## Protocol Section
### Identification Module
**NCT ID:** NCT06436898

**Acronym:** PoCH-Rehab

**Brief Title:** Proof of Concept of Hybrid Robotics for Gait Rehabilitation of Persons Post-stroke

**Official Title:** Proof of Concept of Hybrid Robotics for Gait Rehabilitation of Persons Post-stroke (PoCH-Rehab)

#### Organization Study ID Info
**ID:** PoCH-Rehab
#### Organization
**Class:** OTHER
**Full Name:** Fondazione Don Carlo Gnocchi Onlus
### Status Module
#### Completion Date
**Date:** 2025-11-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-24

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-07-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-09-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-02-16
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Istituto Italiano di Tecnologia

**Class:** OTHER

**Name:** Istituto Nazionale di Ricovero e Cura per Anziani

#### Lead Sponsor

**Class:** OTHER

**Name:** Fondazione Don Carlo Gnocchi Onlus

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Persons post-stroke suffer from hemiparesis affecting the functional abilities of the controlesional lower limb. Improving walking is therefore a primary rehabilitation goal for such patients. Robotic-Assisted Rehabilitation (RAR, e.g. exoskeletons) and Functional Electrical Stimulation (FES) are promising techniques to facilitate the functional recovery after stroke. allowing benefits to be maintained over long term.

**Detailed Description:** Exoskeletons were originally developed for subjects with spinal cord injury where they demonstrated a positive impact on rehabilitation and relative costs. The investigators expect the same trend also for stroke. Based on prior exploratory activities using an overgorund exoskeleton (TWIN_Acta) in gait rehabilitation post stroke, in this project the aim is to merge the potential of an overground exoskeleton and FES to treat the lower limb motor deficits in persons post-stroke, strengthening their residual abilities. Synchronized pairing of the two devices might boost the functional recovery of gait post-stroke by promoting neural reorganization The persons post stroke will undergo 20 gait rehabiliation sessions with the exoskeleton and with FES applied to the lower limb muscles during execution of gait with the aim of improving various gait and quality of life parameters. This experimental intervention will be compared to a control intervention using an exoskeleton alone for gait rehabiltation post stroke.

### Conditions Module

**Conditions:**

- Stroke Sequelae

- Gait, Hemiplegic

**Keywords:**

- Gait rehabilitation

- Exoskeleton

- Functional Electrical Stimulation

- Hemiplegia

- Overground

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Masking Description:** Assessor blind to treatment arm

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 70

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will train gait with an overground exoskeleton and a combined myoelectrically controlled Functional Electrostimulation System (FES) applied to lower limb muscles during execution of gait.

**Intervention Names:**

- Device: Combined overground gait exoskeleton and FES applied to lower limb

**Label:** Exoskeleton plus FES

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants will train gait with an overground exoskeleton.

**Intervention Names:**

- Device: Overground gait exoskeleton

**Label:** Exoskeleton

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Exoskeleton plus FES

**Description:** Gait rehabilitation for persons with stroke, with an overground exoskeleton combined with an electromyographically controlled FES applied to lower limb muscles during gait.

**Name:** Combined overground gait exoskeleton and FES applied to lower limb

**Other Names:**

- TWIN_Acta and FITFES

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Exoskeleton

**Description:** Gait rehabilitation for persons with stroke, with an overground exoskeleton.

**Name:** Overground gait exoskeleton

**Other Names:**

- TWIN_Acta

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** The SUS assesses Usability and Acceptability of a device. The SUS consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. The scores will be normalized to produce a percentile ranking. The higher the percentage the better the tested device is considiered.

**Measure:** System Usability scale (SUS)

**Time Frame:** At baseline and at post after 4 weeks of intervention

**Description:** Gait velocity during 3D gait analysis measured while walking overground over 10 meters. Velocity is measured in meters/second

**Measure:** Velocity of gait

**Time Frame:** At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention

#### Secondary Outcomes

**Description:** The motricity index is an ordinal method fo measuring limb strength. Maximum total lower limb score is 99. Scoring goes from 0 no movement to 33 normal power.

**Measure:** Motricity Index Lower limb (MI LL)

**Time Frame:** At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention

**Description:** The scale evaluates and measures neuromotor recovery in post stroke patients. Items are scored on a 3-point ordinal scale, from 0 cannot perform to score 2 performs fully. Maximum score for lower limb is 34.

**Measure:** Fugl Meyer Assessment of motor recovery after stroke. Lower limb (FMA LL)

**Time Frame:** At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention

**Description:** The FAC assesses functional ambulation in patients undergoing physical therapy. The clinician ticks a box of 5 broad categories of walking ability from not being able to walk or needing help from to or more persons to score of 5 if they can walk independently anywhere.

**Measure:** Functional Ambulation Category (FAC)

**Time Frame:** At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention

**Description:** The 7-item SRMS was devised from the 28-item SRMS and inquires upon intrinsic and extrinsic motivation domains for rehabilitation. Scores range from 1 to 7 so the total score can range from 7-35 with higher scores indicating higher motivation.

