Effects of Robotic Rehabilitation in Post-Stroke Patients

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Primary Purpose

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Intervention group (Robotic rehabilitation)

Control group (Conventional physiotherapy)

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Robotics, Electric stimulation

Eligibility Criteria

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

Inclusion Criteria:

Medical diagnosis of ischemic stroke, in the subacute phase (after 48 hours);
To present hemiparesis or muscle weakness defined by the Medical Research Council (MRC) score;
To understand simple commands and being able to report signs of discomfort.

Exclusion Criteria:

Severe psychomotor agitation;
Recent acute myocardial infarction (24 hours) and/or uncontrolled arrhythmias;
Intracranial hypertension (PIC> 20mmHg);
Uncontrolled hypertension (PAS> 230 mmHg and PAD> 120 mmHg) or PAM <60 mmHg;
Decompensated heart failure;
To present important hemodynamic changes during training;
Peripheral vascular disease in the lower limb such as untreated deep vein thrombosis;
Unconsolidated fractures or severe joint pain;
Feverish state;
Smokers;
Epidermal lesions on the thighs that make it impossible to place self-adhesive electrodes for electrical stimulation;
Pre-existing neuromuscular disease;
Signs of rhabdomyolysis;
Pregnancy.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robotic rehabilitation

Conventional physiotherapy

Arm Description

Robotic rehabilitation with Erigo® equipment (Hocoma, Volketswil, Switzerland).

The protocol will be based on lower limb exercises, aiming at maintaining and gaining muscle strength through passive, assisted or active mobilization, when possible, on the affected side.

Outcomes

Primary Outcome Measures

Functionality

The change in functionality will be assessed using the Fugl-Meyer Scale. This scale consists of six domains: range of motion, pain, sensitivity, motor function of the upper and lower extremities, balance, coordination and speed. The score for each item ranges from 0 to 2, where 0 = cannot be performed; 1 = partially accomplished; 2 = completely accomplished. The total score ranges from 0 to 266 points and the higher the score the better the functionality.

Secondary Outcome Measures

Muscle strength

The change in muscle strength will be assessed by the Medical Research Council (MRC) scale and by test of maximum repetition (1RM)

Quadriceps muscle thickness

The change in quadriceps muscle thickness will be evaluated for the acquisition of ultrasound images using a high resolution ultrasound device (Vivid-i, GE, USA). In order to verify the thickness of the muscle, the distance between the superficial and deep aponeurosis is measured.The thickness is given in centimeters.

Echogenicity of the rectus femoris muscle

The change in echogenicity will be evaluated for the acquisition of ultrasound images of the rectus femoris muscle using a high resolution ultrasound device (Vivid-i, GE, USA). To check the echogenicity of the rectus femoris an image of the cross-sectional area of the muscle will be taken. The echogenicity measurement is given in an arbitrary unit.

Spasticity

The change in spasticity will be assessed by the Modified Ashworth Scale. This scale consists of an ordinal classification of 5 points for grading the resistance found during passive stretching, with 0 indicating normal muscle tone and 4 severe increase in tone. The higher the score, the greater the spasticity.

Mobility

The change in mobility will be assessed using the Timed Up and Go test (TUG), which will be associated with an inertial sensor

Disability and dependence

The change in disability and dependency will be assessed using the Modified Rankin Scale. This instrument has 6 scores, where: 0 = asymptomatic; 1 = symptoms without disabilities; 2 = mild disability; 3 = moderate disability; 4 = moderate to severe disability; 5 = severe disability and 6 = death. The higher the score, the greater the degree of disability and dependence.

Quality of life indicator

The change in quality of life will be assessed using the EuroQol-5D questionnaire. This is a generic instrument that assesses mobility, personal care, usual activities, pain and anxiety/depression. It allows to generate a global index of the value of an individual's health status. The number 1 indicates the best state of health (perfect health) and 0 the worst state of health (death).

Heart rate

Heart rate will be assessed by pulse oximetry

Peripheral arterial oxygen saturation

Peripheral arterial oxygen saturation will be assessed by pulse oximetry

Systolic blood pressure

Systolic blood pressure will be assessed through sphygmomanometer

Diastolic blood pressure

Diastolic blood pressure will be assessed through sphygmomanometer

Muscle pain

Pain perception will be assessed using the Visual Analog Scale. This scale ranges from 0 to 10, where 0 indicates no pain and 10 maximum pain.

Lower limb fatigue

Lower limb fatigue will be assessed by Borg effort subjective perception scale. This scale ranges from 0 to 10, where 0 indicates no effort or fatigue and 10 indicates maximum effort.

