Enhancing Balance and Mobility in Incomplete Spinal Cord Injury

NCT ID: NCT06137443

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2022-11-01

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

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.

Conditions

Spinal Cord Injuries; Walking, Difficulty

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Balance Training

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ankara City Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 21333646 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27313241 (View on PubMed)

Other Identifiers

AnkaraCHBilkent-PMR-MSS-01

Identifier Type: -

Identifier Source: org_study_id