Arm Intervention After Stroke (AIAS): a feasibility study

ISRCTN	ISRCTN33421390
DOI	https://doi.org/10.1186/ISRCTN33421390
Protocol serial number	GN09GE229 (Ethics no: 09/S0704/32)
Sponsor	NHS Greater Glasgow and Clyde (UK)
Funder	Chief Scientist Office of the Scottish Executive Health Department (UK) (ref: CZF/07/12)

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 of protocol

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

Primary study design	Interventional
Study design	Single-blind single-centre randomised feasibility/pilot study
Secondary study design	Randomised controlled trial
Study type	Participant 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 objectives	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
Health condition(s) or problem(s) studied	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(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
Key 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.
Completion date	04/04/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	18
Key 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
Key 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
Date of first enrolment	03/08/2009
Date of final enrolment	04/04/2010

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

Academic Section of Geriatric Medicine

Glasgow
G31 2ER
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

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