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Spinal Cord InjuriesNCT06137443

Enhancing Balance and Mobility in Incomplete Spinal Cord Injury

A study testing Balance Training in people with Spinal Cord Injuries and Walking, Difficulty, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Spinal Cord Injuries, Walking, Difficulty
What is being tested?
Balance Training
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2022to 1 Nov 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Ankara City Hospital

    Ankara, 06800

Other trials in Turkey (Türkiye)

About this study

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

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
Read the 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.

Being tested
Balance Training
Medical subject headings
Spinal Cord Injuries, Mobility Limitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Balance TrainingDevice

    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.

Study groups in NCT06137443
Study groupRoleWhat they receive
Balance TrainingExperimentalThe 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.
Receives: Device: Balance Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Berg Balance Scale

    Berg Balance Scale for balance assessment

    Measured: 11 months

Secondary outcomes (7)

  1. Ten-Meter Walking Test

    Ten-Meter Walking Test for overground walking speed assessment

    Measured: 11 months

  2. Timed Up and Go Test

    Timed Up and Go Test overground walking assessment

    Measured: 11 months

  3. Walking Index in Spinal Cord Injury II

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

    Measured: 11 months

  4. Modified Borg Scale

    Modified Borg Scale for subjective fatigue assessment

    Measured: 11 months

  5. Visual Analogue Scale

    Visual Analogue Scale (VAS) for fear of falling assessment

    Measured: 11 months

  6. Spinal Cord Independence Measure (SCIM III)

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

    Measured: 11 months

  7. 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

    Measured: 11 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start1 Jan 2022
  3. Primary completion1 Nov 2022
  4. Study completion1 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06137443
Sponsor's protocol ID
AnkaraCHBilkent-PMR-MSS-01
Status last verified
Nov 2023
First submitted
14 Nov 2023
Last updated
18 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 31607355

  • 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.

    PubMed 28803968

  • 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.

    PubMed 20494282

  • 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.

    PubMed 27064508

  • 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.

    PubMed 23085703

  • 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.

    PubMed 21333646

  • 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.

    PubMed 27313241

Questions about this trial

What is this clinical trial studying?

A study testing Balance Training in people with Spinal Cord Injuries and Walking, Difficulty, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Berg Balance Scale (time frame: 11 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06137443, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.

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