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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Imperial College London.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01656213
First received: July 11, 2012
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

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


Condition Intervention
Stroke
End Stage Renal Disease
Device: Computer-based target pursuit task (created using E-Prime software) and visual-feedback handgrip force transducer (CurrentDesigns 2012).

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Control Trial for Improving Functional Outcome From Stroke in End Stage Renal Disease Patients

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Upper-Extremity Fugl-Meyer scores [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    sensitive measure of arm motor function


Estimated Enrollment: 110
Study Start Date: July 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: visual-feedback handgrip exercise
Subjects allocated to treatment will be trained in the laptop-based exercise that takes 20 minutes/session. Subjects will be encouraged to perform the exercise 2-3 times per dialysis session
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.
No Intervention: Control Arm

60 similar ESRD stroke patients will be randomly assigned to the non-intervention arm. These patients will receive standard advice during dialysis (rest or gentle activity, e.g. reading).

Note that both groups of patients will also receive standard multidisciplinary rehabilitation care following a stroke, including therapy sessions at times other than receiving dialysis


Detailed Description:

Randomised Control Trial. ESRD patients on dialysis who have suffered an acute (<7 days) stroke (ischaemic/haemorrhagic) and predicted to have the worst likely outcome (see above) will be recruited for this RCT. Stroke patients will be randomly assigned to the intervention (60 patients) or standard treatment (60 patients) arms (power calculation below). Patients will have detailed demographic information documented. In addition, type, frequency and length of time on dialysis will be noted. Pre-/post- Upper-Extremity Fugl-Meyer scores will be undertaken (sensitive measure of arm motor function).

60 patients will be randomly allocated to the visual-feedback handgrip (affected arm) exercise that we have developed in-house (using Current Designs hand-grip force transducer, and E-Prime software). Subjects allocated to treatment will be trained in the laptop-based exercise that takes 20 minutes/session. 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.

Non-intervention. 60 similar ESRD stroke patients will be randomly assigned to the non-intervention arm. These patients will receive standard advice during dialysis (rest or gentle activity, e.g. reading).

Note that both groups of patients will also receive standard multidisciplinary rehabilitation care following a stroke, including therapy sessions at times other than receiving dialysis

3.1 STUDY OUTCOME MEASURES Primary outcome. 3 months change in Upper-Extremity Fugl-Meyer scores. Secondary outcome: 3 months changes in NIHS & Bartel scores

  • PARTICIPANT ENTRY

4.1 PRE-REGISTRATION EVALUATIONS We will recruit patients, who suffered from imaging proven, acute stroke affecting arm, while undergoing maintenance haemodialysis at the Imperial College NHS Trust as well as retrospectively analyse data of all patients with renal disease and stroke treated at Hammersmith Hospital

4.2 INCLUSION CRITERIA Patients with imaging proven, acute (<7days) stroke affecting arm, on maintenance dialysis will be recruited into the RCT. Patients have to be able to consent for the study either in writing, verbally or nonverbally in presence of a witness. We will retrospectively analyse the database of all renal disease patients with stroke. This data was collected by Hammersmith Hospital's Renal Team. In case of non-English speaking patients we will use Hospital's interpreter's services to explain the study to the patient, obtain their consent and train them in using the device. .

4.3 EXCLUSION CRITERIA Patients unwilling to give consent, patients unable to use hand grip tool due to severe hand weakness (MRC 0/5), patients unable to understand English or their native language due to receptive aphasia, dementia. Patients with arteriovenous fistula in the affected arm will be excluded from the trial

4.4 WITHDRAWAL CRITERIA Patients unwilling to further participate in the study. Patients, who lose capacity to consent during the study. Patient experiencing side effects. In these cases the data collected will be used for final analysis but no new data will be collected.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with imaging proven, acute (<7days) stroke affecting arm, on maintenance dialysis will be recruited into the RCT. Patients have to be able to consent for the study either in writing, verbally or nonverbally in presence of a witness. We will retrospectively analyse the database of all renal disease patients with stroke. This data was collected by Hammersmith Hospital's Renal Team. In case of non-English speaking patients we will use Hospital's interpreter's services to explain the study to the patient, obtain their consent and train them in using the device

Exclusion Criteria:

  • Patients unwilling to give consent, patients unable to use hand grip tool due to severe hand weakness (MRC 0/5), patients unable to understand English or their native language due to receptive aphasia, dementia. Patients with arteriovenous fistula in the affected arm will be excluded from the trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01656213

Contacts
Contact: Mateusz Pucek, M.D. +44 07719397244

Locations
United Kingdom
Imperial College NHS Trust Not yet recruiting
London, United Kingdom, EC2Y 8BT
Contact: Mateusz Pucel       m.pucek11@imperial.ac.uk   
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Mateusz pucek, M.D. Imperial College London
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01656213     History of Changes
Other Study ID Numbers: 12/LO/0087
Study First Received: July 11, 2012
Last Updated: July 31, 2012
Health Authority: United Kingdom: Imperial College London

Keywords provided by Imperial College London:
Stroke
End Stage Renal Disease
Recovery
Haemodialysis

Additional relevant MeSH terms:
Kidney Failure, Chronic
Cerebral Infarction
Kidney Diseases
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014