as part of routine clinical practice. This laboratory operates on a scheduled appointment basis.

After random allocation into groups, patients in the experimental group will be assessed at the beginning and end of the wheelchair treadmill therapy. Meanwhile, patients in the control group will be enrolled in the study before initiating wheelchair treadmill therapy. Once the data from the control group have been collected, these patients will also have the opportunity to receive wheelchair treadmill therapy.

Detailed description: Our study is a prospective observational study. Regardless of whether the exercises are performed conventionally or using an alternative platform such as a wheelchair treadmill, all interventions included in the study are routine clinical practices. Patients whose treatment programs already adhere to the aforementioned procedures will be included in the study. In the Upper Extremity and Hand Rehabilitation Laboratory, where the wheelchair treadmill is available, patients with spinal cord injuries undergo a standardized rehabilitation program as part of routine clinical practice. This laboratory operates on a scheduled appointment basis.

After random allocation into groups, patients in the experimental group will be assessed at the beginning and end of the wheelchair treadmill therapy. Meanwhile, patients in the control group will be enrolled in the study before initiating wheelchair treadmill therapy. Once the data from the control group have been collected, these patients will also have the opportunity to receive wheelchair treadmill therapy.

The wheelchair treadmill to be utilized in the study is the h/p/cosmos saturn® 300/100 r model. The device includes two separate safety belts for the participant and the wheelchair, along with a wheelchair stabilizer equipped with three different locking mechanisms. Additionally, three emergency stop buttons located in different areas ensure maximum patient safety.

Treadmill exercises will be conducted at a submaximal level with a 0.7% incline. Heart rate will be monitored using a portable device. Regardless of whether the exercises are performed conventionally or on a treadmill, all exercises are part of routine clinical practice. Patients already receiving treatment in accordance with the aforementioned procedure will be included in the study. Participants will be randomly assigned to groups.

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. Exercise interventions will be carried out by two experienced physiotherapists working at the hospital. The patients' data will also be collected by these two physiotherapists.

Volunteers will be assessed at Ankara City Hospital Physical Therapy and Rehabilitation Hospital, within the Spinal Cord Injury Rehabilitation Neurophysiological Exercise Laboratory and the Upper Extremity and Hand Rehabilitation Laboratory, utilizing the treadmill available in the facility's sports hall.

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 another 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.

To determine the appropriate sample size, 10 patients per group will be included. Based on the obtained pilot data, a power analysis will be conducted using the G\* Power program (version 3.0.10, Universität Düsseldorf, Düsseldorf, Germany).

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 18 years or older
* SCI at the T6 level or below
* Classified as ASIA A or B
* Manual wheelchair user for at least four weeks
* Spinal stabilization achieved
* Voluntary consent to participate

Exclusion Criteria:

* Presence of osteoporosis
* Presence of cardiopulmonary disease
* Presence of a neurological condition other than SCI
* Presence of a musculoskeletal disorder affecting the joints or surrounding tissues
* Presence of orthostatic hypotension

Primary outcomes:
measure: Modified Functional Reach Test
timeFrame: 4 weeks
Secondary outcomes:
measure: Trunk Control Test
timeFrame: 4 weeks
measure: Spinal Cord Independence Measure
timeFrame: 4 weeks
measure: Quebec Assistive Technology User Satisfaction Assessment
timeFrame: 4 weeks
measure: The 36-Item Short Form Survey
timeFrame: 4 weeks
measure: Visual Analog Scale
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
Study officials:
References: