StrokePhase 1/2NCT01350453
Development and Pilot Evaluation of a Web-supported Programme of Constraint Induced Therapy Following Stroke (LifeCIT)
A Phase 1/2 study testing LifeCIT in people with Stroke, run by University of Southampton at 1 site in United Kingdom.
Trial summary
When a person has had a stroke they often lose their confidence, motivation and the ability to move one arm and hand. Recent research has shown that intensive exercise assists recovery of movement, but people are often discouraged by slow progress and stop using their weak limb. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- LifeCIT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2011to Dec 2014
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Clinical diagnosis of ischaemic or haemorrhagic stroke affecting either right or left upper limb
- Either: a) Able to transfer safely between toilet, chair and standing and able to walk safely at home wearing the C-MIT with or without the use of a walking aid or b) primarily a wheelchair user having help or supervision to transfer and walk
- Mini-mental score >23
- Minimum of 10 degrees of active wrist extension measured by a hand held goniometer
- Discharged home from hospital (not institutional care)
- Access to internet at home
Who cannot join
- Major medical problems that could interfere with participation
- Severe pain of the hemiparetic shoulder, arm or hand either at rest or during movement.
- People for whom communication problems prevent effective use of the system, will be excluded unless they have a carer who can support them effectively.
Trial locations and contacts
1 site in 1 country.
About this study
When a person has had a stroke they often lose their confidence, motivation and the ability to move one arm and hand. Recent research has shown that intensive exercise assists recovery of movement, but people are often discouraged by slow progress and stop using their weak limb.
A new idea, called Constraint Induced Therapy (CIT), has been shown to overcome this habitual 'non-use'. CIT involves wearing a mitt on the unaffected hand for several hours a day to prevent it from being used. Use of the weak arm and hand is encouraged by intensive exercises. CIT is not available in the NHS because of lack of therapist time for supervision and patients lack the confidence and motivation to carry out CIT alone at home.
Read more
This study will have two stages.
Stage 1.
The aim of this part of the study is to develop a web-based therapy programme ('LifeCIT') to support patients carrying out CIT at home (with their carer where possible) with online therapist support. The investigators will develop the therapy programme working closely with at least 12 patients, 6 carers and 6 therapists to identify and resolve any problems.
Stage 2
The investigators will then carry out a pilot trial in 6 treatment centers with 20 patients who have just been discharged from hospital and who have loss of arm and hand function. To test LifeCIT the investigators will randomly allocate patients to receive either the LifeCIT intervention or usual care. A researcher, who doesn't know which group patients have been allocated to, will measure their arm and hand function, record the problems this causes and how it affects their quality of life. Tests will be repeated after treatment (3 weeks) and 6 months later. The investigators will also examine the cost-effectiveness of treatment and ask both therapists and patients for their views.
Read the detailed description
Development and pilot evaluation of a web-supported programme of Constraint Induced Therapy following stroke (LifeCIT) PB-PG-0909-20145
Jane H. Burridge PhD1, Claire Meagher MSc1, Ann-Marie Hughes PhD1, Sean-Ewings PhD2, Ana-Carolina Gonçalves BSc1, Claudia H. S. Alt PhD1, Sebastien Pollet BSc1, Lucy Yardley PhD3
- Rehabilitation and Health Technologies Research Group, Faculty of Health Sciences, University of Southampton, United Kingdom.
- Faculty of Statistical Sciences, University of Southampton, United Kingdom.
- Faculty of Health Psychology, University of Southampton, United Kingdom.
Lay Summary
Background:
Following stroke people often lose their motivation and ability to move their hemiplegic arm. Intensive exercise assists recovery, but people often get into the habit of not using their arm.
Constraint-Induced Therapy (CIT) overcomes this habitual 'non-use'. CIT involves wearing a mitt on the unaffected hand to prevent it from being used. Use of the weak arm is encouraged by intensive exercises. CIT is not generally available in the NHS because of lack of therapist time to supervise the intensive exercises. We found that patients lack the confidence and motivation to carry out CIT alone at home.
