Back to resultsDiscrete Versus Rhythmic Gait Training
Primary Purpose
Stroke, Cerebral Vascular Disorders
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Novel Protocol
Standard Protocol
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring robotics, locomotion, gait, walking, rehabilitation
Eligibility Criteria
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.
Sites / Locations
- Instituto de Medicina Física e Reabilitação - Lucy Montoro
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Novel Protocol
Standard Protocol
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Functional Ambulation Scale (FAC)
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.
Secondary Outcome Measures
Six-minute Walking Test (6MWT)
Change in distance of the gait applied test after intervention as compared to baseline
Time Up and Go (TUG)
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.
Ten-meters Walking Test (10MWT)
Change in the time of the gait applied test after intervention as compared to baseline
Lower Limbs Fugl-Meyer
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
Berg Scale
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02650440
Brief Title
Discrete Versus Rhythmic Gait Training
Official Title
Robot-assisted Locomotor Training After Severe Stroke: Discrete Versus Rhythmic Movement
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Thais Amanda Rodrigues
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this study is to compare the effects of novel versus standard locomotor training using a robotic gait orthosis (LT-RGO) after stroke. The hypothesis is that the novel LT-RGO protocol, by establishing a progressive decrease in gait velocity and guidance force, may facilitate greater motor recovery compared to the use of a standard protocol.
Detailed Description
Standard (rhythmic) robot-assisted locomotor training on a bodyweight-supported treadmill (LT-BWST) used progressively increased speed each week. Novel (discrete) robot-assisted LT-BWST used progressive decrease in speed. The novel approach of slowing down the treadmill reduced momentum. If speed had been increased (standard approach), momentum would have increased (momentum = mass * velocity); and the resulting, passive propulsion of momentum would have diminished the role of cortical skills needed to plan, initiate, and overtly control gait. In sum, the novel protocol used a slower-than-standard treadmill speed in order to provide a window of time sufficient for the corticomotor system to process information, learn, and adjust its response to internal and external feedback (eg, proprioceptive input; therapist input) during robot-assisted LT-BWST.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cerebral Vascular Disorders
Keywords
robotics, locomotion, gait, walking, rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Novel Protocol
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Protocol
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Novel Protocol
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Standard Protocol
Intervention Description
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
Primary Outcome Measure Information:
Title
Functional Ambulation Scale (FAC)
Description
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.
Time Frame
Baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Six-minute Walking Test (6MWT)
Description
Change in distance of the gait applied test after intervention as compared to baseline
Time Frame
Baseline and 6 weeks
Title
Time Up and Go (TUG)
Description
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.
Time Frame
Baseline and 6 weeks
Title
Ten-meters Walking Test (10MWT)
Description
Change in the time of the gait applied test after intervention as compared to baseline
Time Frame
Baseline and 6 weeks
Title
Lower Limbs Fugl-Meyer
Description
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
Time Frame
Baseline and 6 weeks
Title
Berg Scale
Description
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.
Time Frame
Baseline and 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel G Goroso, Doctor
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lumy Sawaki, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Study Chair
Facility Information:
Facility Name
Instituto de Medicina Física e Reabilitação - Lucy Montoro
City
Sao Paulo
ZIP/Postal Code
05716-150
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Discrete Versus Rhythmic Gait Training
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