Time of hospital stay

The days between admission and hospital discharge will be counted

Full Information

NCT ID

NCT04494685

First Posted

May 29, 2020

Last Updated

July 28, 2020

Sponsor

Federal University of Health Science of Porto Alegre

1. Study Identification

Unique Protocol Identification Number

NCT04494685

Brief Title

Effects of Robotic Rehabilitation in Post-Stroke Patients

Official Title

Effects of Robotic Rehabilitation in Post-Stroke Patients: A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Unknown status

Study Start Date

August 1, 2020 (Anticipated)

Primary Completion Date

February 1, 2021 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Federal University of Health Science of Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study aims to evaluate the effect of robotic rehabilitation through training on a robot-assisted orthostatic board and neuromuscular electrical stimulation (NMES) on functionality in post-stroke patients. In this randomized controlled trial the patients will be allocated to a control group (which will receive conventional physiotherapy) or or to intervention group (which will receive conventional physiotherapy and robotic rehabilitation). Interventions will occur every day in the hospital phase and three times/week after discharge, totaling 18 sessions.The groups will be evaluated prior to any physiotherapy intervention, in the 10h session and at the end of six weeks of treatment (or 18 sessions).The following outcomes will be measured: functionality, peripheral muscle strength, muscle architecture and echogenicity, spasticity, cardiorespiratory repercussions, mobility, disability and dependence, quality of life and time of hospital stay.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

Stroke, Robotics, Electric stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Robotic rehabilitation

Arm Type

Experimental

Arm Description

Robotic rehabilitation with Erigo® equipment (Hocoma, Volketswil, Switzerland).

Arm Title

Conventional physiotherapy

Arm Type

Active Comparator

Arm Description

The protocol will be based on lower limb exercises, aiming at maintaining and gaining muscle strength through passive, assisted or active mobilization, when possible, on the affected side.

Intervention Type

Device

Intervention Name(s)

Intervention group (Robotic rehabilitation)

Other Intervention Name(s)

Erigo®

Intervention Description

Robotic rehabilitation with Erigo® equipment (Hocoma, Volketswil, Switzerland). The training protocol has a progression of the board inclination up to 90º associated with flexion/extension movements of the knees and hips, with time evolution of up to 40 minutes. Such equipment is associated with electrostimulation of the quadriceps, hamstrings, sural triceps and anterior tibialis.

Intervention Type

Other

Intervention Name(s)

Control group (Conventional physiotherapy)

Intervention Description

Knee and hip flexion and extension movements, hip adduction, and abduction, respecting the articular physiology of each joint. Weight transfer will also be performed in the sitting and standing position, mini squat, and gait training. All exercises will have a total of 10 repetitions in three sets. In the end, stretching of the upper and lower limbs will be performed.

Primary Outcome Measure Information:

Title

Functionality

Description

The change in functionality will be assessed using the Fugl-Meyer Scale. This scale consists of six domains: range of motion, pain, sensitivity, motor function of the upper and lower extremities, balance, coordination and speed. The score for each item ranges from 0 to 2, where 0 = cannot be performed; 1 = partially accomplished; 2 = completely accomplished. The total score ranges from 0 to 266 points and the higher the score the better the functionality.

Time Frame

Baseline, after 3 weeks and after 6 weeks

Secondary Outcome Measure Information:

Title

Muscle strength

Description

The change in muscle strength will be assessed by the Medical Research Council (MRC) scale and by test of maximum repetition (1RM)

Time Frame

Baseline, after 3 weeks and after 6 weeks.

Title

Quadriceps muscle thickness

Description

The change in quadriceps muscle thickness will be evaluated for the acquisition of ultrasound images using a high resolution ultrasound device (Vivid-i, GE, USA). In order to verify the thickness of the muscle, the distance between the superficial and deep aponeurosis is measured.The thickness is given in centimeters.

Time Frame

Baseline and after 6 weeks

Title

Echogenicity of the rectus femoris muscle

Description

The change in echogenicity will be evaluated for the acquisition of ultrasound images of the rectus femoris muscle using a high resolution ultrasound device (Vivid-i, GE, USA). To check the echogenicity of the rectus femoris an image of the cross-sectional area of the muscle will be taken. The echogenicity measurement is given in an arbitrary unit.

Time Frame

Baseline and after 6 weeks

Title

Spasticity

Description

The change in spasticity will be assessed by the Modified Ashworth Scale. This scale consists of an ordinal classification of 5 points for grading the resistance found during passive stretching, with 0 indicating normal muscle tone and 4 severe increase in tone. The higher the score, the greater the spasticity.

Time Frame

Baseline, after after 3 weeks and after 6 weeks

Title

Mobility

Description

The change in mobility will be assessed using the Timed Up and Go test (TUG), which will be associated with an inertial sensor

Time Frame

After 3 weeks and after 6 weeks

Title

Disability and dependence

Description

The change in disability and dependency will be assessed using the Modified Rankin Scale. This instrument has 6 scores, where: 0 = asymptomatic; 1 = symptoms without disabilities; 2 = mild disability; 3 = moderate disability; 4 = moderate to severe disability; 5 = severe disability and 6 = death. The higher the score, the greater the degree of disability and dependence.

Time Frame

Baseline and after 6 weeks

Title

Quality of life indicator

Description

The change in quality of life will be assessed using the EuroQol-5D questionnaire. This is a generic instrument that assesses mobility, personal care, usual activities, pain and anxiety/depression. It allows to generate a global index of the value of an individual's health status. The number 1 indicates the best state of health (perfect health) and 0 the worst state of health (death).

Time Frame

Baseline and after 6 weeks

Title

Heart rate

Description

Heart rate will be assessed by pulse oximetry

Time Frame