Changes in bone structure, lean mass, and glucose metabolism after stroke: a prospective study

Not Applicable

Recruiting

• Conditions: Acute Stroke; bone structure and density; glucose metabolism; Stroke - Ischaemic; Stroke - Haemorrhagic

• Registration Number: ACTRN12612000123842
• Lead Sponsor: Florey Neuroscience Institutes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

The inclusion criteria are (1) a diagnosis of hemispheric stroke , (2) onset of stroke <1 week, (3) medically stable, (4) unable to ambulate within the first week after stroke, (5) able to understand simple verbal commands.

Exclusion Criteria

(1) brainstem or cerebellar stroke, (2) previous stroke in addition to the current admission, (3) known type 1 or type 2 diabetes (4) neurological conditions other than stroke (e.g. Parkinson’s disease) (5) significant musculoskeletal condition impacting on function (e.g. amputation, severe arthritis), (6) current or recent use of bone resorption inhibitors

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone structure and volumetric bone mineral density of paretic and non-paretic side radius and tibia, measured by high resolution peripheral quantitative computed tomography (pQCT)[Baseline (within 2 weeks of stroke), 6-, 12-,18- and 24 months];Body composition: total body and regional bone mineral density and fat/ muscle mass measured by dual-energy xray absorptiometry (DXA)[Baseline, 1-, 3-, 6-, 12-, 18- and 24- months]

Secondary Outcome Measures

Name	Time	Method
Glucose tolerance measured by two hour oral glucose tolerance test[Baseline, 6-, 12-,18- and 24 months];Physical activity monitoring (PAL2 accelerometer)[Baseline, 1-, 3-, 6-, 12-, 18- and 24- months];Blood markers of bone resorption and formation, including osteocalcin, C-telopeptide (CTX), pro-collagen type 1 n-terminal propeptide (PINP)[Baseline, 1-, 3-, 6-, 12-, 18- and 24- months];Physical assessment of muscle strength (hand held dynamometry), muscle tone (modified ashworth scale, motor control (Chedoke McMaster Stroke Assessment ), arm use (Motor Activity Log), walking ability (Functional Ambulation Category)[Baseline, 1-, 3-, 6-, 12-, 18- and 24- months]