Clinical trial NCT02250040: Effect of a Physiotherapy Protocol for Gait and Functional Recovery After Stroke
Official title: Development and Assessment of a New Physiotherapy Protocol for Gait Recovery After Stroke Based on Clinical and Functional Criteria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Rehabilitation
Physiotherapy
Functional Recovery
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: Hospital Universitario La Fe
First posted: 2014-09-26
Enrollment: 20
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Barthel Index
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital La Fe
Study officials:
affiliation: Hospital Universitario La Fe
name: Enrique Viosca-Herrero, PhD
role: STUDY_DIRECTOR
affiliation: Instituto de Biomecanica de Valencia
name: Juan-Manuel Belda-Lois, PhD
role: STUDY_DIRECTOR
affiliation: University of Valencia
name: Celedonia Igual-Camacho, PhD
role: STUDY_DIRECTOR
References:
citation: 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.