Hunova® Randomized Controlled Trial for Trunk Control Improvement in Spinal Cord Injured Patients
Recruiting now · Not applicable
Conditions studied: Spinal Cord Injury
In brief
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.
Key facts
- Study ID
- NCT05887752
- Run by
- Montecatone Rehabilitation Institute S.p.A.
- People needed
- 78
- Starts
- 2023-06-05
- Expected to finish
- 2026-04-01
- Last updated by the study team
- 2025-09-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Montecatone Rehabilitation Institute S.p.A. — Imola, BO, Italy (enrolling)
Full record on ClinicalTrials.gov
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