We developed a web-based therapy programme ('LifeCIT') to support patients carrying out CIT at home with online therapy support. We developed LifeCIT working closely with patients, their carers and therapists. Their feedback and ideas ensured LifeCIT satisfied their needs. The first working version of LifeCIT was tested with 12 patients who had recently had a stroke and their feedback was used to make further improvements. A pilot trial with 19 patients tested whether LifeCIT affected recovery. We randomly allocated each patient to receive either 'LifeCIT' or 'usual care'. We tested patients before the study and repeated measurements after treatment (3 weeks) and 6 months later. We asked the patients who had used LifeCIT for their views on it - what was good and bad, and whether it had affected their ability to use their arm and hand.
Summary of research
Background:
Conventional therapy to improve upper limb function following stroke is not effective. <50% of people who survive a stroke but have moderate to severe hemiparesis regain upper limb function. Learnt non-use has been identified as an important factor in poor recovery. Constraint-Induced Therapy (CIT) [1; 2], proposes that constraint of the unaffected arm and hand, coupled with intensive training of the hemiplegic limb, leads to behavioral changes towards greater use of the hemiplegic limb, neuroplastic cortical changes and the return of function [3].
Despite evidence from a large RCT (n=222), which showed improvement in function maintained at 12 months post-treatment [4], CIT has not translated into clinical practice, due partly to the cost of intensive (minimum 4 hours/day for 10 days) one-to-one treatment. An alternative approach in which CIT was used at home without intensive therapy showed in an A-B-A trial, but patients reported lack of motivation to wear the C-MIT (Constraint Mitt) and comply with the exercise programme [5].
LifeGuide is a set of software resources to create and modify programmes of personalized online support for therapy, without the need for costly dedicated programming. It was used in this study to address the motivational barriers to home-based CIT.
Aims and Objectives:
- Working with patients, carers and therapists, create an accessible and engaging web-supported programme of CIT for home-based upper limb stroke rehabilitation - LifeCIT.
- Conduct a Phase II single-blinded RCT of LifeCIT to:
- Generate preliminary data on the effect size of the intervention compared with usual care for the purposes of calculating the power of a future phase III trial.
- Assess patients' views and adherence to the intervention and identify issues affecting the acceptability and feasibility of implementing and trialing the LifeCIT intervention.
Methods:
Phase 1. Intervention development:
The LifeCIT web-based programme for CIT combined with personalized activities, automated progress-relevant advice intervention content and format was co-designed with patients, carers and healthcare professionals. We held a series of meetings in which participants were shown mock-up webpages. Pages, structure, content, and activities were revised through a systematic response to feedback and then further revisions were made through in-depth think-aloud sessions with four chronic stroke patients.
During the development, process tape-recorded interviews and observational ('think aloud') studies [6-8] were used. Data collection and analysis was concurrent with intervention development, allowing immediate modification and re-testing of intervention components as potential improvements were identified.
The prototype web-based programme was then trialed with 12 sub-acute patients and their carers/ healthcare professionals and further revisions were made. The final version of the web-support programme was designed to:
- Provide personalized treatment protocols (including targets for C-MIT wearing, web-based repetitive and functional activities). The patient was encouraged to log-on each morning to plan a programme of C-MIT wearing and activities and to complete a set of repetitive exercises. They were asked to log-on again later in the day to report on adherence to the activities, any difficulties encountered, and to complete the second set of repetitive exercises.
- Provide structured support on progress and activities and automated support, based on activities and performance, including reminders (e.g. email or text messages to the patient and/or carer); motivational messages and suggestions for overcoming barriers.
Phase II Clinical trial:
A 6-center 3-week pilot trial compared usual care with LifeCIT. Computer block-randomization stratified into three ability groups. Participants randomized to the LifeCIT group were asked to wear the C-MIT for between 6 and 9 waking hours and aim for up to 6 hours activities per day on 5 days/week. A programme of activities was designed with them.
