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A pilot study to estimate the effect-size and possible selection criteria for dexamphetamine treatment during rehabilitation after acute stroke

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN56194158
Enrollment
Unknown
Registered
2003-09-12
Start date
2002-10-16
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular: Stroke Circulatory System

Interventions

This is a placebo-controlled, double-blind, randomised pilot study based within two rehabilitation stroke units. Eligible patients will be randomised to receive either dexamphetamine or placebo, with

Sponsors

Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All patients aged 18 years and over newly admitted to the stroke units in Bradford and Leeds will be assessed by a research assistant for potential recruitment. Eligible subjects will 1. have had a new stroke resulting in a right or left-sided weakness of sufficient severity to require an anticipated minimum 4-week stay on the stroke unit. 2, have a Computed Tomography (CT) scan to exclude intracranial haemorrhage 3. be medically stable and able to participate in daily rehabilitation.

Exclusion criteria

Exclusion criteria: 1. unable to understand language as a result of stroke 2. any memory impairment (pre-existing or as a consequence of the stroke) 3. stable heart disease and untreated high blood pressure 4. any psychiatric treatment within the past 5 years or a past history of drug or alcohol dependence.

Design outcomes

Primary

MeasureTime frame
The extent to which a subject's weakness has recovered at 3 months after the stroke. Interim assessments will occur at 3 and 6 weeks after beginning the trial medication. Assessment of recovery will document residual weakness of the affected arm, trunk and leg (using the Rivermead motor assessment scale) and the subject's degree of independence in basic activities of daily living (using the Barthel Index). In parallel, the subjects mood state will be assessed for depression and lack of motivation.

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026