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

Primary Purpose

Spinal Cord Injury

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Standard rehabilitation
Hunova® rehabilitation
Sponsored by
Montecatone Rehabilitation Institute S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring Robotic rehabilitation, Trunk control, Hunova

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Montecatone Rehabilitation Institute S.p.A.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Standard rehab plus 20-session Hunova rehabilitation

Standard rehab plus 10-session, delayed, Hunova rehabilitation

Arm 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.

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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
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)
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")
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");
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
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
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)
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
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
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
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

Full Information

First Posted
May 24, 2023
Last Updated
June 8, 2023
Sponsor
Montecatone Rehabilitation Institute S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT05887752
Brief Title
Hunova® Randomized Controlled Trial for Trunk Control Improvement in Spinal Cord Injured Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 5, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montecatone Rehabilitation Institute S.p.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Robotic rehabilitation, Trunk control, Hunova

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial (add-on in the first half of the study period)
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard rehab plus 20-session Hunova rehabilitation
Arm Type
Experimental
Arm 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.
Arm Title
Standard rehab plus 10-session, delayed, Hunova rehabilitation
Arm Type
Other
Arm 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.
Intervention Type
Other
Intervention Name(s)
Standard rehabilitation
Intervention Description
Carried out 3h/day, 5 days/week at the Montecatone Institute. It implies a multiprofessional approach through: physiotherapy; occupational therapy; sports rehabilitation.
Intervention Type
Device
Intervention Name(s)
Hunova® rehabilitation
Intervention Description
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 Measure Information:
Title
Change of trunk control after 10 sessions of Hunova® rehabilitation
Description
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
Time Frame
Baseline (initial assessment); 2 weeks after Baseline
Title
Change of trunk equilibrium after 10 sessions of Hunova® rehabilitation
Description
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
Time Frame
Baseline (initial assessment); 2 weeks after Baseline
Secondary Outcome Measure Information:
Title
Change of trunk control after 20 versus 10 Hunova® rehab sessions
Description
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
Time Frame
Baseline (initial assessment); 2 weeks after Baseline; 4 weeks after Baseline
Title
Change of trunk equilibrium after 20 versus 10 Hunova® rehabilitation sessions
Description
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
Time Frame
Baseline (initial assessment); 2 weeks after Baseline; 4 weeks after Baseline
Title
Comparison between trunk control measurements obtained by Hunova® and a validated clinical scale
Description
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)
Time Frame
Baseline (initial assessment); 2 weeks after Baseline; 4 weeks after Baseline
Title
Estimation of correlation between change of trunk control and functional activities - self care
Description
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")
Time Frame
Baseline (initial assessment); 2 weeks after Baseline; 4 weeks after Baseline
Title
Estimation of correlation between change of trunk control and functional activities - overall mobility
Description
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");
Time Frame
Baseline (initial assessment); 2 weeks after Baseline; 4 weeks after Baseline
Title
Estimation of correlation between change of trunk control and patients' self-perception of performances in functional activities
Description
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
Time Frame
Baseline (initial assessment); 2 weeks after Baseline; 4 weeks after Baseline
Title
Estimation of correlation between change of trunk control and patients' satisfaction with performances in functional activities
Description
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
Time Frame
Baseline (initial assessment); 2 weeks after Baseline; 4 weeks after Baseline
Title
Estimation of correlation between change of trunk control and patients' quality of life
Description
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)
Time Frame
Baseline (initial assessment); 2 weeks after Baseline; 4 weeks after Baseline
Title
Change of the COP area as a function of SCI neurologic categories
Description
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
Time Frame
Baseline (initial assessment); 2 weeks after Baseline; 4 weeks after Baseline
Title
Change of activity patterns in muscles involved in trunk control, assessed by electromyography
Description
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
Time Frame
Baseline (initial assessment); 4 weeks after Baseline
Title
Tolerability of the Hunova® rehab treatment
Description
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
Time Frame
For intervention arm: 2 weeks after Baseline; 4 weeks after Baseline. For comparator arm: 4 weeks after Baseline
Title
Satisfaction of the Hunova® rehab treatment
Description
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
Time Frame
Time Frame: 4 weeks after Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ilaria Baroncini, MD
Phone
+39 0542 632811
Email
ilaria.baroncini@montecatone.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilaria Baroncini, MD
Organizational Affiliation
Montecatone Rehabilitation Institute S.p.A.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montecatone Rehabilitation Institute S.p.A.
City
Imola
State/Province
BO
ZIP/Postal Code
40026
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilaria Baroncini
Phone
+39 0542 632811
Email
ilaria.baroncini@montecatone.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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