Participants Two cohorts of participants were recruited: One, sub-acute patients following discharge from hospital and one of the participants who had experienced a stroke more than 16 weeks previously.
- Conditions
- Stroke
- Being tested
- LifeCIT, Standard Care
- Keywords
- CIT, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifeCITBehavioural
Participants will be asked to aim to wear the C-MIT for 9 hours a day for 5 days/week, including 4-6 hours of structured activities per day: two 30-60 minute sessions of web-based activities and 3-4 hours practicing everyday activities.
Standard CareBehavioural
Participants will receive their usual care from their NHS provider.
| Study group | Role | What they receive |
|---|---|---|
| LifeCIT | Experimental | Participants will be asked to aim to wear the C-MIT for 9 hours a day for 5 days/week, including 4-6 hours of structured activities per day: two 30-60 minute sessions of web-based activities and 3-4 hours practicing everyday activities. Receives: Behavioral: LifeCIT |
| Standard Care | Active comparator | Participants received their usual care which included home exercises Receives: Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Upper Limb Impairment: Motor Activity Log (MAL) Amount of Use (AOU)
The MAL comprises 28 functional items, (e.g. picking up a glass; turning a key to open the door) each item is assessed by self-report on a six-point ordinal scale (0-5). Participants are asked to rate the amount of use of their hemiplegic arm for each item. Zero is scored if they have not used their affected arm, five is scored when they use their affected as often as before their stroke occurred. The final MAL score is calculated as a mean score of the individual items. The minimum and maximum mean scores are 0-5, with higher values representing better outcomes.
Measured: Baseline, Post intervention (three weeks) and 6 months
Change From Baseline in Upper Limb Impairment: Motor Activity Log (MAL) Quality of Use (QOU)
he MAL comprises 28 functional items, (e.g. picking up a glass; turning a key to open the door) each item is assessed by self-report on a six-point ordinal scale (0-5). Participants are asked to rate the quality of use of their hemiplegic arm for each item. Zero is scored if they can not use their affected arm, five is scored when they can use their affected arm as well as before their stroke occurred. The final MAL score is calculated as a mean score of the individual items. The minimum and maximum mean scores are 0-5, with higher values representing better outcomes.
Measured: Baseline, Post Intervention (three weeks) and 6 months
Secondary outcomes (3)
Change in Upper Limb Function: Wolf Motor Function Test (WMFT) Functional Ability Scale (FAS)
The modified WMFT is a valid, widely used measure that scores performance of activities of daily living in a controlled and structured environment he test has 17 items which test a range of functional upper limb tasks (for example turning a key in a lock, folding a towel, retrieving a weight). Each item is scored by the time taken to complete the task, the weight lifted or hand strength as measured by a hand held goniometer. Each item is subsequently scored on a rating scale 'The Functional Ability Scale' (FAS) from 0-5. Zero is scored if the participant does not attempt the task with their hemiplegic arm, and five is scored if the task is completed with a normal movement. The mean score of all items results with a mean FAS score.
Measured: Baseline, Post intervention (three weeks), 6 months
Change in Upper Limb Impairment: Fugel Myer Upper Extremity (FMUE)
The upper extremity domain of the Fugel Myer is a 0-66 point clinical assessed scale where separate Items are scored on a 3-point ordinal scale:
0 = cannot perform, 1 = performs partially, 2 = performs fully. A higher score indicates indicates an increased level of function.
Measured: Baseline, Post Intervention (three weeks) and 6 months
Change in Occupational Performance: Canadian Occupational Performance Measure Performance (COPM)
The Canadian Occupational Performance Measure (COPM) is an individualized client-centered measure designed for use by therapists to detect a change in a client's self-perception of occupational performance over time. The COPM involves a 5-step process within a semi-structured interview conducted by a therapist. The Interview focuses on identifying activities within each performance domain that the client wants, needs, or is expected to perform. They are then asked to rate their performance and satisfaction from 0-10 for each activity identified. A score of 0 indicates they are unable to perform the activity and a score of 10 means they can complete the activity. The same scoring system is used for the COPM Satisfaction assessment with scores ranging from 0-10 and higher scores indicating greater satisfaction.
