Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT06531304

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

Led by I.R.C.C.S. Fondazione Santa Lucia · Updated on 2024-07-31

30

Participants Needed

1

Research Sites

51 weeks

Total Duration

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Sponsors

I

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

Lead Sponsor

U

University of Roma La Sapienza

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Incomplete spinal cord injury lesion (ISNCSCI AIS level C or D)
  • Subacute or chronic incomplete spinal cord injury
  • Traumatic or non-traumatic cause of spinal cord injury
  • Spinal cord injury at or above T12 level
  • No severe cognitive impairment interfering with the study protocol
Not Eligible

You will not qualify if you...

  • Not meeting clinical requirements for using the Lokomat device
  • Any condition preventing EEG recording

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Roma, Rome, Italy, 00179

Actively Recruiting

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Research Team

F

Federica Tamburella, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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