Spinal Cord InjuryNCT05887752
Hunova® Randomized Controlled Trial for Trunk Control Improvement in Spinal Cord Injured Patients
A study testing Standard rehabilitation and Hunova® rehabilitation in people with Spinal Cord Injury, run by Montecatone Rehabilitation Institute S.p.A. at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Standard rehabilitation and Hunova® rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteItaly
- Study dates
- 5 Jun 2023to 5 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Spinal Cord Injury
- Being tested
- Standard rehabilitation, Hunova® rehabilitation
- Keywords
- Robotic rehabilitation, Trunk control, Hunova
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard rehabilitationOther
Carried out 3h/day, 5 days/week at the Montecatone Institute. It implies a multiprofessional approach through:
- physiotherapy;
- occupational therapy;
- sports rehabilitation.
Hunova® rehabilitationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard rehab plus 20-session Hunova rehabilitation | Experimental | 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. Receives: Other: Standard rehabilitation; Device: Hunova® rehabilitation |
| Standard rehab plus 10-session, delayed, Hunova rehabilitation | Other | 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. Receives: Other: Standard rehabilitation; Device: Hunova® rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of trunk control after 10 sessions of Hunova® rehabilitation
Evaluation of the efficacy of Hunova® rehabilitation for 10 consecutive sessions (2 weeks treatment period), in addition to the Standard rehab treatment, compared to the Standard treatment only, in terms of improvement of trunk control (both in statics and dynamics), while seated. The validated Trunk Control Test clinical measurement scale for SCI people (TCT-SCI) is employed
Measured: Baseline (initial assessment); 2 weeks after Baseline
Change of trunk equilibrium after 10 sessions of Hunova® rehabilitation
Evaluation of the efficacy of Hunova® rehabilitation for 10 consecutive sessions (2 weeks treatment period), in addition to the Standard rehab treatment, compared to the Standard treatment only, in terms of ability to adapt to external postural perturbations. The validated Trunk Control Test clinical measurement scale for SCI people (TCT-SCI) is employed
Measured: Baseline (initial assessment); 2 weeks after Baseline
Secondary outcomes (12)
Change of trunk control after 20 versus 10 Hunova® rehab sessions
Evaluation of the efficacy of Hunova® treatment for a prolonged period of 20 sessions (4 weeks), compared to a basic treatment of 10 sessions (2 weeks), in terms of improvement of trunk control (both in statics and dynamics), while seated. The validated TCT-SCI scale is employed for assessments
Measured: Baseline (initial assessment); 2 weeks after Baseline; 4 weeks after Baseline
Change of trunk equilibrium after 20 versus 10 Hunova® rehabilitation sessions
Evaluation of the efficacy of Hunova® treatment for a prolonged period of 20 sessions (4 weeks), compared to a basic treatment of 10 sessions (2 weeks), in terms of improvement of ability to adapt to postural perturbations. The validated TCT-SCI scale is employed for assessments
Measured: Baseline (initial assessment); 2 weeks after Baseline; 4 weeks after Baseline
Comparison between trunk control measurements obtained by Hunova® and a validated clinical scale
Estimation, during and after the rehabilitation period, of the correlation between measures of trunk control improvement, given by the Hunova® device itself, and operator-dependent measures obtained through a validated clinical scale (TCT-SCI)
Measured: Baseline (initial assessment); 2 weeks after Baseline; 4 weeks after Baseline
Estimation of correlation between change of trunk control and functional activities - self care
Estimation, during and after the rehabilitation period, of the correlation between improved trunk control (measured by the TCT-SCI scale) and the improvement in functional activities (measured through the Spinal Cord Independence Measure (SCIM) scale, version III, section "Self-care")
Measured: Baseline (initial assessment); 2 weeks after Baseline; 4 weeks after Baseline
Estimation of correlation between change of trunk control and functional activities - overall mobility
Estimation, during and after the rehabilitation period, of the correlation between improved trunk control (measured by the TCT-SCI scale) and the improvement in functional activities (measured by a physician through the Spinal Cord Independence Measure (SCIM) scale, version III, section "Overall mobility");
Measured: 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
Estimation, during and after the rehabilitation period, of the correlation between the change of trunk control (measured by the TCT scale) and the change of patient's self-perception of the performance (measured by the Canadian Occupational Performance Measure questionnaire - COPM) of those functional activities self-perceived as relevant
Measured: 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
Estimation, during and after the rehabilitation period, of the correlation between the change of trunk control (measured by the TCT scale) and the change of patients' satisfaction with the performance (measured by the Canadian Occupational Performance Measure questionnaire - COPM) of those functional activities self-perceived as relevant
Measured: Baseline (initial assessment); 2 weeks after Baseline; 4 weeks after Baseline
Estimation of correlation between change of trunk control and patients' quality of life
Estimation, during and after the rehabilitation period, of the correlation between the change of trunk control (measured by the TCT scale) and the change of quality of life perceived by the study subjects (measured by the questionnaire developed by the World Health Organization of the Quality of Life assessment, shorter version - WHOQOL-BREF)
