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Randomised Control Trial for Improving Functional Outcome From Stroke in End Stage Renal Disease Patients

NCT01656213 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2016-02-17

No results posted yet for this study

Summary

TITLE Randomised Control Trial (RCT) for improving functional outcome from stroke in renal disease patients DESIGN Eandomised Conrol Study AIMS

1. Undertake detailed characterisation of stroke (including recently developed imaging techniques at Imperial) of stroke in renal disease patients including clinical, imaging and epidemiological data
2. To Investigate if passive intervention using hand grip device during dialysis sessions will improve functional outcome from stroke in end stage renal disease patients.

OUTCOME MEASURES

1. Primary outcome:. 3 months change in Upper-Extremity Fugl-Meyer scores.
2. Secondary outcome: 3 months change in NIHS \& Bartel scores

POPULATION Ischaemic and haemorrhagic stroke patients with renal disease treated at Hammersmith's Hospital's renal Unit. .

ELIGIBILITY Data of all patients with renal disease and imaging proven stroke will be retrospectively analysed. RCT will be conducted on End Stage Renal Disease patients with acute (\<7 days) stroke affecting arm.

DURATION 2 years

Conditions

Interventions

DEVICE

Computer-based target pursuit task (created using E-Prime software) and visual-feedback handgrip force transducer (CurrentDesigns 2012).

Subjects will be encouraged to perform the exercise 2-3 times per dialysis session depending upon mood, although will be permitted to skip sessions if they do not feel well or motivated. The laptop program time-stamps each session, and records a time-series of duration, force and accuracy of hand grip.

Sponsors & Collaborators

  • Imperial College London

    lead OTHER

Principal Investigators

  • Mateusz pucek, M.D. · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01656213 on ClinicalTrials.gov