NCT06531304 Patient-therapist INTERaction During RObotic GAIT Rehabilitation After Spinal Cord Injury
| NCT ID | NCT06531304 |
| Status | Recruiting |
| Phase | — |
| Sponsor | I.R.C.C.S. Fondazione Santa Lucia |
| Condition | Spinal Cord Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-06-05 |
| Primary Completion | 2025-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2024-06-05 with a primary completion date of 2025-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
INTERROGAIT will disentangle the role of Physical Therapist - Patient (Pht-Pt) interaction in robotic assisted gait rehabilitation in spinal cord injury patients. The study is structured as a single blind randomized controlled trial with two arms, in which effects of different Pht-Pt interaction levels will be assessed on the ongoing robotic treatment with the Lokomat device. The main hypothesis is that when Pht-Pt interaction is maximized (experimental group), this will allow to better rehabilitation outcome with respect to a minimun level of Pht-Pt interaction (control group).
Eligibility Criteria
Inclusion Criteria: * incomplete SCI lesion (ISNCSCI AIS level C or D); * subacute or chronic iSCI; * traumatic and non-traumatic aetiology; * SCI at or above T12 level; * absence of severe cognitive impairment such as to interfere with the protocol. Exclusion Criteria: * lack of the clinical requirements for using Lokomat; * anything preventing EEG recording.
Contact & Investigator
Federica Tamburella
PRINCIPAL INVESTIGATOR
I.R.C.C.S. Fondazione Santa Lucia
Frequently Asked Questions
Who can join the NCT06531304 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Spinal Cord Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06531304 currently recruiting?
Yes, NCT06531304 is actively recruiting participants. Contact the research team at f.tamburella@hsantalucia.it for enrollment information.
Where is the NCT06531304 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT06531304 clinical trial?
NCT06531304 is sponsored by I.R.C.C.S. Fondazione Santa Lucia. The principal investigator is Federica Tamburella at I.R.C.C.S. Fondazione Santa Lucia. The trial plans to enroll 30 participants.