Effects of Wheelchair Treadmill and Conventional Exercises on Trunk Balance in Spinal Cord Injury Patients

NCT06876285 | Recruiting

• 1 other identifier: TABED 1-24- 347
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

postural balance; quality of life; functional indenpence

Outcome Measures

Primary Outcomes (1)

• Modified Functional Reach Test

  During this test, the participant is seated on a chair with back support, with hips, knees, and feet positioned at 90-degree flexion and feet flat on the ground. A measuring tape is fixed to the wall at the level of the participant's acromion. The participant is instructed to bring their dominant arm to 90-degree flexion, and the initial measurement is recorded. The reference point for measurement is the styloid process of the ulna. Subsequently, the participant is asked to reach forward as far as possible. The contralateral hand is placed on the umbilicus to prevent compensatory stabilization.

  4 weeks

Secondary Outcomes (5)

• Trunk Control Test

  4 weeks

• Spinal Cord Independence Measure

  4 weeks

• Quebec Assistive Technology User Satisfaction Assessment

  4 weeks

• The 36-Item Short Form Survey

  4 weeks

• Visual Analog Scale

  4 weeks

Study Arms (2)

control group

Both groups will receive conventional physiotherapy, routinely administered in the clinic for 40 minutes, five days per week. Additional training sessions are planned for patients included in the study. Patients in the control group will receive at least 20 minutes of wheelchair propulsion training on a flat surface at least three days per week, in addition to the standard treatment. They will complete a total of 10 sessions within a maximum duration of four weeks.

experimental group

Both groups will receive conventional physiotherapy, routinely administered in the clinic for 40 minutes, five days per week. Additional training sessions are planned for patients included in the study. Patients in the experimental group will participate in wheelchair treadmill training for at least 20 minutes per session, at least three days per week. They will complete a total of 10 treadmill training sessions within a maximum duration of four weeks.

Eligibility Criteria

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

Study Population

ankara bilkent city hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

RECRUITING

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

Central Study Contacts

sinem yıldırım

CONTACT

+905433074489; sinemakyuz00@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.Sc. physiotherapist

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 14, 2025
• Study Start: January 6, 2025
• Primary Completion: November 6, 2025
• Study Completion: December 6, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)