Discrete Versus Rhythmic Gait Training

Stroke Clinical Trial

Official title:

Robot-assisted Locomotor Training After Severe Stroke: Discrete Versus Rhythmic Movement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02650440
• Other study ID #: Robotics in Stroke
• Status: Completed
• Phase: N/A
• First received: January 5, 2016
• Last updated: May 2, 2017
• Start date: November 2014
• Est. completion date: September 2016

Study information

• Verified date: May 2017
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Vascular Disorders
• Cerebrovascular Disorders
• Stroke
• Vascular Diseases

Intervention

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.
• 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

Locations

Country	Name	City	State
Brazil	Instituto de Medicina Física e Reabilitação - Lucy Montoro	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Thais Amanda Rodrigues

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 6 weeks
Secondary	Six-minute Walking Test (6MWT)	Change in distance of the gait applied test after intervention as compared to baseline	Baseline and 6 weeks
Secondary	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.	Baseline and 6 weeks
Secondary	Ten-meters Walking Test (10MWT)	Change in the time of the gait applied test after intervention as compared to baseline	Baseline and 6 weeks
Secondary	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	Baseline and 6 weeks
Secondary	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.	Baseline and 6 weeks