Discrete Versus Rhythmic Gait Training

NCT02650440 | Completed Results DMC

• 1 other identifier: Robotics in Stroke
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Cerebral Vascular Disorders

Keywords

robotics; locomotion; gait; walking; rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Six-minute Walking Test (6MWT)

  Baseline and 6 weeks

• Time Up and Go (TUG)

  Baseline and 6 weeks

• Ten-meters Walking Test (10MWT)

  Baseline and 6 weeks

• Lower Limbs Fugl-Meyer

  Baseline and 6 weeks

• Berg Scale

  Baseline and 6 weeks

Study Arms (2)

Novel Protocol

EXPERIMENTAL

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

Standard Protocol

EXPERIMENTAL

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

Interventions

Novel Protocol PROCEDURE

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.

Novel Protocol

Standard Protocol PROCEDURE

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

Standard Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of stroke and image with hemiparesis left or right;
• No more that one ischemic or hemorrhagic stroke episode;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thais Amanda Rodrigues: lead

Study Sites (1)

Instituto de Medicina Física e Reabilitação - Lucy Montoro

São Paulo, 05716-150, Brazil

Location

MeSH Terms

Conditions

Stroke; Cerebrovascular Disorders

Interventions

AIEOP acute lymphoblastic leukemia protocol

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Thais A. Rodrigues, MS, PT.
• Organization: Coordination of Improvement of Higher Level Personnel - CAPES

faleconosco@capes.gov.br

55 (61) 2022-6002

Study Officials

• Daniel G Goroso, Doctor

  University of Sao Paulo

  STUDY CHAIR

• Lumy Sawaki, PhD

  University of Kentucky

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: January 5, 2016
• First Posted: January 8, 2016
• Study Start: November 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 18, 2017
• Results First Posted: September 18, 2017

Record last verified: 2017-05

Locations

BR (1)