Hunova® Randomized Controlled Trial for Trunk Control Improvement in Spinal Cord Injured Patients (NCT05887752) | Clinical Trial Compass
RecruitingNot Applicable
Hunova® Randomized Controlled Trial for Trunk Control Improvement in Spinal Cord Injured Patients
Italy78 participantsStarted 2023-06-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Spinal Cord Injury of any etiology;
* American Spinal Injury (AIS) grade A or B and American Spinal Injury Association (ASIA) neurological level T1 or below; alternatively AIS grade C or D and ASIA neurological level C4 or below;
* stable clinical conditions;
* maximum distance from the SCI event: 6 months;
* ability to maintain a sitting position for at least 1h continuously;
* subjects capable and collaborating, able to give in person their informed consent.
Exclusion Criteria:
* wearer of tracheal cannula, with the need for bronchoaspiration;
* wearer of spine orthosis;
* instability or significant deformity of the spine and/or of the lower limbs;
* presence of paraosteoarthropathy (POA) in development/inflammatory phase;
* presence of ischial Pressure Lesion (PL) of stage ≥ 3, according to the National Pressure Ulcer Advisory Panel / European Pressure Ulcer Advisory Panel (NPUAP/EPUAP) classification;
* need for a lifter for patient transfer;
* body weight ≥ 150 kg.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change of trunk control after 10 sessions of Hunova® rehabilitation
Timeframe: Baseline (initial assessment); 2 weeks after Baseline
2
Change of trunk equilibrium after 10 sessions of Hunova® rehabilitation
Timeframe: Baseline (initial assessment); 2 weeks after Baseline
Trial details
NCT IDNCT05887752
SponsorMontecatone Rehabilitation Institute S.p.A.