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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Conventional physiotherapy
Techniques based on patients' functional level were added.
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Rehabilitation, Physiotherapy, Functional Recovery

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital La Fe

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Target group

Arm Description

Conventional physiotherapy for stroke.

Techniques based on patients' functional level were added.

Outcomes

Primary Outcome Measures

Barthel Index

Secondary Outcome Measures

Full Information

First Posted
April 2, 2014
Last Updated
September 25, 2014
Sponsor
University of Valencia
Collaborators
Hospital Universitario La Fe
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1. Study Identification

Unique Protocol Identification Number
NCT02250040
Brief Title
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

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia
Collaborators
Hospital Universitario La Fe

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Rehabilitation, Physiotherapy, Functional Recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Conventional physiotherapy for stroke.
Arm Title
Target group
Arm Type
Experimental
Arm Description
Techniques based on patients' functional level were added.
Intervention Type
Other
Intervention Name(s)
Conventional physiotherapy
Intervention Description
Physiotherapy techniques that included muscle training, stretching and endurance.
Intervention Type
Other
Intervention Name(s)
Techniques based on patients' functional level were added.
Intervention Description
The added techniques aimed to improve balance and movement dissociation.
Primary Outcome Measure Information:
Title
Barthel Index
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enrique Viosca-Herrero, PhD
Organizational Affiliation
Hospital Universitario La Fe
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Juan-Manuel Belda-Lois, PhD
Organizational Affiliation
Instituto de Biomecanica de Valencia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Celedonia Igual-Camacho, PhD
Organizational Affiliation
University of Valencia
Official's Role
Study Director
Facility Information:
Facility Name
Hospital La Fe
City
Valencia
ZIP/Postal Code
46009
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
29775954
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, Avon). 2018 Jul;56:18-26. doi: 10.1016/j.clinbiomech.2018.05.003. Epub 2018 May 5.
Results Reference
derived

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

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