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Completed

NCT Number: NCT06137443

Enhancing Balance and Mobility in Incomplete Spinal Cord Injury

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

Completed

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Mobility Limitation Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Trauma, Nervous System Walking, Difficulty Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Berg Balance Scale

    Time frame: 11 months

    Berg Balance Scale for balance assessment

Secondary outcomes

  1. Ten-Meter Walking Test

    Time frame: 11 months

    Ten-Meter Walking Test for overground walking speed assessment

  2. Timed Up and Go Test

    Time frame: 11 months

    Timed Up and Go Test overground walking assessment

  3. Walking Index in Spinal Cord Injury II

    Time frame: 11 months

    Walking Index in Spinal Cord Injury II for walking independence level assessment

  4. Modified Borg Scale

    Time frame: 11 months

    Modified Borg Scale for subjective fatigue assessment

  5. Visual Analogue Scale

    Time frame: 11 months

    Visual Analogue Scale (VAS) for fear of falling assessment

  6. Spinal Cord Independence Measure (SCIM III)

    Time frame: 11 months

    Spinal Cord Independence Measure (SCIM III) for activity of daily living assessment

  7. World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF)

    Time frame: 11 months

    World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF) for quality of life assessment

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 18, 2023
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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