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Hunova® Randomized Controlled Trial for Trunk Control Improvement in Spinal Cord Injured Patients

NCT05887752 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2025-09-16

No results posted yet for this study

Summary

In patients with Spinal Cord Injury (SCI), trunk and therefore postural control (both in statics and dynamics) are impaired, often with strong consequences on daily life activities. Therefore, improvement and reinforcement of trunk control are primary rehabilitation (rehab) goals.

For the evaluation of trunk control in SCI people, still today no tests and scales are definable as gold standards.

Nowadays, for evaluation and rehab purposes of trunk control, balance and proprioception, in both sitting and standing positions, conventional rehabilitation can be supplemented with robotic treatments, e.g. through the Hunova® device (by Movendo Technology). Several studies have demonstrated that conventional rehab associated with robotic training is able to influence functional and motor outcomes in stroke patients, while little evidence is available on SCI patients, also on the number of robotic sessions needed.

The present randomized controlled study primarily aims to demonstrate the effects on trunk control of an integrated rehab treatment (standard plus Hunova®), compared to the standard alone and to gain evidence on the better rehabilitation scheme in terms of number of Hunova® sessions. The correlation between the variation of trunk control, measured by the output data of the Hunova® device itself - ideally more objective - and that assessed through a validated clinical scale, will also be estimated.

Conditions

  • Spinal Cord Injury

Interventions

OTHER

Standard rehabilitation

Carried out 3h/day, 5 days/week at the Montecatone Institute. It implies a multiprofessional approach through: * physiotherapy; * occupational therapy; * sports rehabilitation.

DEVICE

Hunova® rehabilitation

Performed in a dedicated gym of the Montecatone Institute, 1 hour/day, 5 days/week, in the presence of a physiotherapist. Depending on the improvement of the person and of his skills acquisition, the degree of tilting of the Hunova® seat in the various planes may vary.

Sponsors & Collaborators

  • Montecatone Rehabilitation Institute S.p.A.

    lead OTHER

Principal Investigators

  • Ilaria Baroncini, MD · Montecatone Rehabilitation Institute S.p.A.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-05
Primary Completion
2026-03-31
Completion
2026-04-30

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 NCT05887752 on ClinicalTrials.gov