StrokeEarly Phase 1SaeboFlexNCT01453010
Self-directed Upper Limb Training Using a SaeboFlex in Acute Stroke
A Early Phase 1 study testing Self-directed Upper Limb SaeboFlex Training in people with Stroke, run by Colchester Hospital University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Arm and hand weakness as a result of stroke occurs in approximately 70% of stroke survivors and causes huge loss of function and independence. A wide range of treatment approaches have been developed to improve motor recovery. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Self-directed Upper Limb SaeboFlex Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2011to May 2012
- Phase
- Early Phase 1
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects will:
- Be either in-patients on Colchester Stroke Unit or,
- Out-patients following an acute stroke admission to Colchester Stroke Unit
- Be adults who have suffered a stroke between 3 and 84 days before recruitment
- Have an anterior circulation stroke - i.e. must have weakness not ataxia
- Have a substantially paretic hand and fingers and meet the criteria for the SaeboFlex orthosis as below
Show all 15Show fewer
- Have a previously fully functional upper limb (i.e. previous weakness, severe movement disorders, severe Rheumatoid Arthritis )
- Be able to participate in self directed therapy (i.e. no severe visual or cognitive deficits precluding participation task repetitive practice and recording training times)
- Are medically fit to participate in repetitive task practice as determined by the consultant (or GP if out-patient).
- Saebo Flex requirements (inclusion criteria)
- Subjects must have:
- A minimum of 15 degrees passive wrist extension (fingers must be extended)
- At least 15 degrees active shoulder motion in any plane
- At least 15 degrees elbow flexion
- At least ¼ range of active finger flexion (IP) flexion
Who cannot join
- Patients that are able to open and close his/her hand completely, 10 times keeping the wrist neutral while maintaining his / her maximum shoulder flexion are too good for the Saebo-flex. Other treatment options should be considered.
- Severe joint deformities that could be worsened by using an orthosis, i.e. RA
- Those patients with extremely poor skin integrity which may be cause irritation or skin damage.
- We will not exclude stroke survivors on the basis of age or gender but subjects will need to be motivated for self-directed study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Colchester Hospital University Foundational NHS Trust
Colchester, Essex, CO45JL
Rebecca Stuck, BSc, 01206 745912, rebecca.stuck@colchesterhospital.nhs.uk
Rebecca Stuck, BSc
About this study
Official title: Self-directed Upper Limb Training Using a SaeboFlex With Acute Stroke Patients: 8 Single Case Reviews
Arm and hand weakness as a result of stroke occurs in approximately 70% of stroke survivors and causes huge loss of function and independence. A wide range of treatment approaches have been developed to improve motor recovery. Despite treatments, such as Constraint Induced Movement Therapy, showing promise, these in large have been have focused on high-intensity and repetitive task-specific practice. Patients with little hand or finger movements however may not be able to participate actively in task specific training.
The SaeboFlex is a dynamic orthosis, with a spring-loaded feature that facilitates opening of the fingers and hand. This allows the patient to grasp and release objects repeatedly, hence enabling participation in repetitive task practice and increasing potential for motor recovery. Despite the SaeboFlex being used successfully in several centers in the country and internationally, research to provide evidence of effectiveness is scarce. As a consequence funding for the SaeboFlex is limited and usually requires patients' to fund their own.
Read more
The study aims to explore the potential benefits and feasibility of participating in a Self-directed SaeboFlex training program to allow repetitive task practice in patients early after stroke.
Subjects will undergo a 12-week training program comprising of a maximum of 3 x 45 minute sessions a day. Activities focus on grasping and releasing balls and reaching for targets, wearing the SaeboFlex for the majority of the session. At the end of each session the SaeboFlex is removed and the hand is incorporated into functional tasks as able. Subjects will be set individualized training program by a Saebo-trained therapist. The program will be graded and progressed at a rate that is appropriate to each individual.
The study will measure and follow-up 8 subjects to explore improvements in recovery and functional ability of the upper limb and affect on dependency levels. It will also explore the level of intensity patients early after stroke can tolerate and how they participate in self-directed therapy. All patients will meet the inclusion criteria and be motivated to undergo the specific SaeboFlex self-directed training program. Subjects will record the time and intensity of their training sessions and also their routine upper limb therapy. Patients will be assessed before, during and after the 3 months training. If these cases show promise the study will support the need for large trials including clinical efficacy and dose finding studies.
- Conditions
- Stroke
- Being tested
- Self-directed Upper Limb SaeboFlex Training
- Keywords
- SaeboFlex, Stroke rehabilitation, Upper Limb Rehabilitation, Acute Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-directed Upper Limb SaeboFlex TrainingOther
Participants undergo a 12 week self directed upper limb training programme with the SaeboFlex upper limb orthosis. Training consists of a maximum of 3 x 45 minute sessions a day.
