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NCT Number: NCT07621900

Effects of Lokomat Training on Dynamic Postural Stability in Incomplete Spinal Cord Injury

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Santa Lucia Foundation, Scientific Institute for Research and Health Care

Roma, RM, 00179, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Robotic Rehabilitation

Other

It is a robotic rehabilitation with Lokomat training.

Control

Other

Conventional rehabilitation (Physiotherapy)

Primary outcomes

  1. Mini-Balance Evaluation Systems Test (Mini-BESTest) Score

    Time frame: 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 outcomes

  1. Berg Balance Scale (BBS)

    Time frame: 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).

  2. Dynamic Gait Index (DGI)

    Time frame: 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).

  3. Inertial Measurement Unit (IMU)-derived Gait Parameters

    Time frame: Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions).

    Quantitative measures spatiotemporal gait parameters

  4. IMU-derived Gait Parameters - Root Mean Square

    Time frame: 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)

  5. IMU-derived Gait Parameters -Improved Harmonic Ratio

    Time frame: 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)

  6. IMU-derived Gait Parameters -log dimensionless jerk

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

I.R.C.C.S. Fondazione Santa Lucia

Other

Registry information

Official study title

Evaluation of the Effects of Robotic Training on Dynamic Postural Stability, Symmetry, and Gait Smoothness in Subjects With Incomplete Spinal Cord Injury: a Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 2, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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