search
Back to results

Upper Limb Task-Oriented Rehabilitation With Robotic Exoskeleton for Hemiparetic Stroke Patients (RH-LEXOS)

Primary Purpose

Cerebrovascular Accident (CVA), Chronic Disease, Stroke Rehabilitation

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Upper Arm Rehabilitation Light Exoskeleton (RH-LEXOS)
Sponsored by
Scuola Superiore Sant'Anna di Pisa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Accident (CVA) focused on measuring Robotics [H01.671.293.643], Exoskeleton Device [E07.341], Rehabilitation Research [H01.770.644.145.472], Physical and Rehabilitation Medicine [H02.403.680], Exercise Therapy [E02.779.483], Patient Outcome Assessment [N05.715.360.575.575.399]

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis of a first-ever left hemisphere ischemic or hemorrhagic stroke at least 6 months prior to entry into the study;
  • minimum ability for shoulder humeral elevation;
  • upper-extremity motor function Fugl-Meyer (FM) score ≥ 15(out of 66);
  • absence of neurological or muscular disorders that interfere with neuromuscular function;
  • absence of severe cognitive deficits that would limit patients' ability to complete the study;
  • minimum score of 2 in the Modified Ashworth Scale;
  • not participating in any experimental rehabilitation or drug studies at the same time
  • no previous experience with robotic treatments.

Sites / Locations

  • University Hospital of Pisa

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Conventional treatment

Robotic treatment

Arm Description

The conventional treatment arm was conducted according to a set of exercises that were specifically designed in order to match the robotic treatment. Patients received both physical therapy (PT) and occupational therapy (OT) session, administered by the physiotherapists of the hospital. The therapist will provide a specific conventional treatment comparable with the robotic treatment in terms of session time and therapeutic goals.

The patients enrolled in the robotic arm are going to be undergone a series of passive, assisted and active mobilization in upper limb task-oriented exercises implemented in 3d virtual environments. Briefly speaking, these tasks promote the upper arm multi-joints coordination during the execution of reaching movements and grasping actions of fixed virtual objects displaced in the space.

Outcomes

Primary Outcome Measures

Change in Fugl-Meyer Assessment (FMA( Score
The null hypothesis tested in this study was the change in motor function domain of the upper extremity portion of the Fugl-Meyer assessment in the Robotic Group (Robotic Treatment) would be the same as the one obtained by the Control Group (Conventional Treatment). The FMA outcome is further divided and analyzed in terms of sub-items. In particular, the motor FMA score is divided into proximal (shoulder and elbow movement, 36 points) and distal (hand and wrist movement, 24 points) sub-items.

Secondary Outcome Measures

Functional scale: Bimanual Activity Test (BAT)
The BAT is a functional scale designed to quantify the contribution of patient's affected upper limb to execute 25 common Activities of Daily Living such as Loosen and tighten the cap of a bottle , or unscrew a bolt. The elapsed time for accomplishing each task is measured and the therapist also give a score (ranging from 1 to 4) about the quality of each movement. The BAT data is analyzed also in terms of sub-items, divided into pinch-tasks and power-tasks collecting those items requiring fine and gross manipulation motor skills respectively.
Modified Ashworth (MA) scale
The MA scale (Bohannon and Smith, 1987) is used to evaluate spasticity of the upper limb and to assess abnormal muscle tone at the shoulder and elbow. The MA scale is a 6-point scale: scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity or increased resistance to passive movement. MA scores were averaged across the two joints and across testing directions (flexion, extension) to estimate abnormal muscle tone in the upper extremity (Zackowski, Dromerick et al., 2004)
Robotic kinesiological assessment of movement: Execution Time
This measure is evaluated only in the group of patients performing robotic training, at the end of each session through the analysis of their performance during the execution of an evaluation exercise without robotic assistance.The patients are instructed to reach different targets positioned in front of them and placed around a vertical circumference at 12 equally spaced locations. The robotic measure is extracted for each outgoing (from the center to the target) movement. The execution time is measured as the elapsed time (measure in seconds) for accomplishing each movement, measured from the time of grasping of the virtual object at the start position to the release time at the target position.
Robotic kinesiological assessment of movement: Smoothness index
This measure is evaluated only in the group of patients performing robotic training, at the end of each session through the analysis of their performance during the execution of an evaluation exercise without robotic assistance.The patients are instructed to reach different targets positioned in front of them and placed around a vertical circumference at 12 equally spaced locations. The robotic measure is extracted for each outgoing (from the center to the target) movement. The smoothness index is computed in the same interval period by counting the number of peaks in the velocity profile of movement, namely the Number of Movements Units (NMU) (Fasoli S, Krebs J Neurosci 2002)

