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Patient-therapist INTERaction During RObotic GAIT Rehabilitation After Spinal Cord Injury

NCT06531304 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-07-31

No results posted yet for this study

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).

Conditions

  • Spinal Cord Injuries

Interventions

DEVICE

Lokomat Robot Assisted Gait Training

Patients will underwent 12 RAGT training sessions (3 times/week for 4 consecutive weeks, 45 min each including the time for wearing the harness and the exoskeleton) with the Lokomat device as add-on to conventional regimen (5 times/week, 80 min each). The Lokomat is a technologically advanced robot-assisted gait training device. Patients are supported in a harness above a treadmill while the robotic device assists the movements of their legs to provide physiological gait. As treatment progresses, weight bearing is increased and assistance from the robotic legs is reduced, requiring the patient to gradually assume greater responsibility for movements needed during walking.

Sponsors & Collaborators

  • University of Roma La Sapienza

    collaborator OTHER

  • I.R.C.C.S. Fondazione Santa Lucia

    lead OTHER

Principal Investigators

  • Federica Tamburella · I.R.C.C.S. Fondazione Santa Lucia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-05
Primary Completion
2025-05-31
Completion
2025-05-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06531304 on ClinicalTrials.gov