Spinal Cord InjuryNCT07621900
Effects of Lokomat Training on Dynamic Postural Stability in Incomplete Spinal Cord Injury
A study testing Robotic Rehabilitation in people with Spinal Cord Injury, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Robotic Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 15 May 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Santa Lucia Foundation, Scientific Institute for Research and Health Care
Roma, RM, 00179
About this study
Official 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
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.
- Conditions
- Spinal Cord Injury
- Being tested
- Robotic Rehabilitation, Control
- Keywords
- Spinal Cord Injuries, Rehabilitation, Robotic, Postural Stability
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic RehabilitationOther
It is a robotic rehabilitation with Lokomat training.
ControlOther
Conventional rehabilitation (Physiotherapy)
| Study group | Role | What they receive |
|---|---|---|
| Intervention (Robotic) | Experimental | 12 sessions (3x/week, 40 min) of robotic gait training with adaptive speed, body weight support, and assistance levels. Receives: 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions).
Secondary outcomes (6)
Berg Balance Scale (BBS)
Static and dynamic balance assessment (Score range: 0-56, with higher scores indicating better balance performance and lower fall risk).
Measured: Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions).
Dynamic Gait Index (DGI)
Ability to modify gait in response to task demands (Score range: 0-24, with higher scores indicating better balance performance and lower fall risk).
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start15 May 2026
- Primary completion1 May 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621900
- Sponsor's protocol ID
- 418/SL/25
- Status last verified
- May 2026
- First submitted
- 15 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35741599Di 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.
PubMed 37941214
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07621900
- Acronym / sponsor ID
- 418/SL/25
- Conditions
- Spinal Cord Injury
- Keywords
- Spinal Cord Injuries, Rehabilitation, Robotic, Postural Stability
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- I.R.C.C.S. Fondazione Santa LuciaUniversity, hospital or other
- Study start
- 15 May 2026 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (Robotic) | Experimental | Other: Robotic Rehabilitation12 sessions (3x/week, 40 min) of robotic gait training with adaptive speed, body weight support, and assistance levels. |
| Control (Usual Care) | Active comparator | Other: Control12 sessions (3x/week, 40 min) focused on sensorimotor recovery and non-robotic dynamic postural stability exercises. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic RehabilitationIt is a robotic rehabilitation with Lokomat training. | Other | Intervention (Robotic) |
| ControlConventional rehabilitation (Physiotherapy) | Other | Control (Usual Care) |
Primary outcome
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).
6 secondary outcomes
Berg Balance Scale (BBS)
Time frame: Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions).
Dynamic Gait Index (DGI)
Time frame: Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions).
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).
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).
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).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Background: PubMed 35741599Lorusso 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.
- Background: PubMed 37941214Di 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Rehabilitation in people with Spinal Cord Injury, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07621900, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.