Measured: Baseline, Post intervention (three weeks) and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, University Hospital Southampton NHS Foundation Trust, Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
- Responsible party
- Principal investigator, Jane Burridge, PhD, University of Southampton
- Investigators
- Jane Burridge, PhD, Principal investigator, Professor at University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350453
- Sponsor's protocol ID
- PB-PG-0909-20145
- Status last verified
- Feb 2019
- First submitted
- 6 May 2011
- Last updated
- 6 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Pilot Evaluation of a Web-supported Programme of Constraint Induced Therapy Following Stroke (LifeCIT)
- ClinicalTrials.gov ID
- NCT01350453
- Acronym / sponsor ID
- PB-PG-0909-20145
- Conditions
- Stroke
- Keywords
- CIT, Stroke
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, University Hospital Southampton NHS Foundation Trust, Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
- Study start
- May 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 May 2011 (estimated)
- Results
- Posted 6 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
When a person has had a stroke they often lose their confidence, motivation and the ability to move one arm and hand. Recent research has shown that intensive exercise assists recovery of movement, but people are often discouraged by slow progress and stop using their weak limb.
A new idea, called Constraint Induced Therapy (CIT), has been shown to overcome this habitual 'non-use'. CIT involves wearing a mitt on the unaffected hand for several hours a day to prevent it from being used. Use of the weak arm and hand is encouraged by intensive exercises. CIT is not available in the NHS because of lack of therapist time for supervision and patients lack the confidence and motivation to carry out CIT alone at home.
This study will have two stages.
Stage 1.
The aim of this part of the study is to develop a web-based therapy programme ('LifeCIT') to support patients carrying out CIT at home (with their carer where possible) with online therapist support. The investigators will develop the therapy programme working closely with at least 12 patients, 6 carers and 6 therapists to identify and resolve any problems.
Stage 2
The investigators will then carry out a pilot trial in 6 treatment centers with 20 patients who have just been discharged from hospital and who have loss of arm and hand function. To test LifeCIT the investigators will randomly allocate patients to receive either the LifeCIT intervention or usual care. A researcher, who doesn't know which group patients have been allocated to, will measure their arm and hand function, record the problems this causes and how it affects their quality of life. Tests will be repeated after treatment (3 weeks) and 6 months later. The investigators will also examine the cost-effectiveness of treatment and ask both therapists and patients for their views.
Detailed description
Development and pilot evaluation of a web-supported programme of Constraint Induced Therapy following stroke (LifeCIT) PB-PG-0909-20145
Jane H. Burridge PhD1, Claire Meagher MSc1, Ann-Marie Hughes PhD1, Sean-Ewings PhD2, Ana-Carolina Gonçalves BSc1, Claudia H. S. Alt PhD1, Sebastien Pollet BSc1, Lucy Yardley PhD3
- Rehabilitation and Health Technologies Research Group, Faculty of Health Sciences, University of Southampton, United Kingdom.
- Faculty of Statistical Sciences, University of Southampton, United Kingdom.
- Faculty of Health Psychology, University of Southampton, United Kingdom.
Lay Summary
Background:
Following stroke people often lose their motivation and ability to move their hemiplegic arm. Intensive exercise assists recovery, but people often get into the habit of not using their arm.
Constraint-Induced Therapy (CIT) overcomes this habitual 'non-use'. CIT involves wearing a mitt on the unaffected hand to prevent it from being used. Use of the weak arm is encouraged by intensive exercises. CIT is not generally available in the NHS because of lack of therapist time to supervise the intensive exercises. We found that patients lack the confidence and motivation to carry out CIT alone at home.
