Early Electrical Stimulation to Prevent Complications in the Arm Post-stroke - a Feasibility Study

NCT02324634 | Unknown

• 1 other identifier: 14110
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is the largest cause of adult disability in the United Kingdom. Loss of hand function, muscle weakness, pain, and joint deformities are persistent and disabling problems for nearly half of all stroke survivors. This can, in part, result from patients not getting adequate therapy targeting the hand and arm in the very early stages of rehabilitation. Previous research has highlighted the importance of early rehabilitation interventions after stroke. Although in stroke patients the damage is to the brain rather than the limbs, muscle wastage (atrophy) can occur soon after stroke through non-use. Muscle atrophy can even occur in those who have retained some degree of active arm movement. Electrical stimulation (ES) is a painless treatment in which small pulses of electrical current from a battery operated portable device are used to activate a paralysed muscle and produce a strong muscle contraction. ES has been shown to increase brain activity and can hence influence the formation of new nerve pathways (known as neuroplasticity) to replace those damaged by stroke. Previous studies have concluded that six weeks of ES to the muscle on the back of the forearm improved the chance of a person recovering arm function. However, as the intensity of treatment was not sufficient to prevent the complications identified in this proposal, the impact of any functional benefit was significantly limited. We plan to build on previous research by training clinical therapists to operate ES devices; starting ES much earlier after stroke; applying a higher intensity treatment to more of the forearm muscles (i.e. both the front and back of the forearm) and providing treatment for a longer period of time than previously carried out. We will evaluate the feasibility of incorporating ES into a patient self-management programme to enable independent use outside of routine therapist led rehabilitation sessions.

Conditions

Stroke

Outcome Measures

Primary Outcomes (3)

• Feasibility of the trial design

  Recruitment rates: No./% of participants recruited within 72 hours post-stroke; and time post-stroke that participants received their first treatment; Recruitment strategy: No./% of patients screened, No./% eligible and approached, No./% who consented, No./% excluded after screening; Completion rates: No./% of participants who completed the intervention; No./% who completed the 3, 6 and 12 month follow-up assessments; Feasibility of delivering the intervention: No./% of participants who received ES twice a day, 5 days a week whilst in hospital, and No./% who continued with the treatment regime after discharge. Mean, min and max no. 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 (No./% of patients unable to give informed consent, and no. consented by a consultee, no. of consultees who declined consent)

  12 months

• Tolerability

  Proportion of participants who withdraw or decline intervention; Record of interventions declined and why.

  12 months

• Integrity of the study protocol

  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.

  12 months

Secondary Outcomes (12)

• NIHSS score

  0, 3, 6, 12 months

• Barthel ADL Index score and modified Rankin Score

  0, 3, 6, 12 months

• Scale of Pain Intensity (SPIN)

  0, 3, 6, 12 months

• Muscle contractures (reduction in range of movement and spasticity)

  0, 3, 6, 12 months

• Action Research Arm Test (ARAT)

  0, 3, 6, 12 months

Study Arms (2)

ES intervention

EXPERIMENTAL

Electrical stimulation (ES) twice a day, 5 days a week, for 3 months

Device: NeuroTrac Rehab dual channel device

Control

NO INTERVENTION

Usual care only

Interventions

NeuroTrac Rehab dual channel device DEVICE

ES intervention twice a day, 5 days a week, for 3 months applied to the wrist extensors and wrist flexors. The therapist will identify the motor points for the forearm flexors and the extensors, and will place an electrode 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.

Also known as: Electrical stimulation rehabilitation intervention

ES intervention

Eligibility Criteria

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

You may qualify if:

• Patients with a confirmed clinical diagnosis of stroke AND it is their first stroke event to affect their upper limb
• Patients aged 18 years or over
• 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)

You may not qualify if:

• 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
• 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.
• Patients with a cardiac pacemaker or similar implanted device.
• Pregnancy
• Epilepsy
• Undiagnosed pain or skin conditions (i.e. not related to the stroke)
• Carer participants for the main feasibility RCT eligibility criteria:
• Nominated carer for a patient participating in the feasibility RCT
• Non English speaking
• Patient and carer interviews eligibility criteria:
• Patients or carers who are participating in the main feasibility RCT
• mental capacity to consent and take part in the interview
• Able to understand English
• Unable to communicate verbally or in written form
• Non-English speaking

Sponsors & Collaborators

• University of Nottingham: lead
• Keele University: collaborator
• University of Southampton: collaborator
• Nottingham University Hospitals NHS Trust: collaborator

Study Sites (1)

Nottingham University Hospitals NUH Foundation Trust - Stroke Unit

Nottingham, Nottinghamshire, NG16 1RS, United Kingdom

Location

Related Publications (1)

• Fletcher-Smith JC, Walker DM, Sprigg N, James M, Walker MF, Allatt K, Mehta R, Pandyan AD. ESCAPS study protocol: a feasibility randomised controlled trial of 'Early electrical stimulation to the wrist extensors and wrist flexors to prevent the post-stroke complications of pain and contractures in the paretic arm'. BMJ Open. 2016 Jan 4;6(1):e010079. doi: 10.1136/bmjopen-2015-010079.

  PMID: 26729394 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Joanna C Fletcher-Smith, PhD; MPhil; BSc

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: As this is a feasibility RCT, the outcome assessor has not been masked to treatment but would be in a subsequent pilot and definitive trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: December 24, 2014
• Study Start: June 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: May 5, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)