Measured: Baseline (initial assessment); 2 weeks after Baseline; 4 weeks after Baseline
Change of the COP area as a function of SCI neurologic categories
Analysis of the variation of the Centre Of Pressure (COP) area during and after the rehabilitation period, stratified by the following SCI categories: complete paraplegia with high thoracic SCI (neurological level ≥T6), complete paraplegia with low thoracic SCI (neurological level <T6), incomplete paraplegia and tetraplegia. Measurements will be carried out in centimeters
Measured: Baseline (initial assessment); 2 weeks after Baseline; 4 weeks after Baseline
Change of activity patterns in muscles involved in trunk control, assessed by electromyography
Evaluation of the variation of muscle activity patterns of the muscles contributing to the maintaining of trunk control (latissimus dorsi, trapezius, latissimus pectoralis, erector spinae), between the beginning and the end of the 4-week rehab period under study. Measurements will be carried out through surface dynamic electromyography
Measured: Baseline (initial assessment); 4 weeks after Baseline
Tolerability of the Hunova® rehab treatment
Self-patient's perception of the fatigue during the treatment with Hunova®, associated with the Standard rehabilitation treatment, for trunk control. Assessments are carried out through an in-house developed, self-administered questionnaire at the end of the 4-week rehab period under study
Measured: For intervention arm: 2 weeks after Baseline; 4 weeks after Baseline. For comparator arm: 4 weeks after Baseline
Satisfaction of the Hunova® rehab treatment
Patient's satisfaction with the Hunova® treatment associated with the Standard rehabilitation treatment for trunk control. Assessments are carried out through an in-house developed questionnaire, administered by a physiotherapist, at the end of the 4-week rehab period under study
Measured: Time Frame: 4 weeks after Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start5 Jun 2023
- Primary completion5 Apr 2026
- Study completion5 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial (add-on in the first half of the study period)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montecatone Rehabilitation Institute S.p.A.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ilaria Baroncini, MD, Principal investigator, Montecatone Rehabilitation Institute S.p.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887752
- Sponsor's protocol ID
- CE AVEC 286-2023-DISP-AUSLIM
- Other IDs
- MRI_47-2023
- Status last verified
- Aug 2026
- First submitted
- 24 May 2023
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05887752
- Acronym / sponsor ID
- CE AVEC 286-2023-DISP-AUSLIM
- Conditions
- Spinal Cord Injury
- Keywords
- Robotic rehabilitation, Trunk control, Hunova
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Montecatone Rehabilitation Institute S.p.A.University, hospital or other
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 5 Apr 2026 (actual)
- Study completion
- 5 May 2026 (actual)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial (add-on in the first half of the study period)
| Arm | Type | Receives |
|---|---|---|
| Standard rehab plus 20-session Hunova rehabilitation | Experimental | Other: Standard rehabilitation, Device: Hunova® rehabilitationPatients 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. |
| Standard rehab plus 10-session, delayed, Hunova rehabilitation | Other | Other: Standard rehabilitation, Device: Hunova® rehabilitationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard rehabilitationCarried out 3h/day, 5 days/week at the Montecatone Institute. It implies a multiprofessional approach through: * physiotherapy; * occupational therapy; * sports rehabilitation. | Other | Standard rehab plus 10-session, delayed, Hunova rehabilitation, Standard rehab plus 20-session Hunova rehabilitation |
| Hunova® rehabilitationPerformed 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. | Device | Standard rehab plus 10-session, delayed, Hunova rehabilitation, Standard rehab plus 20-session Hunova rehabilitation |
Primary outcome
Change of trunk control after 10 sessions of Hunova® rehabilitation
Time frame: Baseline (initial assessment); 2 weeks after Baseline
Evaluation of the efficacy of Hunova® rehabilitation for 10 consecutive sessions (2 weeks treatment period), in addition to the Standard rehab treatment, compared to the Standard treatment only, in terms of improvement of trunk control (both in statics and dynamics), while seated. The validated Trunk Control Test clinical measurement scale for SCI people (TCT-SCI) is employed
Change of trunk equilibrium after 10 sessions of Hunova® rehabilitation
Time frame: Baseline (initial assessment); 2 weeks after Baseline
Evaluation of the efficacy of Hunova® rehabilitation for 10 consecutive sessions (2 weeks treatment period), in addition to the Standard rehab treatment, compared to the Standard treatment only, in terms of ability to adapt to external postural perturbations. The validated Trunk Control Test clinical measurement scale for SCI people (TCT-SCI) is employed
12 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilaria Baroncini, MD principal investigator
Montecatone Rehabilitation Institute S.p.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard rehabilitation and Hunova® rehabilitation in people with Spinal Cord Injury, run by Montecatone Rehabilitation Institute S.p.A. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of trunk control after 10 sessions of Hunova® rehabilitation (time frame: Baseline (initial assessment); 2 weeks after Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.