**Measure:** Stroke Rehabilitation Motivation Scale (7-item SRMS)

**Time Frame:** At baseline and at post after 4 weeks of intervention

**Description:** The impact of fatigue on day-to-day function is measured using the Fatigue Severity Scale (FSS). This measure is a self-report scale with nine questions answered on a 7-point Likert scale. The FSS score is reported as one total score which is the mean of the nine items. Scores range from 1 to 7 and higher scores indicate greater impact of fatigue on daily life.

**Measure:** Fatigue Severity Scale (FSS)

**Time Frame:** At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention

**Description:** The Modified Ashworth Scale (MAS) is a revised version of the original Ashworth Scale that measures spasticity in patients with lesions to the central nervous system. MAS is an assessment that is used to measure the increase in muscle tone. MAS assigns a grade of spasticity from a 0-4 ordinal scale with higher score indicating more spasticity. The grade is assigned by moving a joint/muscle through a high velocity quick stretch.Spasticity of calf and knee muscles will be tested

**Measure:** Ashworth scale

**Time Frame:** At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention

**Description:** MMT is a standardized set of assessments that measure muscle strength and function. Score range 0-5, minimum 0, maximum 5/5 meaning normal strength. Strength of calf and knee muscles will be tested.

**Measure:** Manual muscle test (MMT)

**Time Frame:** At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention

**Description:** The Five Times Sit to Stand Test measures one aspect of transfer skill. The test provides a method to quantify functional lower extremity strength and/or identify movement strategies a patient uses to complete transitional movements. Patient is timed while standing up and sitting down 5 times in row.

**Measure:** Five times sit to stand test (5TStS)

**Time Frame:** At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention

**Description:** The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk. Patient are timed while standing up from a chair walking 3 meters, turning around, walking 3 meters and sitting down again.

The patient sits in the chair with his/her back against the chair back. On the command "go," the patient rises from the chair, walks 3 meters at a comfortable and safe pace, turns, walks back to the chair and sits down.

Timing begins at the instruction "go" and stops when the patient is seated.

**Measure:** Timed up and go test (TUG)

**Time Frame:** At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention

**Description:** Walking capcaity is measured with the Participant timed while walking a 30 meter track constantly for 2 minutes. Participants are permitted to use their walking aids if necessary. The distance walked in 2 minutes is recorded and reported in metres

**Measure:** Two minutes walking test (2MWT)

**Time Frame:** At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention

**Description:** Walking speed is measured by the timed 10 m Walk Test (10MWT). Participants walk a distance of 10 m at their usual speed with their usual walking aids. Participants are timed while walking 10 meters from a starting point to an end point. Time taken from meter 2 to meter 8. Two repetitions are completed and the average time is used to calcualte walking speed in metres/second.

**Measure:** 10 meter walking test (10MVT)

**Time Frame:** At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention

**Description:** The walking handicap scale is a questionnaire asking subjective gait skills. The scale goes from 1 to 6, with score 1 being a physiological gait only with a physiotherapist, to score 6 being unrestricted community ambulation gait.

**Measure:** The walking handicap scale (WHS)

**Time Frame:** At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention

**Description:** the BDI-II is a patient reported outcome that quantifies severity of depression. BDI-II identifies overt behavioral characteristics of depression. Items are on a four-point scale that ranges from 0 to 3. Ratings are summed to provide a total score ranging from 0 - 63. Scores \>10 generally meet the threshold for a diagnosis of depression.

**Measure:** Beck Depression Inventory-II (BDI-II)

**Time Frame:** At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention

**Description:** A questionnaire asking how acceptable and easy to use the technological device is. The theoretical model of UTAUT suggests that the actual use of technology is determined by behavioural intention. The perceived likelihood of adopting the technology is dependent on the direct effect of four key constructs, namely performance expectancy, effort expectancy, social influence, and facilitating conditions. The UTAUT examines the acceptance of technology, determined by the effects of performance expectancy, effort expectancy, social influence and facilitating conditions.

**Measure:** Unified Theory of Acceptance and Use of Technology (UTAUT)

**Time Frame:** At baseline and at post after 4 weeks of intervention

**Description:** Organized reporting of adverse events occurring during the use of the device

**Measure:** Report of adverse events

**Time Frame:** at baseline and at post after 4 weeks of intervention

**Description:** EQ-5D-FL is a standardized instrument for use as a measure of health for clinical and economic appraisal.Applicable to a wide range of health conditions and treatments, the EQ-5D health questionnaire provides a simple descriptive profile and a single index value for health status.

Measures the 5 dimensions of:

1. mobility
2. self-care
3. usual activities
4. pain/discomfort
5. anxiety/depression Each dimension is scored on a Likert scale of 5 levels, with higher scores indicating more severe problems.

