NCT05887752

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

Efficacy of Combined Treatment With Hunova® Instrumentation and Standard Rehabilitation, Compared to Standard Rehabilitation, on the Improvement of Trunk Control in Spinal Cord Injured Patients: Hunova® Randomized Controlled Trial
Montecatone Rehabilitation Institute S.p.A.·ClinicalTrials.gov·otherRecruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Spinal Cord Injury
Drug/Device/Intervention
Standard rehabilitation
Study type
Interventional
Intervention type
other
Sponsor & location
Primary sponsor
Montecatone Rehabilitation Institute S.p.A.
Location
Imola, Italy
Timeline & enrollment
Phase
N/A
Start date
Jun 05, 2023
End date
Apr 01, 2025
Enrollment
78 participants
Primary outcome

Change of trunk control after 10 sessions of Hunova® rehabilitation,Change of trunk equilibrium after 10 sessions of Hunova® rehabilitation

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.

ICD-10 classifications
Sequelae of injury of spinal cordOther injury of lumbar spinal cordInjury of spinal cord, level unspecifiedOther and unspecified injuries of thoracic spinal cordOther and unspecified injuries of cervical spinal cord
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05887752
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05887752 through Pure Global AI's free database. This phase not specified trial is sponsored by Montecatone Rehabilitation Institute S.p.A. and is currently Recruiting. The study focuses on Spinal Cord Injury. Target enrollment is 78 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.