Spinal Cord Injuries, Walking, Difficulty
Conditions
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.
Interventions
DEVICEBalance 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.
Sponsors
Ankara City Hospital Bilkent
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Berg Balance Scale | 11 months | Berg Balance Scale for balance assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Ten-Meter Walking Test | 11 months | Ten-Meter Walking Test for overground walking speed 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 |
| Visual Analogue Scale | 11 months | Visual Analogue Scale (VAS) for fear of falling assessment |
Countries
Turkey (Türkiye)
Outcome results
None listed