Discrete Versus Rhythmic Gait Training

• ClinicalTrials.gov Identifier: NCT02650440
• Recruitment Status: Completed
• First Posted: January 8, 2016
• Results First Posted: September 18, 2017
• Last Update Posted: September 18, 2017
• Sponsor: Thais Amanda Rodrigues
• Information provided by (Responsible Party): Thais Amanda Rodrigues, University of Sao Paulo

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.

Condition or disease	Intervention/treatment	Phase
Stroke; Cerebral Vascular Disorders	Procedure: Novel Protocol; Procedure: Standard Protocol	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Robot-assisted Locomotor Training After Severe Stroke: Discrete Versus Rhythmic Movement
• Study Start Date: November 2014
• Actual Primary Completion Date: March 2016
• Actual Study Completion Date: September 2016

Arms and Interventions

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.	Procedure: Novel Protocol; 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.	Procedure: Standard Protocol; 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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Six-minute Walking Test (6MWT) [ Time Frame: Baseline and 6 weeks ]
   Change in distance of the gait applied test after intervention as compared to baseline
2. Time Up and Go (TUG) [ Time Frame: Baseline and 6 weeks ]
   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.
3. Ten-meters Walking Test (10MWT) [ Time Frame: Baseline and 6 weeks ]
   Change in the time of the gait applied test after intervention as compared to baseline
4. Lower Limbs Fugl-Meyer [ Time Frame: Baseline and 6 weeks ]

   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

5. Berg Scale [ Time Frame: Baseline and 6 weeks ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Brazil

Instituto de Medicina Física e Reabilitação - Lucy Montoro

Sao Paulo, Brazil, 05716-150

Sponsors and Collaborators

Thais Amanda Rodrigues

Investigators

• Study Chair: Daniel G Goroso, Doctor; University of Sao Paulo
• Study Chair: Lumy Sawaki, PhD; University of Kentucky

More Information

• Responsible Party: Thais Amanda Rodrigues, Physiotherapist, University of Sao Paulo
• ClinicalTrials.gov Identifier: NCT02650440
• Other Study ID Numbers: Robotics in Stroke
• First Posted: January 8, 2016
• Results First Posted: September 18, 2017
• Last Update Posted: September 18, 2017
• Last Verified: May 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by Thais Amanda Rodrigues, University of Sao Paulo:

robotics; locomotion; gait; walking; rehabilitation

Additional relevant MeSH terms:

Cerebrovascular Disorders; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cardiovascular Diseases