Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05887752

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

Led by Montecatone Rehabilitation Institute S.p.A. · Updated on 2025-09-16

78

Participants Needed

1

Research Sites

147 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Spinal Cord Injury of any cause
  • American Spinal Injury (AIS) grade A or B with neurological level T1 or below
  • Alternatively, AIS grade C or D with neurological level C4 or below
  • Stable clinical condition
  • Injury occurred within the last 6 months
  • Ability to sit continuously for at least 1 hour
  • Able to understand and provide informed consent personally
Not Eligible

You will not qualify if you...

  • Use of tracheal cannula requiring bronchoaspiration
  • Use of spine orthosis
  • Spine or lower limb instability or significant deformity
  • Presence of paraosteoarthropathy in active or inflammatory phase
  • Stage 3 or higher ischial pressure lesion according to NPUAP/EPUAP classification
  • Requirement of a lifter for patient transfers
  • Body weight of 150 kg or more

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Montecatone Rehabilitation Institute S.p.A.

Imola, BO, Italy, 40026

Actively Recruiting

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Research Team

I

Ilaria Baroncini, MD

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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