Trial document




drksid header

  DRKS00018991

Trial Description

start of 1:1-Block title

Title

Sensory Referral in Stroke - a mixed methods feasibility study

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://www.le.ac.uk/stroke-numbness

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Many people suffer from numbness after stroke. This is dangerous and limits everyday use of hands and feet.
Mirror therapy is well recognised in stroke treatment. But the use of touch applied by someone else during mirror therapy is not well documented. We looked at what is published and at some early clinical documentation about how sensation can be elicited by the use of a mirror illusion. Then we conducted a study with 48 people who haven’t had a stroke to see how the illusion works.
In this study now we want to find out how participants with stroke-numbness respond and how to design a large study with stroke patients from several settings.
Four sessions within three weeks and one follow-up after three months will be scheduled of 1-3 hours duration. We will measure outcomes on sensation, movement ability and quality of life, and record what participants tell us about the experience. Parts of the sessions will be audio- and video-recorded. We will use paint brushes and touch on the hands and feet of the participants, and also rubber hands and feet.
We aim to find 15 adult volunteers from England and Germany who have been suffering from stroke-numbness for longer than 6 months and who can communicate reliably.
We hypothesise that a stroke trial is feasible and acceptable.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Sensory impairment occurs in more than half the population with disability following stroke, limiting motor control and independence, and presenting a risk to health from unnoticed injury. Mirror therapy can improve motor function after stroke whereby the patient watches the reflection of the unaffected limb move in a mirror placed between arms or legs (Thieme et al. 2018). The use of external stimulation in this context has not been evaluated. A Scoping Review of the literature on sensory referral (SR) and a preparatory study with 48 healthy subjects informed the protocol for the current feasibility study which aims to explore SR in chronic stroke and inform the protocol for future international multicentre Randomised Controlled Trial.

The research questions are:
1. What recruitment strategies and rates are feasible for including people with chronic stroke from various settings?
2. Are the proposed interventions and outcome measures acceptable for people with stroke, and what experiences and attitudes do they have?
A mixed methods exploratory, prospective, assessor-blinded experimental study will be conducted.
Participants will be 15 adult volunteers suffering from numbness at least six months after stroke and who are able to communicate with the researchers who are able and willing to comply with all local and procedural study requirements.
They will be recruited from stroke groups and rehabilitation settings in England and Germany, through adverts, emails, phone calls and word of mouth.
Four sessions are scheduled for each participant within a period of 3 weeks and an additional follow-up will be conducted after 3 months. The intervention will be conducted with the participant sitting in a chair. The non-affected hand or foot or a rubber replacement will be stimulated with paint brushes and touch with no more than 30 minutes stimulation time. The sessions of 1-3 hours will be partly video- and audio-recorded.
Baseline data will be collected regarding age, gender, ethnicity, level of education and medical history. Further baseline data include the Barthel Index, NIHSS, star cancellation, line bisection and a creativity test.
Outcomes are measured with the Fugl-Meyer, Box and Block Test (if possible), Berg Balance Scale (if possible), Goal Attainment Scale, EuroQol-5D, and a sensation map.

Measures to control bias in this Mixed Methods study are:
• blinding of the assessor of the videoed outcome measures;
• blinding of statistician for analysis of results;
• member checking of transcripts and other measures.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00018991
  •   2019/11/19
  •   [---]*
  •   yes
  •   Approved
  •   20350-ah-scen:informatics,deptof, University Ethics Sub-Committee for Medicine and Biological Sciences; University of Leicester, University Road, Leicester, LE1 7RH, United Kingdom; URL: www.le.ac.uk
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   I63 -  Cerebral infarction
  •   I61 -  Intracerebral haemorrhage
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   A rubber replacement and, if preferred, the participant's unaffected hand or foot will be stimulated with paint brushes and the researcher's hand. This will be watched by the participant in a mirror reflection. Sensations perceived on the affected side and acceptability will be reported and recorded.
    Baseline data will be collected regarding age, gender, ethnicity, level of education and medical history. Further baseline data include the Barthel Index, NIHSS, star cancellation, line bisection and a creativity test.
    Outcomes are measured with the Fugl-Meyer, Box and Block Test (if possible), Berg Balance Scale (if possible), Goal Attainment Scale, EuroQol-5D, and a sensation map.
    Time points for assessments are the first and forth session (within three weeks) and a follow up after 3 months.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   I-II
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Feasibility Study:
1. What recruitment strategies and rates are feasible for including people with stroke from various settings?
2. Are the proposed interventions and outcome measures acceptable for people with stroke, and what experiences and attitudes do they have?

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Fugl-Meyer Assessment, Box and Block Test, Berg Balance Scale, Goal Attainment Scale, EuroQol-5D, and a sensation map;
questions regarding acceptability and tolerability of assessments and intervention, and regarding quality of the perception with rating of the strength using NRS;
Time points: first, forth and follow-up session.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   United Kingdom
  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2019/11/19
  •   15
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

• Willing and able to give informed consent for participation in the study;
• Aged 18 years or above;
• Has had a physician-confirmed stroke at least 6 months ago and is suffering from unilateral numbness since having had a stroke;
• Able to communicate with the researchers
• Able (in the Investigators’ opinion) and willing to comply with all local and procedural study requirements.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

• Unwillingness or inability to consent;
• Presence of sensory impairment from origin other than stroke or itchy skin;
• Additional severe neurological diseases or any symptoms of tremor;
• Constant pain or pain on touch or pressure in hands or feet;
• Inability to maintain a stable (supported) position of the hand on the table;
• A position that would be painful if sensation was restored;
• Inability to focus attention for 10 minutes;
• Acute major events in the past month;
• Any visual impairment that excludes clear vision of their own foot and hand;
• Any psychosomatic or psychiatric diseases (including drug addictions), where sensory stimulation may cause anxiety or disappointment in case of no-improvement;
• Ladies who are pregnant or lactating;
• Any significant disease or disorder which, after consulting the medical supervisors of the research team, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • University of Leicester
    • Mr.  Dr  Chris  Talbot 
    • University Road
    • LE1 7RH  Leicester
    • United Kingdom
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Schoen Klinik Bad Aibling
    • Mr.  Prof Dr med  Klaus  Jahn 
    • Kolbermoorer Strasse 72
    • 83043  Bad Aibling
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • University of Leicester
    • Ms.  Annegret  Hagenberg 
    • Robert Kilpatrick Clinical Sciences Building, Level 2
    • LE1 7RH  Leicester
    • United Kingdom
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • University of Leicester
    • Ms.  Annegret  Hagenberg 
    • University Road
    • LE1 7RH  Leicester
    • United Kingdom
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • University of Leicester
    • Mr.  Professor  Thompson  Robinson 
    • University Road
    • LE1 7RH  Leicester
    • United Kingdom
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.