NCT02082938

Brief Summary

The purpose of this study is to verify if the incorporation of a new brace, which assists in gait rehabilitation, can contribute to the rehabilitation process for stroke patients.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2014

Completed
Last Updated

March 10, 2014

Status Verified

March 1, 2012

Enrollment Period

1 month

First QC Date

March 4, 2014

Last Update Submit

March 6, 2014

Conditions

Keywords

stroke,rehabilitation,hemiparesis,gait training

Outcome Measures

Primary Outcomes (1)

  • distribution of plantar pressures during walking

    To evaluate the distribution of plantar pressures during walking, for individuals with hemiparesis, before and after training with a brace for gait retraining and control of genu recurvatum. To observe the gait evolution of 12 patientes after the trainnig with a orthotic device.

    4 weeks

Study Arms (1)

Bracing

EXPERIMENTAL

Bracing: the patients began four weeks of training the gait with the brace, under the guidance and observation of the physiotherapist belonging to the group of authors of this study.

Device: Bracing

Interventions

BracingDEVICE

Twice a week, for a period of 5 weeks, before the sessions in the physiotherapy clinic the patients participating in the study were asked to walk at a self-selected speed on flat ground along a corridor 50 meters long, with the brace being used for fifteen minutes of gait retraining of the affected side.

Bracing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • the presence of hemiparesis after the stroke, with an evolution time of between 6 and 24 months, the ability to walk without using assistive aids, and the presence of genu recurvatum during the mid-stance in the gait.

You may not qualify if:

  • conditions that would preclude evaluation and training with the brace; for example, the presence of contractures or fixed deformities in the lower limbs, and moderate to severe impairments related to cognition, perception, attention, or language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

StrokeParesis

Interventions

Braces

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthotic DevicesOrthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Officials

  • Éder K Cardoso, Master

    Federal University of Health Science of Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT Éder Kröeff Cardoso Master Degree

Study Record Dates

First Submitted

March 4, 2014

First Posted

March 10, 2014

Study Start

March 1, 2012

Primary Completion

April 1, 2012

Study Completion

January 1, 2014

Last Updated

March 10, 2014

Record last verified: 2012-03