Proof of Concept of Hybrid Robotics for Gait Rehabilitation of Persons Post-stroke

Browse trials for

• Gait Disorders, Neurologic 339
• Hemiplegia 390

Keywords

• Gait rehabilitation
• Exoskeleton
• Functional Electrical Stimulation
• Hemiplegia
• Overground

Gait Disorders, Neurologic

339 studies on the registry are indexed under Gait Disorders, Neurologic; 55 are open to participants now.

This study's planned enrollment of 70 is above the median of 30 across 255 interventional studies indexed under Gait Disorders, Neurologic.

Lead sponsor

Fondazione Don Carlo Gnocchi ETS is the lead sponsor of 41 studies on the registry; 25 are open to participants now.

Study arms

• Experimental
  Exoskeleton plus FES

  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.

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

• Active comparator
  Exoskeleton

  Participants will train gait with an overground exoskeleton.

  Device: Overground gait exoskeleton

Interventions

• DeviceCombined overground gait exoskeleton and FES applied to lower limb

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

  Also known as: TWIN_Acta and FITFES

• DeviceOverground gait exoskeleton

  Gait rehabilitation for persons with stroke, with an overground exoskeleton.

  Also known as: TWIN_Acta

Primary outcomes

1. System Usability scale (SUS)

   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.

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

2. Velocity of gait

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

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

Secondary outcomes

1. Motricity Index Lower limb (MI LL)

   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.

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

2. Fugl Meyer Assessment of motor recovery after stroke. Lower limb (FMA LL)

   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.

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

3. Functional Ambulation Category (FAC)

   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.

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

4. Stroke Rehabilitation Motivation Scale (7-item SRMS)

   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.

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

5. Fatigue Severity Scale (FSS)

   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.

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

6. Ashworth scale

   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

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

7. Manual muscle test (MMT)

   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.

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

8. Five times sit to stand test (5TStS)

   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.

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

9. Timed up and go test (TUG)

   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.

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

10. Two minutes walking test (2MWT)

    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

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

11. 10 meter walking test (10MVT)

    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.

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

12. The walking handicap scale (WHS)

    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.

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

13. Beck Depression Inventory-II (BDI-II)

    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.

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

14. Unified Theory of Acceptance and Use of Technology (UTAUT)

    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.

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

15. Report of adverse events

    Organized reporting of adverse events occurring during the use of the device

    Time frame: at baseline and at post after 4 weeks of intervention

16. Euro Quality of Life-5 -dimension Questionnaire (EQ-5D-5L)

    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.

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

17. Motion parameters derived from the kinematics of the body

    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.

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

18. Postural capabilities will be evaluated based on body kinetics

    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.

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

19. Muscular synergies

    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.

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

20. Instrumented 2 Minute Walk test (I2MWT)

    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.

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

21. Instrumented Timed Up and Go (ITUG)

    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.

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

Individual participant data

Plan to share: Yes — Data will be available upon request

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

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

Access criteria: at request to the Principal investigator