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StrokeNCT02250040

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

A study testing Conventional physiotherapy and Techniques based on patients' functional level were added. in people with Stroke, run by University of Valencia at 1 site in Spain.

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 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. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Stroke
What is being tested?
Conventional physiotherapy and Techniques based on patients' functional level were added.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSpain
Study dates
Mar 2011to Jun 2014
Phase
Interventional
Are there results?
None posted in the registry

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Hospital La Fe

    Valencia, Valencia, 46009

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Conditions
Stroke
Being tested
Conventional physiotherapy, Techniques based on patients' functional level were added.
Keywords
Stroke, Rehabilitation, Physiotherapy, Functional Recovery
Medical subject headings
Stroke

What participants receive

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

  • Conventional physiotherapyOther

    Physiotherapy techniques that included muscle training, stretching and endurance.

  • Techniques based on patients' functional level were added.Other

    The added techniques aimed to improve balance and movement dissociation.

Study groups in NCT02250040
Study groupRoleWhat they receive
Control groupActive comparatorConventional physiotherapy for stroke.
Receives: Other: Conventional physiotherapy
Target groupExperimentalTechniques based on patients' functional level were added.
Receives: Other: Conventional physiotherapy; Other: Techniques based on patients' functional level were added.

What is being measured

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

  1. Barthel Index

    Measured: up to 6 months

Timeline

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

  1. First posted26 Sep 2014 (estimated)
  2. Study startMar 2011
  3. Primary completionApr 2014
  4. Study completionJun 2014

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, Care provider, Investigator
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02250040
Sponsor's protocol ID
2011/0417
Status last verified
Sep 2014
First submitted
2 Apr 2014
Last updated
26 Sep 2014
Results posted
No
Data monitoring committee
No

Publications

  • Sanchez-Sanchez ML, Belda-Lois JM, Mena-Del Horno S, Viosca-Herrero E, Igual-Camacho C, Gisbert-Morant B. A new methodology based on functional principal component analysis to study postural stability post-stroke. Clin Biomech (Bristol). 2018 Jul;56:18-26. doi: 10.1016/j.clinbiomech.2018.05.003. Epub 2018 May 5.

    PubMed 29775954

Questions about this trial

What is this clinical trial studying?

A study testing Conventional physiotherapy and Techniques based on patients' functional level were added. in people with Stroke, run by University of Valencia at 1 site in Spain.

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 5 inclusion and 4 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 26 Sep 2014. 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 Spain. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Barthel Index (time frame: up to 6 months). 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 NCT02250040, which also lists 1 linked publication.

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 26 Sep 2014.

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