Condition category
Circulatory System
Date applied
07/07/2009
Date assigned
03/09/2009
Last edited
15/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Fiona Coupar

ORCID ID

Contact details

Academic Section of Geriatric Medicine
Room 35
Level 4
University Block
Glasgow Royal Infirmary
Glasgow
G31 2ER
United Kingdom
+44 141 211 4000
fmacvicar@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

GN09GE229 (Ethics no: 09/S0704/32)

Study information

Scientific title

A randomised, feasibility, safety and efficacy of the ArmeoSpring arm orthosis for acute stroke patients with arm deficits

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

West of Scotland (REC 4) Ethics Committee, 12/06/2009, ref: 09/S0704/32

Study design

Single-blind single-centre randomised feasibility/pilot study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

03/08/2009

Overall trial end date

04/04/2010

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

18

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

United Kingdom

Trial participating centre

Academic Section of Geriatric Medicine
Glasgow
G31 2ER
United Kingdom

Sponsor information

Organisation

NHS Greater Glasgow and Clyde (UK)

Sponsor details

Tennant Institute
38 Church Street
Western Infirmary
Glasgow
G11 6NT
United Kingdom
+44 141 354 9275
darrengibson@ggc.scot.nhs.uk

Sponsor type

Government

Website

http://www.nhsggc.org.uk

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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