Spinal Cord Injury
Conditions
Keywords
Spinal Cord Injuries, Rehabilitation, Robotic, Postural Stability
Brief summary
The study aims to evaluate the effects of robotic-assisted gait training (Lokomat) on dynamic postural stability in patients with incomplete spinal cord injury (SCI). Participants will be randomized into two groups: one receiving robotic training and another receiving conventional postural stability exercises. The primary evaluation will use the Mini-BESTest, supplemented by objective gait analysis using wearable inertial sensors (IMUs) to measure symmetry, fluidity, and stability. A secondary objective is to compare these gait indices between SCI patients and healthy individuals.
Interventions
OTHERRobotic Rehabilitation
It is a robotic rehabilitation with Lokomat training.
OTHERControl
Conventional rehabilitation (Physiotherapy)
Sponsors
I.R.C.C.S. Fondazione Santa Lucia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Incomplete Spinal Cord Injury (ASIA scale C or D). * Traumatic or non-traumatic, subacute or chronic. * Walking Index for Spinal Cord Injury (WISCI) score \> 5. * Height ≤ 200 cm and Weight ≤ 135 kg.
Exclusion criteria
* Cognitive impairments preventing task comprehension. * Grade 2 or higher pressure ulcers. * Severe spasticity (Modified Ashworth Scale \> 2). * Orthopedic, vestibular, or other neurological comorbidities affecting gait. * Severe heart failure or cardiovascular instability.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mini-Balance Evaluation Systems Test (Mini-BESTest) Score | Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions). | Assessment of dynamic balance across 14 tasks (Score range: 0-28, with higher scores indicating better balance performance and lower fall risk). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Berg Balance Scale (BBS) | Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions). | Static and dynamic balance assessment (Score range: 0-56, with higher scores indicating better balance performance and lower fall risk). |
| Dynamic Gait Index (DGI) | Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions). | Ability to modify gait in response to task demands (Score range: 0-24, with higher scores indicating better balance performance and lower fall risk). |
| Inertial Measurement Unit (IMU)-derived Gait Parameters | Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions). | Quantitative measures spatiotemporal gait parameters |
| IMU-derived Gait Parameters - Root Mean Square | Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions). | Quantitative measures of dynamic postural stability (Root Mean Square) |
| IMU-derived Gait Parameters -Improved Harmonic Ratio | Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions). | Quantitative measures of simmetry of gait (Improved Harmonic Ratio) |
| IMU-derived Gait Parameters -log dimensionless jerk | Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions). | Quantitative measures of smoothness of gait (log dimensionless jerk) |
Countries
Italy
Outcome results
None listed