Exoskeleton Training on Balance Control and Turning in Ambulation in Individuals With Incomplete Spinal Cord Injury

The Limits of Stability (LOS) test assesses dynamic balance using the Biodex Medical System. Participants stand on a stable platform (level 12) with feet positioned to maintain balance over the center. The test measures the time and accuracy as participants lean to intercept eight targets displayed at 45° intervals around a central point representing their center of pressure. Each target is randomly highlighted, and participants must reach each target as quickly and accurately as possible, returning to the center between attempts. Targets are set at 50% of the LOS based on participant height, and practice trials precede the main test. Participants can use handles briefly for balance recovery, but excessive reliance on them will terminate the test. Key outcomes include the time taken to reach targets and directional control, calculated as a percentage of accuracy. Three trials are recorded, and averaged values are used for statistical analysis.

The Modified Clinical Test of Sensory Integration and Balance (m-CTSIB) is assessed using the Biodex Balance SD (Biodex Medical System, Inc., New York, USA). This test evaluates the effects of sensory integration on standing balance across four conditions: eyes open on a firm surface, eyes closed on a firm surface, eyes open on a foam surface, and eyes closed on a foam surface. Each condition lasts 30 seconds, with a minimum 10-second rest period between trials as needed. Participants complete practice trials prior to the test trials, and the order of testing is randomized to minimize learning effects. Balance performance is quantified using the Sway Index (SI), where a higher SI indicates greater instability. The SI is recorded for each condition, along with a final overall SI. Three trials are conducted for each condition, and averages of the individual conditions and overall SI are calculated for data analysis.

A hand-held dynamometer will assess the strength of bilateral lower limbs (hip flexors, extensors, abductors, adductors, knee flexors, extensors, ankle dorsiflexors, and plantarflexors) in a lying position, as well as trunk muscles (flexors, extensors, and rotators) in a sitting position. Each muscle strength test will be performed three times, and the averaged values will be used for data analysis.

The Modified Ashworth Scale (MAS) assesses spasticity in various muscles bilaterally, including hip flexors, extensors, adductors, knee flexors, extensors, and ankle dorsiflexors and plantarflexors. Scores range from 0 to 5, where 0 indicates no spasticity and 5 indicates severe spasticity. Higher scores reflect worse outcomes in terms of spasticity levels.

The Modified Functional Reaching Test (MFRT) will assess participants' balance while seated on a chair without back or arm support. A yardstick will be positioned at the level of the acromion, with participants' feet flat on the ground. Starting with one shoulder flexed to 90 degrees, the ulnar styloid process will be the anatomical landmark for measuring reach. Participants will reach forward, backward, and laterally as far as possible without trunk rotation, with a research team member providing safety support. The maximum distance reached in centimeters for each direction will be recorded. Each direction will be tested three times, and the average value for each direction will be used for data analysis.

The Berg Balance Scale (BBS) assesses functional mobility and balance through 14 tasks evaluating both static and dynamic balance. Each task is scored on a 5-point ordinal scale from 0 to 4, with 0 indicating the lowest level of function and 4 the highest. The total score ranges from 0 to 56, with higher scores indicating better balance and functional mobility. Scoring is based on the participant's ability to meet specific time or distance requirements and to perform tasks independently. Participants wear their usual shoes and any necessary orthotics during testing, but they are not allowed to use walking assistive devices.

The Timed Up and Go Test (TUGT) is a test that involves various mobility activities that are common in daily life. When the test started, the subject should stand up from a seated position, walk straight forward for three meters, turn around, walk back to the starting position, and then sit down. The test will be repeated three times. The average time taken to complete the whole process will be used for data analysis.

10 Meter Walk Test (10MWT) is used to assess the walking speed of participants. Participants will be asked to walk at their maximum walking speed, with their usual walking aid if needed, for 10 meters. The initial and last two meters of the test will be allowed for acceleration and deceleration. The time required to walk for the intermediate six meters will be recorded. The average of three trials will be used for data analysis.

The Walking Index for Spinal Cord Injury II (WISCI II) is used to classify participants' level of walking independence and the use of assistive devices or braces. This 20-item scale ranges from 0, indicating that the participant is unable to walk, to 20, which signifies that the participant can ambulate 10 meters without assistance, devices, or braces. Higher scores reflect greater walking independence.

Fall history will be assessed with a semi-structured interview by asking the participants about occurrence and frequency of falls during the last 12 month. A fall is defined as any fall, including a slip or a trip, in which the participant came to rest on the floor, ground, or on a lower level. All falls are recorded through weekly self-reports by participants, during the intervention and follow-up.

The 36-Item Short Form Health Survey (SF-36) will be administered to participants to assess their quality of life. Participants will complete the survey, which consists of 36 questions covering eight health dimensions: physical functioning (PF), social functioning (SF), role physical (RP), role emotional (RE), mental health (MH), vitality (VT), bodily pain (BP), and general health (GH) perceptions. Responses will be scored on a standard 0 to 100 scale, where higher scores indicate better health-related quality of life (Forchheim et al., 2004). Data analysis will involve calculating overall total scores as well as individual scores for each dimension.

The Falls Efficacy Scale International (FES-I) is utilized to assess participants' concerns about falling during various daily activities. This scale comprises 16 items, each rated on a 4-point Likert scale from 1 (not at all concerned) to 4 (very concerned), resulting in a total score ranging from 16 (lowest concern) to 64 (highest concern), with higher scores indicating greater concern about falling. Thus, higher scores represent a worse outcome in terms of fall-related anxiety.

The Physical Activity Scale for Persons with Physical Disabilities (PASIPD) is used to assess physical activity participation. his 13-item questionnaire quantifies the level of physical activity across leisure, household, and occupational activities over the past seven days. A total score is calculated for data analysis, with potential scores ranging from 0 (no physical activity) to higher values reflecting greater levels of activity.