Participants are closely monitored at least once a week by a saebo-trained therapist.
| Study group | Role | What they receive |
|---|---|---|
| 8 individual case reviews | Experimental | SaeboFlex Self-directed training Receives: Other: Self-directed Upper Limb SaeboFlex Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Action Research Arm Test (ARAT)
Ability to use the paretic upper limb in functional activity. The ARAT is a test of upper limb function with subsections covering grasp, grip, pinch and gross movement. As the SaeboFlex is aimed at achieving grasp and release this measure appears very appropriate. It has good validity and reliability and is widely used in clinical research.
Measured: Change from Baseline in upper limb function to 4, 8 and 12 weeks
Motricity Index (MI)
The Motricity Index (MI) is a clinical measure of the ability to voluntarily contract paretic muscle. It is an ordinal score with six levels of measurement within each of three categories for the upper limb (pinch grip, elbow flexion and shoulder abduction), has been used widely in clinical research, is valid, reliable and sensitive to change after stroke.
Measured: Change from Baseline in upper limb voluntary contraction to 4, 8 and 12 weeks
Secondary outcomes (7)
Motor Assessment Scale- Upper Limb Section (UL-MAS).
The UL-MAS covers three upper limb subsets: upper arm function (six), hand movements and advanced hand activities. Each subtest is scored out of 6, with a maximum score of 18. It has quite recently been recommend that the UL-MAS should be scored non-hierarchally, meaning that every item within the subsets should be scored regardless of its place within the hierarchy. The acceptable internal consistency score obtained verifies the validity and reliability of using the UL-MAS as an independent scale.
Measured: Change from Baseline in upper limb function to 12 weeks
Visual Analogue Scale
A Visual Analogue Scales (VAS) is a type of rating scale that is commonly used to measuring an individuals' rating of their own health. A scale from 1 to10 shall be used for a subjective score of how much the subject rates his or her ability to use their arm in functional tasks
Measured: Change from Baseline to 12 weeks
Modified Barthel Index (MBI)
The Modified Barthel Index is used in the stroke pathway on the ward as part of routine practice.
It is widely used as assessment tools for clinical decision-making and outcome measurement in clinical research. It has good inter-rater reliability. The original Barthel Index was modified to increase sensitivity to change in functional ability and levels of dependence.
Measured: Change from Baseline in Independence level to 4, 8 and 12 weeks
Stroke Impact Scale (SIS)
The Stroke Impact Scale was developed based on feedback from patients and their caregivers. It measures the aspects of stroke recovery which were found to be important to patients and caregivers as well as stroke experts. After intensive psychometric testing the 59 item Stroke Impact Scale Version 3.0 was developed. The 59 questions of the SIS are broken down into eight domains including strength, hand function, mobility, and activities of daily living, emotion, memory, communication and social participation
Measured: Change from Baseline to 12 weeks
Berg Balance Test
The Berg Balance Scale has been identified as the most commonly used assessment tool across the continuum from acute care to community-based care in stroke rehabilitation. It has been demonstrated to have strong psychometric properties and be sensitive to change. Balance is not directly linked to independence but is a good predictor of mobility levels and risk of falls, and therefore considered an important measure to include.
Measured: Change from Baseline in balance to 4, 8 and 12 weeks
Questionnaire
These will be carried out at the end of the 12 week training period. The interview will include a set list of questions with open ended answers to enable patients to describe how they found the training and whether their expectations were met.
Measured: 12 weeks
Adverse effects or events monitoring and recording
Any complaints of pain, prolonged reduction in function, reduction on soft tissue length, tone or effects on skin integrity are unexpected but will be closely monitored and recorded
Measured: throughout 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colchester Hospital University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Rebecca Stuck, BSc, Principal investigator, Colchester Hospital University Foundation NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01453010
- Sponsor's protocol ID
- 11/H0302/8
- Acronym
- SaeboFlex
- Status last verified
- Oct 2011
- First submitted
- 8 Sep 2011
- Last updated
- 17 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-directed Upper Limb Training Using a SaeboFlex With Acute Stroke Patients: 8 Single Case Reviews
- ClinicalTrials.gov ID
- NCT01453010
- Acronym / sponsor ID
- SaeboFlex / 11/H0302/8
- Conditions
- Stroke
- Keywords
- SaeboFlex, Stroke rehabilitation, Upper Limb Rehabilitation, Acute Stroke
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Colchester Hospital University NHS Foundation TrustOther government
- Study start
- May 2011
- Primary completion
- May 2012 (estimated)
- First posted
- 17 Oct 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.
Arm and hand weakness as a result of stroke occurs in approximately 70% of stroke survivors and causes huge loss of function and independence. A wide range of treatment approaches have been developed to improve motor recovery. Despite treatments, such as Constraint Induced Movement Therapy, showing promise, these in large have been have focused on high-intensity and repetitive task-specific practice. Patients with little hand or finger movements however may not be able to participate actively in task specific training.
