NCT02250365

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 26, 2014

Completed
17 days until next milestone

Study Start

First participant enrolled

October 13, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2017

Completed
Last Updated

August 18, 2017

Status Verified

August 1, 2017

Enrollment Period

2.8 years

First QC Date

September 18, 2014

Last Update Submit

August 15, 2017

Conditions

Stroke, Acute

Keywords

stroke, acuteupper extremityrehabilitationelectric stimulation therapy

Outcome Measures

Primary Outcomes (1)

  • Box and Block Test

    Performance test

    at 6 months post-stroke

Secondary Outcomes (11)

  • Fugl-Meyer Assessment (upper limb section)

    at hospital discharge, but not later than 4 weeks post-stroke

  • Fugl-Meyer Assessment (upper limb section)

    at 6 months post-stroke

  • Hand grip strength

    at hospital discharge, but not later than 4 weeks post-stroke

  • Hand grip strength

    6 months post-stroke

  • Palmar, lateral and thumb-to-index pinch strength

    at hospital discharge, but not later than 4 weeks post-stroke

  • +6 more secondary outcomes

Study Arms (2)

Continuous, suprasensory ESS

EXPERIMENTAL
Other: Continuous, suprasensory ESS

Intermittent, suprasensory ESS

ACTIVE COMPARATOR
Other: Intermittent, suprasensory ESS

Interventions

Continuous, suprasensory ESSOTHER

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.

Continuous, suprasensory ESS
Intermittent, suprasensory ESSOTHER

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.

Intermittent, suprasensory ESS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • admission at the rehabilitation stroke unit of Bispebjerg Hospital, Copenhagen,
  • diagnosis of acute stroke (ICD 10 code: 163.9, 161.9),
  • residence in the hospitals' catchment area,
  • age \> 18 years,
  • modified Rankin Scale score \< 5,
  • ESS can be initiated within 7 days post-stroke,
  • a subscore \< 66 on section A-D of Fugl-Meyer Assessment Upper Extremity,

You may not qualify if:

  • presence of cognitive dysfunctions or poor communication skills in Danish that limit the ability of providing informed consent,
  • have participated in other biomedical, intervention studies within the last 3 months,
  • contraindication to ESS (e.g. pacemaker, significant skin impairment on the paretic arm),
  • incomplete recovery of the affected upper limb after previous stroke,
  • patients who - because of placement in an institution, incarceration pursuant to the Psychiatric Act or due to circumstances of employment - are particularly exposed to pressure regarding participation in the project.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Bispebjerg Hospital

Copenhagen, Region Sjælland, 2400, Denmark

Location

Neurological Rehabilitation Centre Copenhagen & other rehabilitation and health care institutions

Copenhagen, Region Sjælland, 2400, Denmark

Location

Lioba & Rehabilitation Centre Valby & Heath Centre Stockflethsvej & other rehabilitation and health care institutions

Frederiksberg, Region Sjælland, 2000, Denmark

Location

Related Publications (3)

  • Ghaziani E, Couppe C, Siersma V, Christensen H, Magnusson SP, Sunnerhagen KS, Persson HC, Alt Murphy M. Easily Conducted Tests During the First Week Post-stroke Can Aid the Prediction of Arm Functioning at 6 Months. Front Neurol. 2020 Jan 9;10:1371. doi: 10.3389/fneur.2019.01371. eCollection 2019.

    PMID: 31993016DERIVED

  • Ghaziani E, Couppe C, Siersma V, Sondergaard M, Christensen H, Magnusson SP. Electrical Somatosensory Stimulation in Early Rehabilitation of Arm Paresis After Stroke: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2018 Oct;32(10):899-912. doi: 10.1177/1545968318799496. Epub 2018 Sep 25.

    PMID: 30251591DERIVED

  • Ghaziani E, Couppe C, Henkel C, Siersma V, Sondergaard M, Christensen H, Magnusson SP. Electrical somatosensory stimulation followed by motor training of the paretic upper limb in acute stroke: study protocol for a randomized controlled trial. Trials. 2017 Feb 23;18(1):84. doi: 10.1186/s13063-017-1815-9.

    PMID: 28231811DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Peter Magnusson, D.Sc

    Musculoskeletal Rehabilitation Research Unit and Institute of Sports Medicine, Bispebjerg Hospital & University of Copenhagen

    STUDY DIRECTOR

  • Emma Ghaziani, PhD stud

    Musculoskeletal Rehabilitation Research Unit, Bispebjerg Hospital & University of Copenhagen

    PRINCIPAL INVESTIGATOR

  • Christian Couppé, PhD

    Musculoskeletal Rehabilitation Research Unit and Institute of Sports Medicine, Bispebjerg Hospital & University of Copenhagen

    PRINCIPAL INVESTIGATOR

  • Hanne Christensen, MD, PhD

    Bispebjerg Hospital & University of Copenhagen

    PRINCIPAL INVESTIGATOR

  • Volkert Siersma, statistician

    Research Unit Of General Practice, Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

September 18, 2014

First Posted

September 26, 2014

Study Start

October 13, 2014

Primary Completion

August 10, 2017

Study Completion

August 10, 2017

Last Updated

August 18, 2017

Record last verified: 2017-08

Locations

DK(3)