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| [ ...Back to search results ] | [ Print-friendly version ] |
| Arm Intervention After Stroke (AIAS): a feasibility study |
| ISRCTN | ISRCTN33421390 |
| ClinicalTrials.gov identifier | |
| Public title | Arm Intervention After Stroke (AIAS): a feasibility study |
| Scientific title | A randomised, feasibility, safety and efficacy of the ArmeoSpring arm orthosis for acute stroke patients with arm deficits |
| Acronym | AIAS |
| Serial number at source | GN09GE229 (Ethics no: 09/S0704/32) |
| Study hypothesis |
Arm rehabilitation provided by the ArmeoSpring is a feasible and acceptable intervention to implement with acute stroke patients with arm deficits.
Principal research question: Is arm rehabilitaiton provided by the ArmeoSpring arm orthosis a feasible and acceptable intervention for acute stroke patients with arm deficits? Secondary research questions: 1. Is arm rehabilitation provided by the ArmeoSpring arm orthosis, a safe intervention for acute stroke patients with arm deficits, compared with standard therapy? 2. What are the effects of two different intenstities of arm rehabilitaiton provided by the ArmeoSpring arm orthosis for acute stroke patients with arm deficits, compared with standard therapy? |
| Ethics approval | West of Scotland (REC 4) Ethics Committee approved on the 12th June 2009 (ref: 09/S0704/32) |
| Study design | Single-blind single-centre randomised feasibility/pilot study |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Acute stroke |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 03/08/2009 |
| Anticipated end date | 04/04/2010 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 18 |
| Interventions |
The participants will be randomly allocated to one of the three following arms:
1. Standard care: usual therapy, provided by physiotherapists and occupational therapists 2. ArmeoSpring arm orthosis intervention 1: 40 minutes, 3 times a week, in addition to standard care 3. ArmeoSpring arm orthosis intervention 2: 60 minutes, 5 times a week, in addition to standard care Total duration of interventions: 2 weeks or discharge (whichever is sooner) Total duration of follow-up: 3 months ArmeoSpring intervention will be delievered by a research therapist. |
| Primary outcome measure(s) |
1. Feasibility of experimental interventions:
1.1. Number of per protocol interventions recorded at end of intervention period 1.2. Reasons for non-compliance recorded at end of intervention period 2. Acceptability/satisfaction of experimental intervention: informal interviews with participants completed at the end of the intervention period |
| Secondary outcome measure(s) |
Safety outcomes:
1. Arm pain (including shoulder) (measured by 5 point scale none-excruciating) 2. Shoulder subluxation (clinical report) 3. Fatigue (Borg perceived Exertion Scale) 4. All adverse events 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). Efficacy outcomes: 1. Upper limb function: Action Research Arm Test 2. Upper limb impairment: Fugl-Meyer assessment (upper limb section) 3. Disability: Barthel Index Exploratory outcome: To assist in power calculation to determine the number of subjects required for a phase III randomised controlled trial. |
| Sources of funding | Chief Scientist Office of the Scottish Executive Health Department (UK) (ref: CZF/07/12) |
| Trial website | |
| Publications | |
| Contact name | Mrs Fiona Coupar |
| Address |
Academic Section of Geriatric Medicine
Room 35, Level 4 University Block Glasgow Royal Infirmary |
| City/town | Glasgow |
| Zip/Postcode | G31 2ER |
| Country | United Kingdom |
| fmacvicar@yahoo.com | |
| Sponsor | NHS Greater Glasgow and Clyde (UK) |
| Address |
Tennant Institute
38 Church Street Western Infirmary |
| City/town | Glasgow |
| Zip/Postcode | G11 6NT |
| Country | United Kingdom |
| darrengibson@ggc.scot.nhs.uk | |
| Sponsor website: | http://www.nhsggc.org.uk |
| Date applied | 07/07/2009 |
| Last edited | 03/09/2009 |
| Date ISRCTN assigned | 03/09/2009 |
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