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

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Montecatone Rehabilitation Institute S.p.A.
RECRUITING
Imola
Contact Information
Primary
Ilaria Baroncini, MD
ilaria.baroncini@montecatone.com
+39 0542 632811
Time Frame
Start Date: 2023-06-05
Estimated Completion Date: 2026-04
Participants
Target number of participants: 78
Treatments
Experimental: Standard rehab plus 20-session Hunova rehabilitation
Patients will receive the Standard rehabilitation for a period of 4 weeks.~In the same 4 weeks and days, the Hunova® rehabilitation (20 sessions in total) will also be administered.
Other: Standard rehab plus 10-session, delayed, Hunova rehabilitation
Patients will receive the Standard rehabilitation for a period of 4 weeks.~During the last 2 weeks, in the same days, the Hunova® rehabilitation (10 sessions in total) will be also administered.
Related Therapeutic Areas
Sponsors
Leads: Montecatone Rehabilitation Institute S.p.A.

This content was sourced from clinicaltrials.gov