Does early targeted trunk training improve mobility outcome at 6 months for patients who are unable to sit unsupported at admission?

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 20

Inclusion Criteria

Inclusion criteria (updated on 19/09/2016):
1. Aged 18 years or over
2. Between day 3 and day 7 of a supra tentorial lesion associated with an ischaemic or haemorrhagic stroke
3. With hemiparesis involving the arm and leg
4. Able to understand and follow a one-stage command
5. With significant trunk deficit evidenced by an inability to sit independently for 30 seconds
6. Able to provide informed consent in accordance with the Mental Capacity Act (2005)
7. Patients with mild aphasia can be included, the consent procedure will be facilitated using pictorial aphasia-friendly participant information booklets and communication other than spoken language (for example, gestures, strategic use of environmental cues) in line with Connect recommendations
8. Non-English speakers will be included if the aid of an interpreter is available via the NHS

Sub-study:
1. Those meeting inclusion criteria (above)
2. Lacking mental capacity to give informed consent

Original inclusion criteria:
1. Aged 18 years or over
2. Between day 3 and day 7 of a first supra tentorial lesion associated with an ischaemic or haemorrhagic stroke
3. With hemiparesis involving the arm and leg
4. Able to understand and follow a two-stage command
5. With significant trunk deficit evidenced by an inability to sit independently for 30 seconds
6. Able to provide informed consent in accordance with the Mental Capacity Act (2005)
7. Patients with mild aphasia can be included, the consent procedure will be facilitated using pictorial aphasia-friendly participant information booklets and communication other than spoken language (for example, gestures, strategic use of environmental cues) in line with Connect recommendations
8. Non-English speakers will be included if the aid of an interpreter is available via the NHS

Exclusion Criteria

Exclusion criteria (updated on 19/09/2016):
1. Individuals with brainstem or cerebellar strokes associated with severe symptoms of dizziness or positional vertigo exacerbated by exercise. Screening for severe dizziness will be ascertained by the medical staff before recruiting.
2. Clinically significant pre-morbid levels of disability
3. Not medically stable as defined by the medical team

Original exclusion criteria:
1. Individuals with brain stem, cerebellar or multiple stroke lesion
2. Previous neurological disease affecting motor performance
3. Not medically stable

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility measures of recruitment, retention and attrition will be determined through screening and completion data to measure the number of admitted patients that fulfil the study inclusion/exclusion criteria; consent to take part in the study; complete the trunk training intervention; and complete baseline, post intervention and 6 month follow up assessments of the secondary outcome measures.

Secondary Outcome Measures

Name	Time	Method
1. Trunk impairment is measured using the Trunk Impairment Scale at baseline, post intervention and at 6 months follow-up<br>2. Mobility is measured using the Modified Rivermead Mobility Index at baseline, post intervention and at 6 months follow-up<br>3. Quality of life is measured using the Stroke Specific Quality of Life Scale and SF-6D at baseline, post intervention and at 6 months follow-up<br>4. Quality of life and health costs (QALYs) are measured using the EQ5D-5L at baseline, post intervention and at 6 months follow-up