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Development and Pilot Evaluation of a Web-supported Programme of Constraint Induced Therapy Following Stroke (LifeCIT)

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ClinicalTrials.gov Identifier: NCT01350453
Recruitment Status : Completed
First Posted : May 9, 2011
Results First Posted : May 6, 2019
Last Update Posted : May 6, 2019
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
University Hospital Southampton NHS Foundation Trust
Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
Jane Burridge, PhD, University of Southampton

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Stroke Behavioral: LifeCIT Behavioral: Standard Care Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Development and Pilot Evaluation of a Web-supported Programme of Constraint Induced Therapy Following Stroke (LifeCIT)
Study Start Date : May 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: LifeCIT
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.
Behavioral: LifeCIT
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.

Active Comparator: Standard Care
Participants received their usual care which included home exercises
Behavioral: Standard Care
Participants will receive their usual care from their NHS provider.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Change in Upper Limb Function: Wolf Motor Function Test (WMFT) Functional Ability Scale (FAS) [ Time Frame: Baseline, Post intervention (three weeks), 6 months ]
    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.

  2. Change in Upper Limb Impairment: Fugel Myer Upper Extremity (FMUE) [ Time Frame: Baseline, Post Intervention (three weeks) and 6 months ]

    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.


  3. Change in Occupational Performance: Canadian Occupational Performance Measure Performance (COPM) [ Time Frame: Baseline, Post intervention (three weeks) and 6 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01350453


Locations
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United Kingdom
University of Southampton
Southampton, United Kingdom
Sponsors and Collaborators
University of Southampton
National Institute for Health Research, United Kingdom
University Hospital Southampton NHS Foundation Trust
Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Jane Burridge, PhD Professor at University of Southampton

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Responsible Party: Jane Burridge, PhD, Professor, University of Southampton
ClinicalTrials.gov Identifier: NCT01350453     History of Changes
Other Study ID Numbers: PB-PG-0909-20145
First Posted: May 9, 2011    Key Record Dates
Results First Posted: May 6, 2019
Last Update Posted: May 6, 2019
Last Verified: February 2019
Keywords provided by Jane Burridge, PhD, University of Southampton:
CIT
Stroke
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases