Arm Intervention After Stroke (AIAS): a feasibility study

ISRCTN	ISRCTN33421390
DOI	https://doi.org/10.1186/ISRCTN33421390
Secondary identifying numbers	GN09GE229 (Ethics no: 09/S0704/32)

Submission date: 07/07/2009
Registration date: 03/09/2009
Last edited: 15/07/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Not provided at time of registration

Contact information

Mrs Fiona Coupar
Scientific

Academic Section of Geriatric Medicine
Room 35, Level 4
University Block
Glasgow Royal Infirmary
Glasgow
G31 2ER
United Kingdom

Phone	+44 141 211 4000
Email	fmacvicar@yahoo.com

Study information

Study design	Single-blind single-centre randomised feasibility/pilot study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A randomised, feasibility, safety and efficacy of the ArmeoSpring arm orthosis for acute stroke patients with arm deficits
Study acronym	AIAS
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(s)	West of Scotland (REC 4) Ethics Committee, 12/06/2009, ref: 09/S0704/32
Condition	Acute stroke
Intervention	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.
Intervention type	Other
Primary outcome measure	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 measures	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.
Overall study start date	03/08/2009
Overall study end date	04/04/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	18
Participant 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
Participant 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
Recruitment start date	03/08/2009
Recruitment end date	04/04/2010

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

Academic Section of Geriatric Medicine

Glasgow
G31 2ER
United Kingdom

Sponsor information

NHS Greater Glasgow and Clyde (UK)
Government

Tennant Institute
38 Church Street
Western Infirmary
Glasgow
G11 6NT
United Kingdom

Phone	+44 141 354 9275
Email	darrengibson@ggc.scot.nhs.uk
Website	http://www.nhsggc.org.uk
"ROR"	https://ror.org/05kdz4d87

Funders

Funder type

Government

Chief Scientist Office of the Scottish Executive Health Department (UK) (ref: CZF/07/12)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

15/07/2016: No publications found, verifying study status with principal investigator.