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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention (Robotic) | Experimental | 12 sessions (3x/week, 40 min) of robotic gait training with adaptive speed, body weight support, and assistance levels. |
|
| Control (Usual Care) | Active Comparator | 12 sessions (3x/week, 40 min) focused on sensorimotor recovery and non-robotic dynamic postural stability exercises. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic Rehabilitation | Other | It is a robotic rehabilitation with Lokomat training. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mini-Balance Evaluation Systems Test (Mini-BESTest) Score | Assessment of dynamic balance across 14 tasks (Score range: 0-28, with higher scores indicating better balance performance and lower fall risk). | Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions). |
| Measure | Description | Time Frame |
|---|---|---|
| Berg Balance Scale (BBS) | Static and dynamic balance assessment (Score range: 0-56, with higher scores indicating better balance performance and lower fall risk). | Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions). |
| Dynamic Gait Index (DGI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Lucia Foundation, Scientific Institute for Research and Health Care | Roma | RM | 00179 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35741599 | Background | Lorusso M, Tramontano M, Casciello M, Pece A, Smania N, Morone G, Tamburella F. Efficacy of Overground Robotic Gait Training on Balance in Stroke Survivors: A Systematic Review and Meta-Analysis. Brain Sci. 2022 May 31;12(6):713. doi: 10.3390/brainsci12060713. | |
| 37941214 | Background | Di Tommaso F, Tamburella F, Lorusso M, Gastaldi L, Molinari M, Tagliamonte NL. Biomechanics of Exoskeleton-Assisted Treadmill Walking. IEEE Int Conf Rehabil Robot. 2023 Sep;2023:1-6. doi: 10.1109/ICORR58425.2023.10304685. |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| Control | Other | Conventional rehabilitation (Physiotherapy) |
|
Ability to modify gait in response to task demands (Score range: 0-24, with higher scores indicating better balance performance and lower fall risk). |
| Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions). |
| Inertial Measurement Unit (IMU)-derived Gait Parameters | Quantitative measures spatiotemporal gait parameters | Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions). |
| IMU-derived Gait Parameters - Root Mean Square | Quantitative measures of dynamic postural stability (Root Mean Square) | Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions). |
| IMU-derived Gait Parameters -Improved Harmonic Ratio | Quantitative measures of simmetry of gait (Improved Harmonic Ratio) | Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions). |
| IMU-derived Gait Parameters -log dimensionless jerk | Quantitative measures of smoothness of gait (log dimensionless jerk) | Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions). |
| D014947 | Wounds and Injuries |