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

NCT01656213 | Completed

• 1 other identifier: 12/LO/0087
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Conditions

Stroke; End Stage Renal Disease

Keywords

Stroke; End Stage Renal Disease; Recovery; Haemodialysis

Outcome Measures

Primary Outcomes (1)

• Upper-Extremity Fugl-Meyer scores

  sensitive measure of arm motor function

  3 months

Study Arms (2)

visual-feedback handgrip exercise

EXPERIMENTAL

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).

Control Arm

NO 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

Interventions

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

visual-feedback handgrip exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College NHS Trust

London, London, EC2Y 8BT, United Kingdom

Location

MeSH Terms

Conditions

Stroke; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mateusz pucek, M.D.

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2012
• First Posted: August 2, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: February 17, 2016

Record last verified: 2012-07

Locations

GB (1)