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

Recruiting

Phase 1/2 Results N/A

Trial Description

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.

Conditions

Interventions

  • LifeCIT Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: LifeCIT
    Description: 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 Care Behavioral
    Intervention Desc: Participants will receive their usual care from their NHS provider.
    ARM 1: Kind: Experimental
    Label: Standard Care

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change from baseline to six months in upper limb activity: Motor Activity log Baseline, Post intervention, 6 months No
Secondary Change from baseline to six months in upper limb function: Wolf Motor Function Test Baseline, Post intervention, 6 months No
Secondary Change from baseline to six months in upper limb impairment: Fugl-Meyer Baseline, Post intervention, 6 months No
Secondary Change from baseline to six months in quality of life: Stroke Impact Scale Baseline, Post intervention, 6 months No
Secondary Change from baseline to six months in occupational performance: Canadian Occupational Performance Measure Baseline, Post intervention, 6 months No
Secondary Change from baseline to six months in quality of life: EQ5D Baseline, Post intervention, 6 months No
Secondary Change from baseline to six months of client use of resources: Client Service Receipt Inventory (CSRI) questionnaire Baseline, Post intervention, 6 months No

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