Electrical Stimulation of the Paretic Upper Limb in the Early Stroke Phase

NCT02250365 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2017-08-18

No results posted yet for this study

Summary

This study evaluates the effect of electrical somatosensory stimulation (ESS) on the restoration of upper limb functioning in acute stroke patients. The effect will be measured at the end of the intervention and six months post-stroke. We expect that ESS facilitates the restoration of upper limb functioning and the brain reorganization following stroke.

Conditions

  • Stroke, Acute

Interventions

OTHER

Continuous, suprasensory ESS

1 hour of ESS daily from Monday to Sunday during hospitalization, but no longer than 4th week post-stroke. The ESS will be applied immediately prior to OT/PT training which will include 15 minutes of repetitive, task-oriented upper limb training during the first 30 minutes after cessation of ESS.

OTHER

Intermittent, suprasensory ESS

1 hour of ESS daily from Monday to Sunday during hospitalization, but no longer than 4th week post-stroke. The ESS will be applied immediately prior to OT/PT training which will include 15 minutes of repetitive, task-oriented upper limb training during the first 30 minutes after cessation of ESS.

Sponsors & Collaborators

  • Bispebjerg Hospital

    collaborator OTHER
  • Region Capital Denmark

    collaborator OTHER
  • Lundbeck Foundation

    collaborator OTHER
  • Bevica Fonden

    collaborator OTHER
  • Manager Jacob Madsen and his wife, Olga Madsen's Foundation

    collaborator UNKNOWN
  • Danish Association of Occupational Therapist

    collaborator OTHER
  • University of Copenhagen

    lead OTHER

Principal Investigators

  • Peter Magnusson, D.Sc · Musculoskeletal Rehabilitation Research Unit and Institute of Sports Medicine, Bispebjerg Hospital & University of Copenhagen

  • Emma Ghaziani, PhD stud · Musculoskeletal Rehabilitation Research Unit, Bispebjerg Hospital & University of Copenhagen

  • Christian Couppé, PhD · Musculoskeletal Rehabilitation Research Unit and Institute of Sports Medicine, Bispebjerg Hospital & University of Copenhagen

  • Hanne Christensen, MD, PhD · Bispebjerg Hospital & University of Copenhagen

  • Volkert Siersma, statistician · Research Unit Of General Practice, Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-13
Primary Completion
2017-08-10
Completion
2017-08-10

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02250365 on ClinicalTrials.gov