The SaeboFlex is a dynamic orthosis, with a spring-loaded feature that facilitates opening of the fingers and hand. This allows the patient to grasp and release objects repeatedly, hence enabling participation in repetitive task practice and increasing potential for motor recovery. Despite the SaeboFlex being used successfully in several centers in the country and internationally, research to provide evidence of effectiveness is scarce. As a consequence funding for the SaeboFlex is limited and usually requires patients' to fund their own.
The study aims to explore the potential benefits and feasibility of participating in a Self-directed SaeboFlex training program to allow repetitive task practice in patients early after stroke.
Subjects will undergo a 12-week training program comprising of a maximum of 3 x 45 minute sessions a day. Activities focus on grasping and releasing balls and reaching for targets, wearing the SaeboFlex for the majority of the session. At the end of each session the SaeboFlex is removed and the hand is incorporated into functional tasks as able. Subjects will be set individualized training program by a Saebo-trained therapist. The program will be graded and progressed at a rate that is appropriate to each individual.
The study will measure and follow-up 8 subjects to explore improvements in recovery and functional ability of the upper limb and affect on dependency levels. It will also explore the level of intensity patients early after stroke can tolerate and how they participate in self-directed therapy. All patients will meet the inclusion criteria and be motivated to undergo the specific SaeboFlex self-directed training program. Subjects will record the time and intensity of their training sessions and also their routine upper limb therapy. Patients will be assessed before, during and after the 3 months training. If these cases show promise the study will support the need for large trials including clinical efficacy and dose finding studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 8 individual case reviews | Experimental | Other: Self-directed Upper Limb SaeboFlex TrainingSaeboFlex Self-directed training |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Be either in-patients on Colchester Stroke Unit or,
- Out-patients following an acute stroke admission to Colchester Stroke Unit
- Be adults who have suffered a stroke between 3 and 84 days before recruitment
- Have an anterior circulation stroke - i.e. must have weakness not ataxia
- Have a substantially paretic hand and fingers and meet the criteria for the SaeboFlex orthosis as below
Key exclusion criteria (4 listed)
- Patients that are able to open and close his/her hand completely, 10 times keeping the wrist neutral while maintaining his / her maximum shoulder flexion are too good for the Saebo-flex. Other treatment options should be considered.
- Severe joint deformities that could be worsened by using an orthosis, i.e. RA
- Those patients with extremely poor skin integrity which may be cause irritation or skin damage.
- We will not exclude stroke survivors on the basis of age or gender but subjects will need to be motivated for self-directed study.
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 |
|---|---|---|
| Self-directed Upper Limb SaeboFlex TrainingParticipants undergo a 12 week self directed upper limb training programme with the SaeboFlex upper limb orthosis. Training consists of a maximum of 3 x 45 minute sessions a day. Participants are closely monitored at least once a week by a saebo-trained therapist. | Other | 8 individual case reviews |
Primary outcome
Action Research Arm Test (ARAT)
Time frame: Change from Baseline in upper limb function to 4, 8 and 12 weeks
Ability to use the paretic upper limb in functional activity. The ARAT is a test of upper limb function with subsections covering grasp, grip, pinch and gross movement. As the SaeboFlex is aimed at achieving grasp and release this measure appears very appropriate. It has good validity and reliability and is widely used in clinical research.
Motricity Index (MI)
Time frame: Change from Baseline in upper limb voluntary contraction to 4, 8 and 12 weeks
The Motricity Index (MI) is a clinical measure of the ability to voluntarily contract paretic muscle. It is an ordinal score with six levels of measurement within each of three categories for the upper limb (pinch grip, elbow flexion and shoulder abduction), has been used widely in clinical research, is valid, reliable and sensitive to change after stroke.
7 secondary outcomes
Motor Assessment Scale- Upper Limb Section (UL-MAS).
Time frame: Change from Baseline in upper limb function to 12 weeks
Visual Analogue Scale
Time frame: Change from Baseline to 12 weeks
Modified Barthel Index (MBI)
Time frame: Change from Baseline in Independence level to 4, 8 and 12 weeks
Stroke Impact Scale (SIS)
Time frame: Change from Baseline to 12 weeks
Berg Balance Test
Time frame: Change from Baseline in balance to 4, 8 and 12 weeks
Questionnaire
Time frame: 12 weeks
Adverse effects or events monitoring and recording
Time frame: throughout 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2011.
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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.
Rebecca Stuck, BSc principal investigator
Colchester Hospital University Foundation NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Self-directed Upper Limb SaeboFlex Training in people with Stroke, run by Colchester Hospital University NHS Foundation Trust at 1 site 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?
The sponsor lists 15 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: status not confirmed, as of the sponsor's last update on 17 Oct 2011. 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 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Stuck, BSc (01206 745912, rebecca.stuck@colchesterhospital.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Action Research Arm Test (ARAT) (time frame: Change from Baseline in upper limb function to 4, 8 and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Oct 2011.