Exploring the role of therapist-patient interaction in robotic gait rehabilitation for spinal cord injury
Patient-therapist INTERaction During RObotic GAIT Rehabilitation After Spinal Cord Injury: Clinical, Instrumental and Hyperscanning Study.
This study is testing if having more interaction with physical therapists during robotic walking therapy helps people with spinal cord injuries recover better than having less interaction.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | I.R.C.C.S. Fondazione Santa Lucia Academic / other |
| Locations | 1 site (Roma, Rome) |
| Trial ID | NCT06531304 on ClinicalTrials.gov |
What this trial studies
This study investigates how different levels of interaction between physical therapists and patients affect the outcomes of robotic-assisted gait rehabilitation in individuals with incomplete spinal cord injuries. It is designed as a single-blind randomized controlled trial with two groups: one receiving high levels of therapist-patient interaction and the other receiving minimal interaction during treatment with the Lokomat device. The goal is to determine if maximizing therapist-patient interaction leads to better rehabilitation results. The study emphasizes the importance of active patient involvement and feedback from therapists in enhancing recovery.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with incomplete spinal cord injuries at or above the T12 level, who are either in the subacute or chronic phase of recovery.
Not a fit: Patients with severe cognitive impairments or those who do not meet the clinical requirements for using the Lokomat may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve rehabilitation outcomes for patients with spinal cord injuries by optimizing therapist-patient interactions during robotic gait training.
How similar studies have performed: Other studies have shown promising results in robotic-assisted rehabilitation, but the specific focus on therapist-patient interaction in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Roma, Rome
- I.R.C.C.S. Fondazione Santa Lucia — Roma, Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Federica Tamburella — I.R.C.C.S. Fondazione Santa Lucia
- Study coordinator: Federica Tamburella, Professor
- Email: f.tamburella@hsantalucia.it
- Phone: 0651501678
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.