Effect of a Physiotherapy Protocol for Gait and Functional Recovery After Stroke

September 25, 2014 updated by: M Luz Sanchez, University of Valencia

Development and Assessment of a New Physiotherapy Protocol for Gait Recovery After Stroke Based on Clinical and Functional Criteria

The purpose of this study was to identify and evaluate the effect of a new protocol of physiotherapy to retrain walking ability after stroke in subjects older than fifty-five. This protocol was composed of specific, clearly defined and reproducible techniques, based on clinical and functional criteria.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Stroke is a major cause of morbidity and mortality in adults and the leading cause of disability in all developed countries. Its incidence is approximately one million per year in the European Union.

It produces a huge social impact, not only because of mortality but also by the high demand for health and social services that involve its disabling effects on more than thirty thousand Spanish every year. Hemiplegia is the most common physical consequence of stroke and it is defined as the complete paralysis of the upper and lower extremities of one body side. However, other consequences as perceptual, cognitive, sensory and communication problems should be considered in the physiotherapy treatment.

Age is the most important risk indicator of stroke as it represents an exponential increase in incidence. After the age of 55 the risk doubles for every decade and triples at 80. After rehabilitation, most people who have suffered a stroke get to walk independently or with some technical help, but approximately 50-60% continue to have a certain degree of motor impairment and approximately 50% are, at least in part, dependent for daily life activities. Therefore, gait recovery is one of the main objectives in the rehabilitation process of stroke survivors.

Regarding the process of rehabilitation after stroke, currently, there is insufficient evidence to conclude that any of the physical therapy approaches is more effective to promote recovery of lower limb function or postural control than any other. Thus, future research should focus on determining the effectiveness of individual techniques clearly described and specific treatments for each problem regardless of their approach. Furthermore, after reviewing the different approaches of physiotherapy rehabilitation after stroke, no physiotherapy treatment protocols based on clinical status of the patient have been found. Instead, vague and general instructions are given, so it is necessary to clarify what to do, when and what is the effectiveness of these techniques.

On the other hand, studies have scarcely taken into account the special characteristics of the elderly as a population group so involved in this pathology.

This study aims at addressing these issues, since its main objective is to identify and evaluate the effect of a protocol of physiotherapy to retrain walking ability after stroke in patients older than fifty-five, composed of specific, clearly defined and reproducible techniques, based on clinical and functional criteria.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46009
        • Hospital La Fe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Having suffered a single stroke episode with residual hemiparesis
  • Being candidate to begin a rehabilitation programme
  • Being able to walk before suffering the stroke
  • Having the ability to understand and follow simple instructions
  • Being hemodynamically stable within the first week after stroke

Exclusion Criteria:

  • Poor vital prognosis
  • Pathologies or disorders hampering the development of the study such as: blindness, prosthetics, sensory disorders, severe cognitive impairment and so on
  • Absence of motor impairments after stroke
  • Pre-stroke disorders that affected the ability to walk

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
Conventional physiotherapy for stroke.
Other: Conventional physiotherapy
Physiotherapy techniques that included muscle training, stretching and endurance.
Experimental: Target group
Techniques based on patients' functional level were added.
Other: Conventional physiotherapy
Physiotherapy techniques that included muscle training, stretching and endurance.
Other: Techniques based on patients' functional level were added.
The added techniques aimed to improve balance and movement dissociation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Barthel Index
Time Frame: up to 6 months
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valencia

Collaborators

Hospital Universitario La Fe

Investigators

  • Study Director: Enrique Viosca-Herrero, PhD, Hospital Universitario La Fe
  • Study Director: Juan-Manuel Belda-Lois, PhD, Instituto de Biomecanica de Valencia
  • Study Director: Celedonia Igual-Camacho, PhD, University of Valencia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

April 2, 2014

First Submitted That Met QC Criteria

September 25, 2014

First Posted (Estimate)

September 26, 2014

Study Record Updates

Last Update Posted (Estimate)

September 26, 2014

Last Update Submitted That Met QC Criteria

September 25, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/0417

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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