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

Montecatone Rehabilitation Institute S.p.A.

Status: Enrolling

Conditions: Spinal Cord Injury

Treatments: Other: Standard rehabilitation; Device: Hunova® rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT05887752

MRI_47-2023 (Other Identifier)

CE AVEC 286-2023-DISP-AUSLIM

Details and patient eligibility

About

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.

Full description

In SCI patients trunk and therefore postural control (both in statics and dynamics) are impaired, often with strong consequences on daily life activities. Postural control is defined as the ability to maintain balance despite internal and external perturbations, with the aim of bringing the person's barycenter within his standing area.

Therefore, improvement and reinforcement of trunk control are primary rehab goals.

For the evaluation of trunk control in SCI people, still today no tests and scales are definable as gold standards. Only a few are considered as more reliable, some of them suitable for acute/subacute SCI, some others for chronic SCI. In some published studies, inertial sensors have been used for a more precise evaluation of the Center of Pressure (COP), of the sway area, in relation to the trunk control, but further validation studies are needed. The use of more objective tools could provide additional information on the behavior of SCI people on postural control, thus not only on muscle strength. Of particular interest are the less or more complex compensation strategies implemented and the muscle activation patterns involved in trunk control, assessable through e.g. surface electromyography.

Nowadays, for rehab purposes of trunk control, balance and proprioception, in both sitting and standing position, conventional rehab 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 same Hunova® device also allows parameters evaluation by means of its output data.

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 rehab 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.

Randomization will be stratified, based on SCI lesion completeness. A 1:1 allocation ratio will be used for each stratum.

Enrollment: 78 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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78 participants in 2 patient groups

Standard rehab plus 20-session Hunova rehabilitation

Experimental group

Description:

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.

Treatment:

Device: Hunova® rehabilitation

Other: Standard rehabilitation

Standard rehab plus 10-session, delayed, Hunova rehabilitation

Other group

Description:

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.

Treatment:

Device: Hunova® rehabilitation

Other: Standard rehabilitation