Hunova® Randomized Controlled Trial for Trunk Control Improvement in Spinal Cord Injured Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard rehabilitation, Hunova® rehabilitation.
- Who it may be relevant to
- Registry conditions: Spinal Cord Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed 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.
Interventions
- Other Standard rehabilitation
Carried out 3h/day, 5 days/week at the Montecatone Institute. It implies a multiprofessional approach through: * physiotherapy; * occupational therapy; * sports rehabilitation. - Device Hunova® rehabilitation
Performed in a dedicated gym of the Montecatone Institute, 1 hour/day, 5 days/week, in the presence of a physiotherapist. Depending on the improvement of the person and of his skills acquisition, the degree of tilting of the Hunova® seat in the various planes may vary.
Primary outcome measures
- Change of trunk control after 10 sessions of Hunova® rehabilitation [Time frame: Baseline (initial assessment); 2 weeks after Baseline]
- Change of trunk equilibrium after 10 sessions of Hunova® rehabilitation [Time frame: Baseline (initial assessment); 2 weeks after Baseline]
Secondary outcome measures (12)
- Change of trunk control after 20 versus 10 Hunova® rehab sessions [Time frame: Baseline (initial assessment); 2 weeks after Baseline; 4 weeks after Baseline]
- Change of trunk equilibrium after 20 versus 10 Hunova® rehabilitation sessions [Time frame: Baseline (initial assessment); 2 weeks after Baseline; 4 weeks after Baseline]
- Comparison between trunk control measurements obtained by Hunova® and a validated clinical scale [Time frame: Baseline (initial assessment); 2 weeks after Baseline; 4 weeks after Baseline]
- Estimation of correlation between change of trunk control and functional activities - self care [Time frame: Baseline (initial assessment); 2 weeks after Baseline; 4 weeks after Baseline]
- Estimation of correlation between change of trunk control and functional activities - overall mobility [Time frame: Baseline (initial assessment); 2 weeks after Baseline; 4 weeks after Baseline]
- Estimation of correlation between change of trunk control and patients' self-perception of performances in functional activities [Time frame: Baseline (initial assessment); 2 weeks after Baseline; 4 weeks after Baseline]
- Estimation of correlation between change of trunk control and patients' satisfaction with performances in functional activities [Time frame: Baseline (initial assessment); 2 weeks after Baseline; 4 weeks after Baseline]
- Estimation of correlation between change of trunk control and patients' quality of life [Time frame: Baseline (initial assessment); 2 weeks after Baseline; 4 weeks after Baseline]
- Change of the COP area as a function of SCI neurologic categories [Time frame: Baseline (initial assessment); 2 weeks after Baseline; 4 weeks after Baseline]
- Change of activity patterns in muscles involved in trunk control, assessed by electromyography [Time frame: Baseline (initial assessment); 4 weeks after Baseline]
- Tolerability of the Hunova® rehab treatment [Time frame: For intervention arm: 2 weeks after Baseline; 4 weeks after Baseline. For comparator arm: 4 weeks after Baseline]
- Satisfaction of the Hunova® rehab treatment [Time frame: Time Frame: 4 weeks after Baseline]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Montecatone Rehabilitation Institute S.p.A. — Imola
Identifiers
NCT: NCT05887752 · CE AVEC 286-2023-DISP-AUSLIM · MRI_47-2023