Early electrical stimulation to the wrist extensors and wrist flexors to prevent the post-stroke complications of pain and contractures in the paretic arm

Not Applicable

Completed

• Conditions: Topic: Stroke; Subtopic: Rehabilitation; Disease: Therapy type; Circulatory System

• Registration Number: ISRCTN16489086
• Lead Sponsor: niversity of Nottingham

Brief Summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26729394

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-15
• Study Completion: 2018-03-31
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Eligibility criteria – patient participants for the feasibility RCT
1. Patients with a confirmed clinical diagnosis of stroke AND it is their first stroke event to affect their upper limb
2. Patients aged 18 years or over
3. Impaired arm movement and strength resulting in reduced function, caused specifically by the stroke. (as determined by the arm subsection score of the National Institute for Health Stroke Scale (NIHSS)

Carer participants for the feasibility RCT Inclusion criteria
1. Nominated carer for a patient participating in the feasibility RCT
Eligibility criteria – Patient and carer interviews
1. Participating in the main feasibility RCT
2. Mental capacity to consent and take part in the interview
3. Able to understand English
4. Nominated carer supporting a participant in the main feasibility RCT
5. Mental capacity to consent and take part in the interview
6. Able to understand English

Therapist Focus Discussion Groups
1. HCPC registered occupational therapist or physiotherapist
2. Currently employed by NUH NHS Trust and working on the Nottingham Stroke Unit
3. Experience of supporting at least one participant to use the ES intervention

Exclusion Criteria

Patient participants for the feasibility RCT
1. Patients with a previous history of stroke affecting their upper limb will be excluded as a chronic limb condition from a previous stroke could affect the results
2. Patients will also be excluded with peripheral nerve injury of the upper limb; an existing orthopaedic condition affecting the upper limb; fixed contractures at the elbow, wrist or fingers; malignancy in the area of the ES electrode placement; or epilepsy
3. Patients with a cardiac pacemaker or similar implanted device.
4. Pregnancy
5. Undiagnosed pain or skin conditions (i.e. not related to the stroke)

Carer participants for the feasibility RCT
1. Non English speaking

Patient and carer interviews
Patient
1. Individual is unable to communicate verbally or in written form
2. NonEnglish speaking
3. Aged younger than 18 years
Carer
1. Individual is unable to communicate verbally or in written form
2. NonEnglish speaking
3. Aged younger than 18 years

Study & Design

• Study Type: Interventional
• Study Design: Not specified