RecruitingNot ApplicableNCT06531304

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

Patient-therapist INTERaction During RObotic GAIT Rehabilitation After Spinal Cord Injury: Clinical, Instrumental and Hyperscanning Study.

Sponsor

I.R.C.C.S. Fondazione Santa Lucia

Enrollment

30 participants

Start Date

Jun 5, 2024

Study Type

INTERVENTIONAL

Conditions

Spinal Cord Injuries

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

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria5

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 Criteria2

lack of the clinical requirements for using Lokomat;
anything preventing EEG recording.

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Interventions

DEVICELokomat 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.