Enhancing Balance and Mobility in Incomplete Spinal Cord Injury

NCT06137443 | Completed

• 1 other identifier: AnkaraCHBilkent-PMR-MSS-01
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Spinal Cord Injuries; Walking, Difficulty

Outcome Measures

Primary Outcomes (1)

• Berg Balance Scale

  Berg Balance Scale for balance assessment

  11 months

Secondary Outcomes (7)

• Ten-Meter Walking Test

  11 months

• Timed Up and Go Test

  11 months

• Walking Index in Spinal Cord Injury II

  11 months

• Modified Borg Scale

  11 months

• Visual Analogue Scale

  11 months

Study Arms (1)

Balance Training

EXPERIMENTAL

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 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.

Device: Balance Training

Interventions

Balance Training DEVICE

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.

Balance Training

Eligibility Criteria

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

You may qualify if:

• Spinal Cord Injured below T4
• Time from injury \< 1 year
• D level on AIS (American Spinal Injury Association Impairment Scale)
• Patients with spinal stabilization

You may not qualify if:

• Osteoporosis
• An implanted electronic device
• other neurological diseases
• Cardio-pulmonary diseases
• Orthopedic diseases

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 31607355 BACKGROUND

• 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.

  PMID: 28803968 BACKGROUND

• 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.

  PMID: 20494282 BACKGROUND

• 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.

  PMID: 27064508 BACKGROUND

• 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.

  PMID: 23085703 BACKGROUND

• 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.

  PMID: 21333646 BACKGROUND

• 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.

  PMID: 27313241 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Mobility Limitation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 18, 2023
• Study Start: January 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

TU (1)