Full Information

First Posted
October 20, 2017
Last Updated
April 8, 2021
Sponsor
Scuola Superiore Sant'Anna di Pisa
Collaborators
Azienda Ospedaliero, Universitaria Pisana
search

1. Study Identification

Unique Protocol Identification Number
NCT03319992
Brief Title
Upper Limb Task-Oriented Rehabilitation With Robotic Exoskeleton for Hemiparetic Stroke Patients
Acronym
RH-LEXOS
Official Title
Robotic Assisted Task-Oriented Rehabilitation of Upper Limb for Chronic Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
July 20, 2016 (Actual)
Primary Completion Date
October 20, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Scuola Superiore Sant'Anna di Pisa
Collaborators
Azienda Ospedaliero, Universitaria Pisana

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
The aim of this study is to evaluate the effects of an assisted rehabilitation treatment through a robotic exoskeleton device on the functional recovery in a group of patients with hemiparesis from lesion of the first motor neuron (post-stroke), compared with a group of patients subjected to a conventional rehabilitation treatment. The patients enrolled in the study are chronic stroke injured with right hemiparesis of moderate to severe degree, by the system injury pyramid, never undergoing rehabilitation treatment with robots.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident (CVA), Chronic Disease, Stroke Rehabilitation
Keywords
Robotics [H01.671.293.643], Exoskeleton Device [E07.341], Rehabilitation Research [H01.770.644.145.472], Physical and Rehabilitation Medicine [H02.403.680], Exercise Therapy [E02.779.483], Patient Outcome Assessment [N05.715.360.575.575.399]

