We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02324634
Recruitment Status : Unknown
Verified May 2017 by University of Nottingham.
Recruitment status was:  Active, not recruiting
First Posted : December 24, 2014
Last Update Posted : May 5, 2017
Keele University
University of Southampton
Nottingham University Hospitals NHS Trust
Information provided by (Responsible Party):
University of Nottingham

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.

Condition or disease Intervention/treatment Phase
Stroke Device: NeuroTrac Rehab dual channel device Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: 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.
Primary Purpose: Treatment
Official 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
Actual Study Start Date : June 1, 2015
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: ES intervention
Electrical stimulation (ES) twice a day, 5 days a week, for 3 months
Device: NeuroTrac Rehab dual channel 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.
Other Name: Electrical stimulation rehabilitation intervention

No Intervention: Control
Usual care only

Primary Outcome Measures :
  1. Feasibility of the trial design [ Time Frame: 12 months ]
    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)

  2. Tolerability [ Time Frame: 12 months ]
    Proportion of participants who withdraw or decline intervention; Record of interventions declined and why.

  3. Integrity of the study protocol [ Time Frame: 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 Measures :
  1. NIHSS score [ Time Frame: 0, 3, 6, 12 months ]
    Neurological outcome and degree of recovery from stroke

  2. Barthel ADL Index score and modified Rankin Score [ Time Frame: 0, 3, 6, 12 months ]
    Independence (functional ability) in basic daily activities

  3. Scale of Pain Intensity (SPIN) [ Time Frame: 0, 3, 6, 12 months ]
    Pain in the affected arm

  4. Muscle contractures (reduction in range of movement and spasticity) [ Time Frame: 0, 3, 6, 12 months ]
    Muscle contractures (reduction in range of movement and spasticity) will be monitored by measuring muscle activity during assessments using Biometrics equipment

  5. Action Research Arm Test (ARAT) [ Time Frame: 0, 3, 6, 12 months ]
    Arm function

  6. Stroke Specific Quality of Life Scale (SS-QOL) [ Time Frame: 0, 3, 6, 12 months ]
    Stroke related quality of life

  7. EuroQoL-5D (EQ-5D) [ Time Frame: 0, 3, 6, 12 months ]
    Health status

  8. Patient resource questionnaire [ Time Frame: 0, 3, 6, 12 months ]
    A measure of resource use and health related costs

  9. Caregiver Strain Index (CSI) [ Time Frame: 0, 3, 6, 12 months ]
    Carer strain

  10. Nottingham Extended ADL (NEADL) [ Time Frame: 0 months ]
    Pre-morbid functional state

  11. The Montreal Cognitive Assessment (MoCA) [ Time Frame: 0 months ]
    Cognitive status at baseline

  12. Patient resource use (cost) questionnaire [ Time Frame: 0, 3, 6, 12 months ]
    A questionnaire to measure resource use and associated health costs.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Main feasibility RCT eligibility criteria:

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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:

Inclusion Criteria:

  • Nominated carer for a patient participating in the feasibility RCT

Exclusion Criteria:

  • Non English speaking

Patient and carer interviews eligibility criteria:

Inclusion 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

Exclusion Criteria:

  • Unable to communicate verbally or in written form
  • Non-English speaking
  • Aged younger than 18 years

Therapist Focus Discussion Groups:

Inclusion criteria:

  • HCPC registered occupational therapist or physiotherapist
  • Currently employed by NUH NHS Trust and working on the Nottingham Stroke Unit
  • Experience of supporting at least one participant to use the ES intervention

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02324634

Layout table for location information
United Kingdom
Nottingham University Hospitals NUH Foundation Trust - Stroke Unit
Nottingham, Nottinghamshire, United Kingdom, NG16 1RS
Sponsors and Collaborators
University of Nottingham
Keele University
University of Southampton
Nottingham University Hospitals NHS Trust
Layout table for investigator information
Principal Investigator: Joanna C Fletcher-Smith, PhD; MPhil; BSc University of Nottingham
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT02324634    
Other Study ID Numbers: 14110
First Posted: December 24, 2014    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases