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Hunova® Randomized Controlled Trial for Trunk Control Improvement in Spinal Cord Injured Patients - Trial NCT05887752

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.

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NCT05887752
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Trial Details
ClinicalTrials.govNCT05887752
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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

Study Focus

Spinal Cord Injury

Standard rehabilitation

Interventional

other

Sponsor & Location

Montecatone Rehabilitation Institute S.p.A.

Imola, Italy

Timeline & Enrollment

N/A

Jun 05, 2023

Apr 01, 2025

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 cord
Other injury of lumbar spinal cord
Injury of spinal cord, level unspecified
Other and unspecified injuries of thoracic spinal cord
Other and unspecified injuries of cervical spinal cord

Data Source

ClinicalTrials.gov

NCT05887752

Non-Device Trial