AIAS
Arm Intervention After Stroke: a feasibility study
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Purpose:
Is arm rehabilitaiton provided by the ArmeoSpring arm orthosis a feasible and acceptable intervention for acute stroke patients with arm deficits? Is arm rehabilitation provided by the ArmeoSpring arm orthosis, a safe intervention for acute stroke patients with arm deficits, compared with standard therapy? 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?
Interventions:
ArmeoSpring arm orthosis
to support functional therapy for patients who have lost the function of or have restricted function in their upper extremities caused by cerebral, neurogenic, spinal, muscular or bone-related disorders.
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Location(s):
United Kingdom
Year Started:
2009
Design:
Single-blind single-centre randomised feasibility/pilot study
Inclusion Criteria
Clinical diagnosis of stroke; minimum grade 1 on MRC scale for arm impairment; maximum grade 4 on MRC scale for arm impairment; medically stable; ability to understand and follow simple instructions; sitting balance sufficent to use Armeo arm orthosis safely.
Exclusion Criteria
Orthosis cannot be fitted to affected limb; bone instability of hemiparetic upper limb (fractures, severe arthritis);
pre-exisiting upper limb deficits; pronounced, fixed contractures of hemiparetic upper limb; open skin lesions on hemiparetic upper limb; major sensory deficit of hemiparetic upper limb; shoulder instability or excessive pain; severe spasticity; severe spontaneous movements e.g. ataxia, dyskinesia; confused or non-cooperative; requiring isolation due to infection; severe visual, perceptual or cognitive problems precluding participation in study protocol; involved in any other intervention study.
Patient Involvement:
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:
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:
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.
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Source of Information:
CurrentControlledTrials.com
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Web Links and Publications:
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This information last updated on: 10/16/2009
Reviewed on: 10/27/2009.
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