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StrokeNCT02650440

Discrete Versus Rhythmic Gait Training

A study testing Novel Protocol and Standard Protocol in people with Stroke and Cerebral Vascular Disorders, run by Thais Amanda Rodrigues at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Cerebral Vascular Disorders
What is being tested?
Novel Protocol and Standard Protocol
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteBrazil
Study dates
Nov 2014to Sep 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Instituto de Medicina Física e Reabilitação - Lucy Montoro

    São Paulo, 05716-150

Other trials in Brazil

About this study

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

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.

Read the 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.

Being tested
Novel Protocol, Standard Protocol
Keywords
robotics, locomotion, gait, walking, rehabilitation
Medical subject headings
Stroke, Cerebrovascular Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Novel ProtocolProcedure or surgery

    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 ProtocolProcedure or surgery

    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

Study groups in NCT02650440
Study groupRoleWhat they receive
Novel ProtocolExperimentalProgressive 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.
Receives: Procedure: Novel Protocol
Standard ProtocolExperimentalProgressive 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.
Receives: Procedure: Standard Protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and 6 weeks

Secondary outcomes (5)

  1. Six-minute Walking Test (6MWT)

    Change in distance of the gait applied test after intervention as compared to baseline

    Measured: Baseline and 6 weeks

  2. 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.

    Measured: Baseline and 6 weeks

  3. Ten-meters Walking Test (10MWT)

    Change in the time of the gait applied test after intervention as compared to baseline

    Measured: Baseline and 6 weeks

  4. 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

    Measured: Baseline and 6 weeks

  5. 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.

    Measured: Baseline and 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2016 (estimated)
  2. Study startNov 2014
  3. Primary completionMar 2016
  4. Study completionSep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02650440
Sponsor's protocol ID
Robotics in Stroke
Status last verified
May 2017
First submitted
5 Jan 2016
Last updated
18 Sep 2017
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Novel Protocol and Standard Protocol in people with Stroke and Cerebral Vascular Disorders, run by Thais Amanda Rodrigues at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Ambulation Scale (FAC) (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02650440.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2017.

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Discrete Versus Rhythmic Gait Training (NCT02650440) | AzTrials