Arm Intervention After Stroke (AIAS): a feasibility study

Not Applicable

Completed

Conditions: Acute stroke
Circulatory System
Stroke, not specified as haemorrhage or infarction

Registration Number: ISRCTN33421390

Lead Sponsor: HS Greater Glasgow and Clyde (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 18

Inclusion Criteria

1. Age greater than 18 years, either sex
2. Clinical diagnosis of stroke
3. Minimum grade 1 on MRC scale for arm impairment
4. Maximum grade 4 on MRC scale for arm impairment
5. Medically stable
6. Informed consent
7. Ability to understand and follow simple instructions
8. Sitting balance sufficent to use Armeo arm orthosis safely

Exclusion Criteria

1. Orthosis cannot be fitted to affected limb
2. Bone instability of hemiparetic upper limb (fractures, severe arthritis)
3. Pre-exisiting upper limb deficits
4. Pronounced, fixed contractures of hemiparetic upper limb
5. Open skin lesions on hemiparetic upper limb
6. Major sensory deficit of hemiparetic upper limb
7. Shoulder instability or excessive pain
8. Severe spasticity
9. Severe spontaneous movements e.g. ataxia, dyskinesia
10. Confused or non-cooperative
11. Requiring isolation due to infection
12. Severe visual, perceptual or cognitive problems precluding participation in study protocol
13. Involved in any other intervention study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Feasibility of experimental interventions: <br>1.1. Number of per protocol interventions recorded at end of intervention period<br>1.2. Reasons for non-compliance recorded at end of intervention period<br>2. Acceptability/satisfaction of experimental intervention: informal interviews with participants completed at the end of the intervention period

Secondary Outcome Measures

Name	Time	Method
Safety outcomes: <br>1. Arm pain (including shoulder) (measured by 5 point scale none-excruciating)<br>2. Shoulder subluxation (clinical report)<br>3. Fatigue (Borg perceived Exertion Scale)<br>4. All adverse events<br>Safety outcomes will be continously monitored and recorded throughout the study, however will be formally recorded at the end of the intervention period (2 weeks or discharge) (by clinical report and patient scales) and at 3 month report (by patient report and scales, on appropriate measures).<br><br>Efficacy outcomes:<br>1. Upper limb function: Action Research Arm Test<br>2. Upper limb impairment: Fugl-Meyer assessment (upper limb section)<br>3. Disability: Barthel Index<br><br>Exploratory outcome: <br>To assist in power calculation to determine the number of subjects required for a phase III randomised controlled trial.