We developed a web-based therapy programme ('LifeCIT') to support patients carrying out CIT at home with online therapy support. We developed LifeCIT working closely with patients, their carers and therapists. Their feedback and ideas ensured LifeCIT satisfied their needs. The first working version of LifeCIT was tested with 12 patients who had recently had a stroke and their feedback was used to make further improvements. A pilot trial with 19 patients tested whether LifeCIT affected recovery. We randomly allocated each patient to receive either 'LifeCIT' or 'usual care'. We tested patients before the study and repeated measurements after treatment (3 weeks) and 6 months later. We asked the patients who had used LifeCIT for their views on it - what was good and bad, and whether it had affected their ability to use their arm and hand.
Summary of research
Background:
Conventional therapy to improve upper limb function following stroke is not effective. <50% of people who survive a stroke but have moderate to severe hemiparesis regain upper limb function. Learnt non-use has been identified as an important factor in poor recovery. Constraint-Induced Therapy (CIT) [1; 2], proposes that constraint of the unaffected arm and hand, coupled with intensive training of the hemiplegic limb, leads to behavioral changes towards greater use of the hemiplegic limb, neuroplastic cortical changes and the return of function [3].
Despite evidence from a large RCT (n=222), which showed improvement in function maintained at 12 months post-treatment [4], CIT has not translated into clinical practice, due partly to the cost of intensive (minimum 4 hours/day for 10 days) one-to-one treatment. An alternative approach in which CIT was used at home without intensive therapy showed in an A-B-A trial, but patients reported lack of motivation to wear the C-MIT (Constraint Mitt) and comply with the exercise programme [5].
LifeGuide is a set of software resources to create and modify programmes of personalized online support for therapy, without the need for costly dedicated programming. It was used in this study to address the motivational barriers to home-based CIT.
Aims and Objectives:
- Working with patients, carers and therapists, create an accessible and engaging web-supported programme of CIT for home-based upper limb stroke rehabilitation - LifeCIT.
- Conduct a Phase II single-blinded RCT of LifeCIT to:
- Generate preliminary data on the effect size of the intervention compared with usual care for the purposes of calculating the power of a future phase III trial.
- Assess patients' views and adherence to the intervention and identify issues affecting the acceptability and feasibility of implementing and trialing the LifeCIT intervention.
Methods:
Phase 1. Intervention development:
The LifeCIT web-based programme for CIT combined with personalized activities, automated progress-relevant advice intervention content and format was co-designed with patients, carers and healthcare professionals. We held a series of meetings in which participants were shown mock-up webpages. Pages, structure, content, and activities were revised through a systematic response to feedback and then further revisions were made through in-depth think-aloud sessions with four chronic stroke patients.
During the development, process tape-recorded interviews and observational ('think aloud') studies [6-8] were used. Data collection and analysis was concurrent with intervention development, allowing immediate modification and re-testing of intervention components as potential improvements were identified.
The prototype web-based programme was then trialed with 12 sub-acute patients and their carers/ healthcare professionals and further revisions were made. The final version of the web-support programme was designed to:
- Provide personalized treatment protocols (including targets for C-MIT wearing, web-based repetitive and functional activities). The patient was encouraged to log-on each morning to plan a programme of C-MIT wearing and activities and to complete a set of repetitive exercises. They were asked to log-on again later in the day to report on adherence to the activities, any difficulties encountered, and to complete the second set of repetitive exercises.
- Provide structured support on progress and activities and automated support, based on activities and performance, including reminders (e.g. email or text messages to the patient and/or carer); motivational messages and suggestions for overcoming barriers.
Phase II Clinical trial:
A 6-center 3-week pilot trial compared usual care with LifeCIT. Computer block-randomization stratified into three ability groups. Participants randomized to the LifeCIT group were asked to wear the C-MIT for between 6 and 9 waking hours and aim for up to 6 hours activities per day on 5 days/week. A programme of activities was designed with them.
