- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02650440
Discrete Versus Rhythmic Gait Training
Robot-assisted Locomotor Training After Severe Stroke: Discrete Versus Rhythmic Movement
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sao Paulo, Brazil, 05716-150
- Instituto de Medicina Física e Reabilitação - Lucy Montoro
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinical diagnosis of stroke and image with hemiparesis left or right;
- No more that one ischemic or hemorrhagic stroke episode;
- 06 months post-stroke;
- Verified clinical stability on medical evaluation;
- Spasticity level I or II in the Ashworth scale;
- Score 1-2 in the Functional Ambulation Scale (FAC);
- Signed informed consent.
Exclusion Criteria:
- Dependence to perform activities of daily living before the stroke;
- Lack of clinical indications for exercises (such as cardiopulmonary instability and uncontrolled diabetes);
- Severe cognitive impairment;
- Serious psychiatric change that needs psychiatric care;
- Severe osteoporosis;
- Severe spasticity of the lower limbs, deformities or fixed contractures that prevent the achievement of movements;
- Lack of resistance or disabling fatigue;
- Body weight greater than 150 kg;
- Unstable angina or other untreated heart disease;
- Chronic obstructive pulmonary disease;
- Unconsolidated fractures, pressure sores;
- Other neurological diseases.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Novel Protocol
Progressive decrease of speed and guidance force on robotic gait training.
Initial speed is 1.4 km/h and final speed is 1.0 km/h.
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All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup).
Novel (discrete) robot-assisted LT-BWST used progressive decrease in speed.
Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h.
The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week.
The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject.
|
Experimental: Standard Protocol
Progressive increase of speed and decrease of guidance force on robotic gait training.
Initial speed is 1.4 km/h and final speed is 1.9 km/h.
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All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup).
Standard (rhythmic) robot-assisted LT-BWST used progressively increased speed each week.
Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h.
The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week.
The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Ambulation Scale (FAC)
Time Frame: Baseline and 6 weeks
|
The Functional Ambulation Scale (FAC) assesses an individual's independence during gait and follows a six-level scale: 0 - Patient can not walk or ask for help from two or more people; 1 - Patient requires continuous support from a person who assists with weight and balance; 2 - Patient needs continuous or intermittent support from a person to help with balance and coordination; 3 - Patient required for a person without physical contact; 4 - Patient can walk independently on the floor, but requires help on stairs and ramps; 5 - Patient can walk independently. This study compared the gait independence by the FAC between the two Arms, after intervention as compared to baseline. |
Baseline and 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Six-minute Walking Test (6MWT)
Time Frame: Baseline and 6 weeks
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Change in distance of the gait applied test after intervention as compared to baseline
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Baseline and 6 weeks
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Time Up and Go (TUG)
Time Frame: Baseline and 6 weeks
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This test assesses the level of mobility of the individual to measure the time spent to get up from a chair, walk a distance of 3 meters, turn around and return.
This study compared the change in the time of the gait applied test after intervention as compared to baseline.
|
Baseline and 6 weeks
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Ten-meters Walking Test (10MWT)
Time Frame: Baseline and 6 weeks
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Change in the time of the gait applied test after intervention as compared to baseline
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Baseline and 6 weeks
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Lower Limbs Fugl-Meyer
Time Frame: Baseline and 6 weeks
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The Fugl Meyer Scale is a cumulative numerical scoring system that is assessed by an individual: range of motion, pain, tenderness, upper and lower extremity motor function and balance, plus coordination and speed of movement, with total 226 points. A three-point ordinal scale is applied to each item: 0 - can not be performed, 1-performed partially and 2-performed completely. For this study it was only an evaluation of motor function of the extremity of lower limbs with a total score of 0 to 34 points. The lower score indicates greater motor impairment. This study compared the change in motor function of lower limbs applied scale after intervention as compared to baseline |
Baseline and 6 weeks
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Berg Scale
Time Frame: Baseline and 6 weeks
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Berg Scale is a functional scale of equilibrium performance, based on 14 common everyday items that evaluate the static and dynamic balance.
The maximum scale score is 56 and each scale item has five alternatives ranging from 0 to 4 points.
A score below 45 is considered a fall risk.
This study comparede the change in the balance control applied scale after intervention as compared to baseline.
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Baseline and 6 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Daniel G Goroso, Doctor, University of Sao Paulo
- Study Chair: Lumy Sawaki, PhD, University of Kentucky
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Robotics in Stroke
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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