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

NCT05887752 | Recruiting

• 2 other identifiers: CE AVEC 286-2023-DISP-AUSLIMMRI_47-2023
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injury

Keywords

Robotic rehabilitation; Trunk control; Hunova

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Baseline (initial assessment); 2 weeks after Baseline

Secondary Outcomes (12)

• Change of trunk control after 20 versus 10 Hunova® rehab sessions

  Baseline (initial assessment); 2 weeks after Baseline; 4 weeks after Baseline

• Change of trunk equilibrium after 20 versus 10 Hunova® rehabilitation sessions

  Baseline (initial assessment); 2 weeks after Baseline; 4 weeks after Baseline

• Comparison between trunk control measurements obtained by Hunova® and a validated clinical scale

  Baseline (initial assessment); 2 weeks after Baseline; 4 weeks after Baseline

• Estimation of correlation between change of trunk control and functional activities - self care

  Baseline (initial assessment); 2 weeks after Baseline; 4 weeks after Baseline

• Estimation of correlation between change of trunk control and functional activities - overall mobility

  Baseline (initial assessment); 2 weeks after Baseline; 4 weeks after Baseline

Study Arms (2)

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.

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.

Other: Standard rehabilitation; Device: Hunova® rehabilitation

Interventions

Standard rehabilitation OTHER

Carried out 3h/day, 5 days/week at the Montecatone Institute. It implies a multiprofessional approach through: * physiotherapy; * occupational therapy; * sports rehabilitation.

Standard rehab plus 10-session, delayed, Hunova rehabilitation; Standard rehab plus 20-session Hunova rehabilitation

Hunova® rehabilitation DEVICE

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.

Standard rehab plus 10-session, delayed, Hunova rehabilitation; Standard rehab plus 20-session Hunova rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Montecatone Rehabilitation Institute S.p.A.: lead

Study Sites (1)

Montecatone Rehabilitation Institute S.p.A.

Imola, BO, 40026, Italy

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Ilaria Baroncini, MD

  Montecatone Rehabilitation Institute S.p.A.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilaria Baroncini, MD

CONTACT

+39 0542 632811; ilaria.baroncini@montecatone.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: After selection and enrollment, just before the beginning of the 4-week rehabilitation period, baseline assessments are carried out and patients are randomized. Due to the nature of the Hunova® treatment, blinding of patients and researchers involved in treatment administration will not be possible. Blinding is thus forecast for outcomes' assessors and statisticians only.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial (add-on in the first half of the study period)

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 5, 2023
• Study Start: June 5, 2023
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

IT (1)