Enhancing Balance and Mobility in Incomplete Spinal Cord Injury
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Balance Training 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
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.
|
Outcome Measures
Primary Outcome Measures
- Berg Balance Scale [11 months]
Berg Balance Scale for balance assessment
Secondary Outcome Measures
- Ten-Meter Walking Test [11 months]
Ten-Meter Walking Test for overground walking speed assessment
- Timed Up and Go Test [11 months]
Timed Up and Go Test overground walking assessment
- Walking Index in Spinal Cord Injury II [11 months]
Walking Index in Spinal Cord Injury II for walking independence level assessment
- Modified Borg Scale [11 months]
Modified Borg Scale for subjective fatigue assessment
- Visual Analogue Scale [11 months]
Visual Analogue Scale (VAS) for fear of falling assessment
- Spinal Cord Independence Measure (SCIM III) [11 months]
Spinal Cord Independence Measure (SCIM III) for activity of daily living assessment
- World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF) [11 months]
World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF) for quality of life assessment
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ankara City Hospital | Ankara | Turkey | 06800 |
Sponsors and Collaborators
- Ankara City Hospital Bilkent
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- AnkaraCHBilkent-PMR-MSS-01