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

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

Study Overview

• Status: Completed
• Conditions: Stroke; End Stage Renal Disease
• Intervention / Treatment: Device: Computer-based target pursuit task (created using E-Prime software) and visual-feedback handgrip force transducer (CurrentDesigns 2012).

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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, EC2Y 8BT
    • Imperial College NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper-Extremity Fugl-Meyer scores	sensitive measure of arm motor function	3 months

Collaborators and Investigators

• Sponsor: Imperial College London
• Investigators: Principal Investigator: Mateusz pucek, M.D., Imperial College London

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: July 11, 2012
• First Submitted That Met QC Criteria: July 31, 2012
• First Posted (Estimate): August 2, 2012

Study Record Updates

• Last Update Posted (Estimate): February 17, 2016
• Last Update Submitted That Met QC Criteria: February 15, 2016
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Stroke; End Stage Renal Disease; Recovery; Haemodialysis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Stroke; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: 12/LO/0087