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

• Register: ISRCTN
• Last refreshed on: 26 August 2019
• Main ID: ISRCTN16489086
• Date of registration: 15/01/2015
• Prospective Registration: Yes
• Primary sponsor: University of Nottingham
• Public title: Early electrical stimulation to the wrist extensors and wrist flexors to prevent the post-stroke complications of pain and contractures in the paretic arm
• Scientific title: Early electrical stimulation to the wrist extensors and wrist flexors to prevent the post-stroke complications of pain and contractures in the paretic arm - a feasibility study
• Date of first enrolment: 01/05/2015
• Target sample size: 40
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN16489086
• Study type: Interventional
• Study design: Randomised; Interventional (Treatment)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Joanna Fletcher-Smith

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

1. Feasibility RCT:
Participants will be randomly allocated to one of two groups: intervention or control.

Those assigned to the intervention group will receive electrical stimulation (ES) applied to the wrist extensors and wrist flexors twice a day, 5 days a week, for 3 months. The therapist (occupational therapist or physiotherapist) will identify the motor points for the forearm flexors and the extensors, and will place the electrode pads on these motor points using sticky pads. They will then connect the electrodes to the respective channels in the electrical stimulator. The ES will be set to deliver a 450µs pulse at a frequency of 40-60Hz (as per patient convenience). The intensity of the current will be increased to produce an alternating contraction of the flexors and extensors using a flex-hold-extend-hold pattern. A single stimulation and hold cycle will last 20 seconds and this will be cyclically repeated for 30 minutes after which the device can be removed.

Those assigned to the control group will receive usual care only and will not receive any ES treatment.

Participants in both arms of the trial will complete outcome assessments at baseline, 3, 6, and 12 months.

2. Patient and carer interviews:
Intervention group: 10 pairs of patient participants and their nominated carers will be interviewed about their experience of using or supporting a loved one to use electrical stimulation therapy as part of a research study. The interviews will be used to examine issues regarding compliance with the ES treatment regime, acceptability of the ES treatment, experience of supporting a stroke survivor in using the ES treatment, any perceived treatment effects, the training that was provided and the ongoing support needs and any issues related to recruitment and consent. The purpose of these interviews is to identify issues related to delivering ES

Primary Outcome(s)

The primary objective of the research is to evaluate the feasibility of running a randomised controlled trial that will test the efficacy of delivering early, intensive ES to prevent post stroke complications (such as pain and contractures) to the paretic (weak) upper limb after stroke.

The primary outcome measures:
1. Feasibility of the trial design (12 months) - Recruitment rates: number / % of participants recruited within 72 hours post-stroke; time post-stroke that participants received their first treatment; recruitment strategy: number / % of patients screened, number / % eligible and approached, number / % who consented, number / % excluded after screening; Completion rates: number / % of participants who completed the intervention; Number / % of participants who received ES twice a day, 5 days a week whilst in hospital, and number / % who continued with the treatment regime after discharge. Mean, min and max number of ES treatments that participants received during the 3 month intervention period; Recruitment of patients lacking mental capacity to consent for themselves: consultee consent rates (number / % of patients unable to give informed consent, and number consented by a consultee, number of consultees who declined consent).
2. Tolerability (12 months) – Proportion of participants who withdraw or decline intervention; records of interventions declined and why.
3. Integrity of the study protocol (12 months) – Measured by examining how many participants are able to complete the study, % of missing data, and % of people who completed each of the outcome measures at 3, 6 and 12 month follow-up, calculation of the cost of running the study.

Secondary Outcome(s)

1. NIHSS score (0, 3, 6, 12 months) – neurological outcome and degree of recovery
2. Barthel ADL Index score and modified Rankin score (0, 3, 6, 12 months) – Independence (functional ability) in basic daily activities
3. Scale of Pain Intensity (SPIN) (0, 3, 6, 12 months) – Pain in the affected arm
4. Muscle contractures (reduction in range of movement and spasticity) (0, 3, 6, 12 months) – muscle contractures will be monistored by measuring muscle activity during assessments using Biometrics equipment
5. Action Research Arm Test (ARAT) (0, 3, 6, 12 months) – arm function
6. Stroke Specific Quality of Life scale (SS-QOL) (0, 3, 6, 12 months) – stroke related quality of life
7. EuroQoL-5D (EQ-5D) (0, 3, 6, 12 months) – health status
8. Patient resource use (cost) questionnaire (0, 3, 6, 12 months) – a measure of resource use and health related costs
9. Caregiver strain Index (CSI) (0, 3, 6, 12 months) – Carer strain
10. Nottingham Extended ADL (NEADL) (0 months) – pre-morbid functional state
11. The Montreal Cognitive Assessment (MoCA) (0 months) – Cognitive status at baseline

Secondary ID(s)

Nil known

NCT02324634

18168

Source(s) of Monetary Support

National Institute for Health Research

Ethics review

Status:
Approval date:
Contact:

NRES Committee: East Midlands Nottingham 1, ref: 15/EM/0006

Results

• Results available: Yes
• Date Completed: 31/03/2018