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

NCT ID: NCT01656213

Last Updated: 2016-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2014-07-31

Brief 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

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.

Conditions

Stroke; End Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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.

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mateusz pucek, M.D.

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

Imperial College NHS Trust

London, London, United Kingdom

Countries

United Kingdom

Other Identifiers

12/LO/0087

Identifier Type: -

Identifier Source: org_study_id