StrokeNCT01415843
Observation of Physiotherapy Treatment Sessions - Exploring What Happens in Physiotherapy for Patients After Stroke.
An observational study of Stroke, run by University of Southampton at 2 sites in United Kingdom.
Trial summary
This is the first phase of a study that will investigate the effects that different approaches to physiotherapy have on the expression of associated reactions. During this phase, current practice among neuro-physiotherapists will be explored in relation to: the learning strategies used in stroke rehabilitation, the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 8 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jan 2010to Apr 2010
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stroke will be recruited from two NHS Trusts - Royal Bournemouth and Christchuch Hospitals NHS Foundation Trust and Southampton City Primary Care Trust.
- has suffered a stroke
- is currently receiving active rehabilitation that includes gait re-education
- is exhibiting upper limb deficits
- is able to provide informed consent.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Royal Bournemouth and Christchurch NHS Foundation Trust
Bournemouth, Dorset
Southampton City Primary Care Trust
Southampton, Hampshire
About this study
Official title: Do Implicit and Explicit Learning Strategies Applied During Gait Re-education Influence Concurrent Expression of Associated Reactions in Individuals With Hemiplegia? Phase 1a
This is the first phase of a study that will investigate the effects that different approaches to physiotherapy have on the expression of associated reactions. During this phase, current practice among neuro-physiotherapists will be explored in relation to: the learning strategies used in stroke rehabilitation, the common interventions used in gait re-education, and the strategies adopted for the assessment and management of associated reactions.
Read the detailed description
Associated reactions are unintended and involuntary arm movements, normally seen as bending of the wrist and elbow, that may occur after stroke when a person is doing something effortful such as walking.
The objectives are:
- To provide an insight into the learning strategies used by physiotherapists during the re-education of walking, including the verbal dialogue that takes place and any preferences (overt or subconscious) adopted for one type of learning strategy.
- To develop and refine a description of what is meant by the term "gait re-education"
- To provide an insight into how therapists currently manage associated reactions
This phase of the study will explore these objectives using direct non-participation observation of a number of physiotherapy treatment sessions. This will provide an insight into the nature of the therapy that takes place for retraining walking(e.g. the types of exercises commonly used) and the nature of the learning strategies frequently adopted, including the amount and content of explicit verbal instruction and feedback that is provided to patients.
- Conditions
- Stroke
- Medical subject headings
- Stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2011 (estimated)
- Study startJan 2010
- Primary completionApr 2010
- Study completionApr 2010
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jane Burridge, Professor, Study chair, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01415843
- Sponsor's protocol ID
- 09/H0504/80
- Status last verified
- Apr 2021
- First submitted
- 11 Aug 2011
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Johnson L, Burridge JH, Demain SH. Internal and external focus of attention during gait re-education: an observational study of physical therapist practice in stroke rehabilitation. Phys Ther. 2013 Jul;93(7):957-66. doi: 10.2522/ptj.20120300. Epub 2013 Apr 4.
PubMed 23559523
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Implicit and Explicit Learning Strategies Applied During Gait Re-education Influence Concurrent Expression of Associated Reactions in Individuals With Hemiplegia? Phase 1a
- ClinicalTrials.gov ID
- NCT01415843
- Acronym / sponsor ID
- 09/H0504/80
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 12 Aug 2011 (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.
This is the first phase of a study that will investigate the effects that different approaches to physiotherapy have on the expression of associated reactions. During this phase, current practice among neuro-physiotherapists will be explored in relation to: the learning strategies used in stroke rehabilitation, the common interventions used in gait re-education, and the strategies adopted for the assessment and management of associated reactions.
Detailed description
Associated reactions are unintended and involuntary arm movements, normally seen as bending of the wrist and elbow, that may occur after stroke when a person is doing something effortful such as walking.
The objectives are:
- To provide an insight into the learning strategies used by physiotherapists during the re-education of walking, including the verbal dialogue that takes place and any preferences (overt or subconscious) adopted for one type of learning strategy.
- To develop and refine a description of what is meant by the term "gait re-education"
- To provide an insight into how therapists currently manage associated reactions
This phase of the study will explore these objectives using direct non-participation observation of a number of physiotherapy treatment sessions. This will provide an insight into the nature of the therapy that takes place for retraining walking(e.g. the types of exercises commonly used) and the nature of the learning strategies frequently adopted, including the amount and content of explicit verbal instruction and feedback that is provided to patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stroke will be recruited from two NHS Trusts - Royal Bournemouth and Christchuch Hospitals NHS Foundation Trust and Southampton City Primary Care Trust.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 20 Apr 2021.
- Results publication: PubMed 23559523Johnson L, Burridge JH, Demain SH. Internal and external focus of attention during gait re-education: an observational study of physical therapist practice in stroke rehabilitation. Phys Ther. 2013 Jul;93(7):957-66. doi: 10.2522/ptj.20120300. Epub 2013 Apr 4.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Jane Burridge, Professor study chair
University of Southampton
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by University of Southampton at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01415843, 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 20 Apr 2021.