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional treatment
Arm Type
No Intervention
Arm Description
The conventional treatment arm was conducted according to a set of exercises that were specifically designed in order to match the robotic treatment. Patients received both physical therapy (PT) and occupational therapy (OT) session, administered by the physiotherapists of the hospital. The therapist will provide a specific conventional treatment comparable with the robotic treatment in terms of session time and therapeutic goals.
Arm Title
Robotic treatment
Arm Type
Experimental
Arm Description
The patients enrolled in the robotic arm are going to be undergone a series of passive, assisted and active mobilization in upper limb task-oriented exercises implemented in 3d virtual environments. Briefly speaking, these tasks promote the upper arm multi-joints coordination during the execution of reaching movements and grasping actions of fixed virtual objects displaced in the space.
Intervention Type
Device
Intervention Name(s)
Upper Arm Rehabilitation Light Exoskeleton (RH-LEXOS)
Intervention Description
RH-LEXOS is a robotic exoskeleton device to support the rehabilitation of stroke patients. This system is conceived for the force assistance, integrated in a Virtual Reality system that allows implementing rehabilitative exercises highly interactive and engaging for the patients. Passive, assisted and active mobilization of upper arm is provided through the use of the exoskeleton robotic device within high intensive, repetitive, task-oriented exercises and an objective and reliable mean for monitoring patients' progress.
Primary Outcome Measure Information:
Title
Change in Fugl-Meyer Assessment (FMA( Score
Description
The null hypothesis tested in this study was the change in motor function domain of the upper extremity portion of the Fugl-Meyer assessment in the Robotic Group (Robotic Treatment) would be the same as the one obtained by the Control Group (Conventional Treatment). The FMA outcome is further divided and analyzed in terms of sub-items. In particular, the motor FMA score is divided into proximal (shoulder and elbow movement, 36 points) and distal (hand and wrist movement, 24 points) sub-items.
Time Frame
baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Functional scale: Bimanual Activity Test (BAT)
Description
The BAT is a functional scale designed to quantify the contribution of patient's affected upper limb to execute 25 common Activities of Daily Living such as Loosen and tighten the cap of a bottle , or unscrew a bolt. The elapsed time for accomplishing each task is measured and the therapist also give a score (ranging from 1 to 4) about the quality of each movement. The BAT data is analyzed also in terms of sub-items, divided into pinch-tasks and power-tasks collecting those items requiring fine and gross manipulation motor skills respectively.
Time Frame
baseline and 6 weeks
Title
Modified Ashworth (MA) scale
Description
The MA scale (Bohannon and Smith, 1987) is used to evaluate spasticity of the upper limb and to assess abnormal muscle tone at the shoulder and elbow. The MA scale is a 6-point scale: scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity or increased resistance to passive movement. MA scores were averaged across the two joints and across testing directions (flexion, extension) to estimate abnormal muscle tone in the upper extremity (Zackowski, Dromerick et al., 2004)
Time Frame
baseline and 6 weeks
Title
Robotic kinesiological assessment of movement: Execution Time
Description
This measure is evaluated only in the group of patients performing robotic training, at the end of each session through the analysis of their performance during the execution of an evaluation exercise without robotic assistance.The patients are instructed to reach different targets positioned in front of them and placed around a vertical circumference at 12 equally spaced locations. The robotic measure is extracted for each outgoing (from the center to the target) movement. The execution time is measured as the elapsed time (measure in seconds) for accomplishing each movement, measured from the time of grasping of the virtual object at the start position to the release time at the target position.
Time Frame
At end of each session, during 6 weeks of enrollment in treatment
Title
Robotic kinesiological assessment of movement: Smoothness index
Description
This measure is evaluated only in the group of patients performing robotic training, at the end of each session through the analysis of their performance during the execution of an evaluation exercise without robotic assistance.The patients are instructed to reach different targets positioned in front of them and placed around a vertical circumference at 12 equally spaced locations. The robotic measure is extracted for each outgoing (from the center to the target) movement. The smoothness index is computed in the same interval period by counting the number of peaks in the velocity profile of movement, namely the Number of Movements Units (NMU) (Fasoli S, Krebs J Neurosci 2002)
Time Frame
At end of each session, during 6 weeks of enrollment in treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of a first-ever left hemisphere ischemic or hemorrhagic stroke at least 6 months prior to entry into the study; minimum ability for shoulder humeral elevation; upper-extremity motor function Fugl-Meyer (FM) score ≥ 15(out of 66); absence of neurological or muscular disorders that interfere with neuromuscular function; absence of severe cognitive deficits that would limit patients' ability to complete the study; minimum score of 2 in the Modified Ashworth Scale; not participating in any experimental rehabilitation or drug studies at the same time no previous experience with robotic treatments.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmelo Carmelo, Carmelo
Organizational Affiliation
U.O. Neurorehabilitation Division, Azienda Ospedaliero-Universitaria Pisana (AOUP)
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital of Pisa
City
Pisa
ZIP/Postal Code
56123
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
De-identified individual participant data for all primary and secondary outcome measures will be made available
Citations:
PubMed Identifier
35120546
Citation
Frisoli A, Barsotti M, Sotgiu E, Lamola G, Procopio C, Chisari C. A randomized clinical control study on the efficacy of three-dimensional upper limb robotic exoskeleton training in chronic stroke. J Neuroeng Rehabil. 2022 Feb 4;19(1):14. doi: 10.1186/s12984-022-00991-y.
Results Reference
derived

Learn more about this trial

Upper Limb Task-Oriented Rehabilitation With Robotic Exoskeleton for Hemiparetic Stroke Patients

We'll reach out to this number within 24 hrs