Phase 2
Completed N=19
Development and Pilot Evaluation of a Web-supported Programme of Constraint Induced Therapy Following Stroke (LifeCIT)
Source: ClinicalTrials.gov NCT01350453 ↗Enrolled (actual)
19
Serious AEs
10.5%
Results posted
May 2019
Primary outcomePrimary: Change in Upper Limb Impairment: Motor Activity Log (MAL) Amount of Use (AOU) — 1.02; 0.06; 0.60; 0.29 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Upper Limb Impairment: Motor Activity Log (MAL) Amount of Use (AOU) |
1.02; 0.06; 0.60; 0.29 | — |
| PRIMARY Change From Baseline in Upper Limb Impairment: Motor Activity Log (MAL) Quality of Use (QOU) |
1.02; 0.26; 0.6; 0.23 | — |
| SECONDARY Change in Upper Limb Function: Wolf Motor Function Test (WMFT) Functional Ability Scale (FAS) |
0.35; 0.02; 0.30; 0.01 | — |
| SECONDARY Change in Upper Limb Impairment: Fugel Myer Upper Extremity (FMUE) |
5.67; 2.29; 5.29; 4.00 | — |
| SECONDARY Change in Occupational Performance: Canadian Occupational Performance Measure Performance (COPM) |
1.07; 0.77; 1.69; 1.24; 1.27; 1.34 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01350453). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.