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.
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.
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 group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Conventional physiotherapy for stroke. Receives: Other: Conventional physiotherapy |
| Target group | Experimental | Techniques 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.
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.
- First posted26 Sep 2014 (estimated)
- Study startMar 2011
- Primary completionApr 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario La Fe
- Responsible party
- Principal investigator, M Luz Sanchez, University of Valencia
- Investigators
- Enrique Viosca-Herrero, PhD, Study director, Hospital Universitario La FeJuan-Manuel Belda-Lois, PhD, Study director, Instituto de Biomecanica de ValenciaCeledonia Igual-Camacho, PhD, Study director, University of Valencia
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Assessment of a New Physiotherapy Protocol for Gait Recovery After Stroke Based on Clinical and Functional Criteria
- ClinicalTrials.gov ID
- NCT02250040
- Acronym / sponsor ID
- 2011/0417
- Conditions
- Stroke
- Keywords
- Stroke, Rehabilitation, Physiotherapy, Functional Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Hospital Universitario La Fe
- Study start
- Mar 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 26 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Conventional physiotherapyConventional physiotherapy for stroke. |
| Target group | Experimental | Other: Conventional physiotherapy, Other: Techniques based on patients' functional level were added.Techniques based on patients' functional level were added. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional physiotherapyPhysiotherapy techniques that included muscle training, stretching and endurance. | Other | Control group, Target group |
| Techniques based on patients' functional level were added.The added techniques aimed to improve balance and movement dissociation. | Other | Target group |
Primary outcome
Barthel Index
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2014.
- Derived from this study: PubMed 29775954Sanchez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enrique Viosca-Herrero, PhD study director
Hospital Universitario La Fe
Juan-Manuel Belda-Lois, PhD study director
Instituto de Biomecanica de Valencia
Celedonia Igual-Camacho, PhD study director
University of Valencia
1 site in 1 country: see every site and its status.
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.