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

This study is currently recruiting participants.
Verified August 2012 by University of Southampton
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
ClinicalTrials.gov Identifier:
NCT01350453
First received: May 6, 2011
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

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 three centres with 40-60 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 Intervention Phase
Stroke
Behavioral: LifeCIT
Behavioral: Standard Care
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Development and Pilot Evaluation of a Web-supported Programme of Constraint Induced Therapy Following Stroke (LifeCIT)

Resource links provided by NLM:


Further study details as provided by University of Southampton:

Primary Outcome Measures:
  • Change from baseline to six months in upper limb activity: Motor Activity log [ Time Frame: Baseline, Post intervention, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline to six months in upper limb function: Wolf Motor Function Test [ Time Frame: Baseline, Post intervention, 6 months ] [ Designated as safety issue: No ]
  • Change from baseline to six months in upper limb impairment: Fugl-Meyer [ Time Frame: Baseline, Post intervention, 6 months ] [ Designated as safety issue: No ]
  • Change from baseline to six months in quality of life: Stroke Impact Scale [ Time Frame: Baseline, Post intervention, 6 months ] [ Designated as safety issue: No ]
  • Change from baseline to six months in occupational performance: Canadian Occupational Performance Measure [ Time Frame: Baseline, Post intervention, 6 months ] [ Designated as safety issue: No ]
  • Change from baseline to six months in quality of life: EQ5D [ Time Frame: Baseline, Post intervention, 6 months ] [ Designated as safety issue: No ]
  • Change from baseline to six months of client use of resources: Client Service Receipt Inventory (CSRI) questionnaire [ Time Frame: Baseline, Post intervention, 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Behavioral: Standard Care
Participants will receive their usual care from their NHS provider.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • First ischaemic or haemorrhagic stroke (Confirmed by CT/MRI) 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01350453

Contacts
Contact: Claire Meagher, MSc 02380595305 cm3v08@soton.ac.uk

Locations
United Kingdom
University of Southampton Recruiting
Southampton, United Kingdom
Principal Investigator: Jane Burridge, PhD         
Sub-Investigator: Lucy Yardley, PhD         
Sub-Investigator: Ann Marie Hughes, PhD         
Sub-Investigator: Claire Meagher, Msc         
Sub-Investigator: Sebastien Pollet, BSc         
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
Principal Investigator: Jane Burridge, PhD Professor at University of Southampton
  More Information

No publications provided

Responsible Party: Jane Burridge, PhD, Professor, University of Southampton
ClinicalTrials.gov Identifier: NCT01350453     History of Changes
Other Study ID Numbers: PB-PG-0909-20145
Study First Received: May 6, 2011
Last Updated: August 1, 2012
Health Authority: United Kingdom: National Institute for Health Research

Keywords provided by University of Southampton:
CIT
Stroke

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on April 16, 2014