**Measure:** Euro Quality of Life-5 -dimension Questionnaire (EQ-5D-5L)

**Time Frame:** At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention

**Description:** Lower limb data will be captured utilizing two wearable Inertia Measurement Units (IMUs) operating at 280 Hz. These IMUs will be placed on both feet to analyze spatio-temporal gait characteristics. Through data processing, deviations from typical movement patterns will be quantified.

**Measure:** Motion parameters derived from the kinematics of the body

**Time Frame:** At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention

**Description:** Postural data of the lower limb will be acquired using an optoelectronic system combined with two force plates, sampling at 2000 Hz. Utilizing data processing techniques, deviations from normal postural dynamics will be determined.

**Measure:** Postural capabilities will be evaluated based on body kinetics

**Time Frame:** At baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention

**Description:** Muscle synergies will be extracted from the Electromyography (EMG) envelope of each participant detected during overground gait employing the Non-Negative Matrix Factorization algorithm. Treatment-induced changes in the resemblance of muscle synergies to physiological patterns will be assessed. Module similarity will be gauged through the maximum scalar product of muscle weightings between each participant and the normative reference. Additionally, the activation profile similarity will be measured using the Pearson's correlation coefficient of each module's activation profile.

**Measure:** Muscular synergies

**Time Frame:** at baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention

**Description:** Changes in the I2MWT will be evaluated through IMU sampling at 280 Hz positioned on the lower back. Deviations from the typical performance observed in healthy subjects will be evaluated.

**Measure:** Instrumented 2 Minute Walk test (I2MWT)

**Time Frame:** at baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention

**Description:** Changes in the instrumented Timed Up and Go (ITUG) test will be examined. The TUG test will be administered with an IMU sampling at 280 Hz positioned on the lower back. Deviations from the typical performance observed in healthy subjects will be evaluated.

**Measure:** Instrumented Timed Up and Go (ITUG)

**Time Frame:** at baseline, at post after 4 weeks of intervention, at follow up after 8 weeks from the end of intervention

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

18 years or older

* Diagnosis of first unilateral ischemic or hemorrhagic ictus, at least two weeks from the event, ischemic or hemorrhagic
* diagnosis confermed with Computer Tomography or Magnetic Resonance Imaging
* 1 ≤ FAC (Functional ambulation category) ≤ 3
* 50 kg ≤ weight ≤ 90 kg
* 150 cm ≤ height ≤ 192 cm
* Femor length: 355-475 mm
* Tibia length: 405-485 mm
* Pelvic width 690-990 mm
* shoe size 36-45
* Capable of standing unsupported for at least one minute

Exclusion Criteria:

* Mini Mental State Examination score (corrected for age and education) \< 24
* Clinical evidence in the medical records of visuospatial and ideomotor apraxia, behavioral disorders, neglect, severe visual and auditory sensory disorders or those which prevent use of the device
* patients at risk of fractures or with strategic fractures (unstabilized fractures or spinal instability)
* Major head trauma
* Subarachnoid hemorrhage, cerebral thrombosis
* Cardio-respiratory or internal clinical instability
* Pregnant or breastfeeding status;
* Recent malignant neoplasm
* Chronic inflammatory diseases with joint involvement of the lower limbs;
* Severe spasticity (Ashworth\>3)
* Significant limitations in passive ROM of the hips and knees
* Problems with the integrity of the skin at the interface surfaces with the device or which would prevent sitting.
* Implanted electronic devices
* Epilepsy
* Severe peripheral neuropathies

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** tlencioni@dongnocchi.it

**Name:** Tiziana Lencioni, PhD

**Phone:** 024030

**Phone Ext:** 8547

**Role:** CONTACT

**Contact 2:**

**Email:** jjonsdottir@dongnocchi.it

**Name:** Johanna Jonsdottir, PhD

**Phone:** 024030

**Phone Ext:** 8840

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Milan

**Country:** Italy

**Facility:** Fondazione Don Carlo Gnocchi IRCCS

**Zip:** 20148

#### Overall Officials

**Official 1:**

**Affiliation:** Research Head of Biomedical Technology Department

**Name:** Maurizio Ferrarin, PhD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Research Head of the Neurological Unit

**Name:** Andrea Corsonello, PhD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Access Criteria:** at request to the Principal investigator

**Description:** Data will be available upon request

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

**IPD Sharing:** YES

**Time Frame:** Preliminary data will be available at the end of the study February 2025

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002561

- Term: Cerebrovascular Disorders

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M22306

- Name: Stroke

- Relevance: HIGH

- As Found: Stroke

- ID: M9515

- Name: Hemiplegia

- Relevance: LOW

- As Found: Unknown

- ID: M22058

- Name: Gait Disorders, Neurologic

- Relevance: HIGH

- As Found: Gait, Hemiplegic

- ID: M5810

- Name: Cerebrovascular Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000020521

- Term: Stroke

- ID: D000020233

- Term: Gait Disorders, Neurologic

### Misc Info Module

- Version Holder: 2024-05-31
