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

NCT06531304 | Recruiting

• 1 other identifier: GR-2019-12369207
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Spinal Cord Injuries

Keywords

Physical Therapist-Patient interaction; incomplete SCI; RAGT

Outcome Measures

Primary Outcomes (2)

• Changes in 10 Meters Walking Test (10MWT)

  Time test for gait speed assessment on short distance. The patients are instructed to walk a 10 meters distance, and the gait speed is calculated.

  Within 24 h before starting RAGT intervention (Pre) and within 24 hours from the twelfth Lokomat session (Post)

• Changes in Min Walking test (6MWT)

  Time test for gait speed assessment on long distance. The distance covered over a time of 6 minutes is recorded, and the gait speed is calculated

  Within 24 h before starting RAGT intervention (Pre) and within 24 hours from the twelfth Lokomat session (Post)

Secondary Outcomes (4)

• Changes in Walking Index for Spinal Cord Injury II (WISCI-II)

  Within 24 h before starting RAGT intervention (Pre) and within 24 hours from the twelfth Lokomat session (Post)

• Changes in Lower-extremity motor scores (LEMS) of American Spinal Cord Injury Association

  Within 24 h before starting RAGT intervention (Pre) and within 24 hours from the twelfth Lokomat session (Post)

• Changes in Modified Ashworth Scale (MAS)

  Within 24 h before starting RAGT intervention (Pre) and within 24 hours from the twelfth Lokomat session (Post)

• Changes in Independence in activities of daily living per the Spinal Cord Independence Measure III (SCIM-III)

  Within 24 h before starting RAGT intervention (Pre) and within 24 hours from the twelfth Lokomat session (Post)

Other Outcomes (2)

• Changes in Patient EEG spectral activity and Pht-Pt inter-brain connectivity

  Within 24 h before starting RAGT intervention (Pre) and within 24 hours from the twelfth Lokomat session (Post)

• Changes in Kinematic, Kinetic and Electromyography parameters

  Within 24 h before starting RAGT intervention (Pre) and within 24 hours from the twelfth Lokomat session (Post)

Study Arms (2)

EXP GROUP

EXPERIMENTAL

Patients will receive visual FB information about the Lokomat joint torque on the screen in front of him/her in order to adapt on-line hips and knees performances. In the EXP group, the Physical Therapist will receives also visual FB information and will guide the patient along the sessions with continuos verbal instructions, thus optimizing the PhT-Pt interaction with an high level of interaction. Patient will be asked to modify his/her hips or knees performances according to both the FB visualized on the screen and the information provided by the PhT.

Device: Lokomat Robot Assisted Gait Training

CTRL GROUP

ACTIVE COMPARATOR

Patients will receive visual FB information about the Lokomat joint torque on the screen in front of him/her in order to adapt on-line hips and knees performances, but the level on interaction between Patient and Physical Therapist will be reduced to its minimum because of no verbal instruction provided by the Physical Therapist to the patient. Consequently, patient will be asked to modify his/her hips or knees performances according only to the FB visualized on the screen, without no technical exchange with the Physical Therapist.

Device: Lokomat Robot Assisted Gait Training

Interventions

Lokomat Robot Assisted Gait Training DEVICE

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.

CTRL GROUP; EXP GROUP

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• I.R.C.C.S. Fondazione Santa Lucia: lead
• University of Roma La Sapienza: collaborator

Study Sites (1)

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

Roma, Rome, 00179, Italy

RECRUITING

Related Publications (17)

• Tamburella F, Moreno JC, Herrera Valenzuela DS, Pisotta I, Iosa M, Cincotti F, Mattia D, Pons JL, Molinari M. Influences of the biofeedback content on robotic post-stroke gait rehabilitation: electromyographic vs joint torque biofeedback. J Neuroeng Rehabil. 2019 Jul 23;16(1):95. doi: 10.1186/s12984-019-0558-0.

  PMID: 31337400 BACKGROUND

• Belda-Lois JM, Mena-del Horno S, Bermejo-Bosch I, Moreno JC, Pons JL, Farina D, Iosa M, Molinari M, Tamburella F, Ramos A, Caria A, Solis-Escalante T, Brunner C, Rea M. Rehabilitation of gait after stroke: a review towards a top-down approach. J Neuroeng Rehabil. 2011 Dec 13;8:66. doi: 10.1186/1743-0003-8-66.

  PMID: 22165907 BACKGROUND

• Tamburella F, Moreno JC, Iosa M, Pisotta I, Cincotti F, Mattia D, Pons JL, Molinari M. Boosting the traditional physiotherapist approach for stroke spasticity using a sensorized ankle foot orthosis: a pilot study. Top Stroke Rehabil. 2017 Sep;24(6):447-456. doi: 10.1080/10749357.2017.1318340. Epub 2017 May 1.

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MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Federica Tamburella

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Federica Tamburella, Professor

CONTACT

0651501678; f.tamburella@hsantalucia.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinical/Functional evaluation of patients will be performed by expert physiotherapists blinded to group allocation. Data analysis (EEG, EMG, Kinematic, Kientic) will be performed by neuroscientists blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, PhT, PhD

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: July 31, 2024
• Study Start: June 5, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)