NCT07621900

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
18mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
May 2026Dec 2027

First Submitted

Initial submission to the registry

May 15, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

May 15, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 2, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

June 2, 2026

Status Verified

May 1, 2026

Enrollment Period

12 months

First QC Date

May 15, 2026

Last Update Submit

June 1, 2026

Conditions

Spinal Cord Injury

Keywords

Spinal Cord InjuriesRehabilitationRoboticPostural Stability

Outcome Measures

Primary Outcomes (1)

  • 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).

Secondary Outcomes (6)

  • Berg Balance Scale (BBS)

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

  • Dynamic Gait Index (DGI)

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

  • Inertial Measurement Unit (IMU)-derived 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

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

  • IMU-derived Gait Parameters -Improved Harmonic Ratio

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

  • +1 more secondary outcomes

Study Arms (2)

Intervention (Robotic)

EXPERIMENTAL

12 sessions (3x/week, 40 min) of robotic gait training with adaptive speed, body weight support, and assistance levels.

Other: Robotic Rehabilitation

Control (Usual Care)

ACTIVE COMPARATOR

12 sessions (3x/week, 40 min) focused on sensorimotor recovery and non-robotic dynamic postural stability exercises.

Other: Control

Interventions

Robotic RehabilitationOTHER

It is a robotic rehabilitation with Lokomat training.

Intervention (Robotic)
ControlOTHER

Conventional rehabilitation (Physiotherapy)

Control (Usual Care)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santa Lucia Foundation, Scientific Institute for Research and Health Care

Roma, RM, 00179, Italy

Location

Related Publications (2)

  • 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.

    PMID: 35741599BACKGROUND

  • 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.

    PMID: 37941214BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2026

First Posted

June 2, 2026

Study Start

May 15, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

June 2, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)