Enhancing Balance and Mobility in Incomplete Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

Official title:

Enhancing Balance and Mobility in Incomplete Spinal Cord Injury With an Overground Gait Trainer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06137443
• Other study ID #: AnkaraCHBilkent-PMR-MSS-01
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: November 1, 2022

Study information

• Verified date: November 2023
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare the effects of balance therapy with an overground gait trainer in incomplete spinal cord injury (SCI). The main questions it aims to answer are:

• Is balance therapy with an overground gait trainer effective in improving functional ambulation in SCI?

• Is balance therapy with an overground gait trainer effective in enhancing Activities of Daily Living in SCI?

Participants treated with either:

• Overground gait trainer along with conventional exercise therapy

Description:

Background: Spinal Cord Injury (SCI) and similar pathologies not only negatively affect a person's ability to walk but also have adverse effects on their participation in social, vocational, and recreational activities. The correction of walking impairments resulting from SCI is one of the most important goals of rehabilitation, as it is essential for a person's social and vocational integration. When considering balance function, the use of challenging balance and walking exercises at an adequate level is necessary to trigger motor learning. Ensuring the patient's safety is the primary priority when using advanced balance and walking exercises based on the patient's current condition. In this study, Andago V2.0 (Hocoma AG, Volketswil, Switzerland) has been preferred for ensuring safety by adapting to patient movements. The main objective of the study was to assess the impact of Andago on balance in patients with motor incomplete SCI. The secondary aim was to evaluate its influence on quality of life and independence. Methods: The study included five participants who were over 18 years of age and had experienced a spinal injury within the past year. These participants were classified as AIS D (American Spinal Injury Association Impairment Scale). Patients underwent eight-week treatment, with walking and balance exercises on Andago performed three days a week. In addition, conventional in-bed exercises, including stretching, strengthening, and mobility exercises, were administered for 40 minutes, two days a week. Modified Borg Scale (MBS), Ten-Meter Walking Test (10MWT), Timed Up and Go Test (TUG), Walking Index in Spinal Cord Injury II (WISCI II), Berg Balance Scale (BBS), Visual Analogue Scale (VAS) for fear of falling, Spinal Cord Independence Measure (SCIM III), World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF) were used for evaluation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Spinal Cord Injured below T4

• Time from injury < 1 year

• D level on AIS (American Spinal Injury Association Impairment Scale)

• Patients with spinal stabilization

Exclusion Criteria:

• Osteoporosis

• An implanted electronic device

• other neurological diseases

• Cardio-pulmonary diseases

• Orthopedic diseases

Related Conditions & MeSH terms

• Mobility Limitation
• Spinal Cord Injuries
• Walking, Difficulty
• Wounds and Injuries

Intervention

Device:
• Balance Training
Patients underwent treatment for eight weeks, with walking and balance exercises on Andago performed three days a week. In addition, conventional in-bed exercises, including stretching, strengthening, and mobility exercises, were administered for 40 minutes, two days a week.

Locations

Country	Name	City	State
Turkey	Ankara City Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

Contreras-Vidal JL, A Bhagat N, Brantley J, Cruz-Garza JG, He Y, Manley Q, Nakagome S, Nathan K, Tan SH, Zhu F, Pons JL. Powered exoskeletons for bipedal locomotion after spinal cord injury. J Neural Eng. 2016 Jun;13(3):031001. doi: 10.1088/1741-2560/13/3/031001. Epub 2016 Apr 11. — View Citation

Esquenazi A, Talaty M, Packel A, Saulino M. The ReWalk powered exoskeleton to restore ambulatory function to individuals with thoracic-level motor-complete spinal cord injury. Am J Phys Med Rehabil. 2012 Nov;91(11):911-21. doi: 10.1097/PHM.0b013e318269d9a3. — View Citation

Finlayson ML, Peterson EW. Falls, aging, and disability. Phys Med Rehabil Clin N Am. 2010 May;21(2):357-73. doi: 10.1016/j.pmr.2009.12.003. — View Citation

Fouad K, Tetzlaff W. Rehabilitative training and plasticity following spinal cord injury. Exp Neurol. 2012 May;235(1):91-9. doi: 10.1016/j.expneurol.2011.02.009. Epub 2011 Feb 17. — View Citation

Hayta E, Elden H. Acute spinal cord injury: A review of pathophysiology and potential of non-steroidal anti-inflammatory drugs for pharmacological intervention. J Chem Neuroanat. 2018 Jan;87:25-31. doi: 10.1016/j.jchemneu.2017.08.001. Epub 2017 Aug 10. — View Citation

Leech KA, Kinnaird CR, Holleran CL, Kahn J, Hornby TG. Effects of Locomotor Exercise Intensity on Gait Performance in Individuals With Incomplete Spinal Cord Injury. Phys Ther. 2016 Dec;96(12):1919-1929. doi: 10.2522/ptj.20150646. Epub 2016 Jun 16. — View Citation

Yu P, Zhang W, Liu Y, Sheng C, So KF, Zhou L, Zhu H. The effects and potential mechanisms of locomotor training on improvements of functional recovery after spinal cord injury. Int Rev Neurobiol. 2019;147:199-217. doi: 10.1016/bs.irn.2019.08.003. Epub 2019 Sep 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Berg Balance Scale	Berg Balance Scale for balance assessment	11 months
Secondary	Ten-Meter Walking Test	Ten-Meter Walking Test for overground walking speed assessment	11 months
Secondary	Timed Up and Go Test	Timed Up and Go Test overground walking assessment	11 months
Secondary	Walking Index in Spinal Cord Injury II	Walking Index in Spinal Cord Injury II for walking independence level assessment	11 months
Secondary	Modified Borg Scale	Modified Borg Scale for subjective fatigue assessment	11 months
Secondary	Visual Analogue Scale	Visual Analogue Scale (VAS) for fear of falling assessment	11 months
Secondary	Spinal Cord Independence Measure (SCIM III)	Spinal Cord Independence Measure (SCIM III) for activity of daily living assessment	11 months
Secondary	World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF)	World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF) for quality of life assessment	11 months