Participants Two cohorts of participants were recruited: One, sub-acute patients following discharge from hospital and one of the participants who had experienced a stroke more than 16 weeks previously.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LifeCIT | Experimental | Behavioral: LifeCITParticipants will be asked to aim to wear the C-MIT for 9 hours a day for 5 days/week, including 4-6 hours of structured activities per day: two 30-60 minute sessions of web-based activities and 3-4 hours practicing everyday activities. |
| Standard Care | Active comparator | Behavioral: Standard CareParticipants received their usual care which included home exercises |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of ischaemic or haemorrhagic stroke affecting either right or left upper limb
- Either: a) Able to transfer safely between toilet, chair and standing and able to walk safely at home wearing the C-MIT with or without the use of a walking aid or b) primarily a wheelchair user having help or supervision to transfer and walk
- Mini-mental score >23
- Minimum of 10 degrees of active wrist extension measured by a hand held goniometer
- Discharged home from hospital (not institutional care)
Key exclusion criteria (3 listed)
- Major medical problems that could interfere with participation
- Severe pain of the hemiparetic shoulder, arm or hand either at rest or during movement.
- People for whom communication problems prevent effective use of the system, will be excluded unless they have a carer who can support them effectively.
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 |
|---|---|---|
| LifeCITParticipants will be asked to aim to wear the C-MIT for 9 hours a day for 5 days/week, including 4-6 hours of structured activities per day: two 30-60 minute sessions of web-based activities and 3-4 hours practicing everyday activities. | Behavioural | LifeCIT |
| Standard CareParticipants will receive their usual care from their NHS provider. | Behavioural | Standard Care |
Primary outcome
Change in Upper Limb Impairment: Motor Activity Log (MAL) Amount of Use (AOU)
Time frame: Baseline, Post intervention (three weeks) and 6 months
The MAL comprises 28 functional items, (e.g. picking up a glass; turning a key to open the door) each item is assessed by self-report on a six-point ordinal scale (0-5). Participants are asked to rate the amount of use of their hemiplegic arm for each item. Zero is scored if they have not used their affected arm, five is scored when they use their affected as often as before their stroke occurred. The final MAL score is calculated as a mean score of the individual items. The minimum and maximum mean scores are 0-5, with higher values representing better outcomes.
Change From Baseline in Upper Limb Impairment: Motor Activity Log (MAL) Quality of Use (QOU)
Time frame: Baseline, Post Intervention (three weeks) and 6 months
he MAL comprises 28 functional items, (e.g. picking up a glass; turning a key to open the door) each item is assessed by self-report on a six-point ordinal scale (0-5). Participants are asked to rate the quality of use of their hemiplegic arm for each item. Zero is scored if they can not use their affected arm, five is scored when they can use their affected arm as well as before their stroke occurred. The final MAL score is calculated as a mean score of the individual items. The minimum and maximum mean scores are 0-5, with higher values representing better outcomes.
3 secondary outcomes
Change in Upper Limb Function: Wolf Motor Function Test (WMFT) Functional Ability Scale (FAS)
Time frame: Baseline, Post intervention (three weeks), 6 months
Change in Upper Limb Impairment: Fugel Myer Upper Extremity (FMUE)
Time frame: Baseline, Post Intervention (three weeks) and 6 months
Change in Occupational Performance: Canadian Occupational Performance Measure Performance (COPM)
Time frame: Baseline, Post intervention (three weeks) and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jane Burridge, PhD principal investigator
Professor at University of Southampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LifeCIT in people with Stroke, run by University of Southampton 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 6 inclusion and 3 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 6 May 2019. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Upper Limb Impairment: Motor Activity Log (MAL) Amount of Use (AOU) (time frame: Baseline, Post intervention (three weeks) and 6 months). 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 6 May 2019; AzTrials last refreshed its copy on 29 Oct 2026.