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

NCT01350453 | Completed Phase 1 Results

• 1 other identifier: PB-PG-0909-20145
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

CIT; Stroke

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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)

  Baseline, Post intervention (three weeks), 6 months

• Change in Upper Limb Impairment: Fugel Myer Upper Extremity (FMUE)

  Baseline, Post Intervention (three weeks) and 6 months

• Change in Occupational Performance: Canadian Occupational Performance Measure Performance (COPM)

  Baseline, Post intervention (three weeks) and 6 months

Study Arms (2)

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.

Behavioral: LifeCIT

Standard Care

ACTIVE COMPARATOR

Participants received their usual care which included home exercises

Behavioral: Standard Care

Interventions

LifeCIT BEHAVIORAL

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.

LifeCIT

Standard Care BEHAVIORAL

Participants will receive their usual care from their NHS provider.

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southampton: lead
• National Institute for Health Research, United Kingdom: collaborator
• University Hospital Southampton NHS Foundation Trust: collaborator
• Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

University of Southampton

Southampton, United Kingdom

Location

MeSH Terms

Conditions

Stroke

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Jane Burridge
• Organization: University of Southampton

jhb1@soton.ac.uk

+44(0)2380 598 885

Study Officials

• Jane Burridge, PhD

  Professor at University of Southampton

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 6, 2011
• First Posted: May 9, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 6, 2019
• Results First Posted: May 6, 2019

Record last verified: 2019-02

Locations

GB (1)