NCT01139034

Brief Summary

The purpose of this study is to investigate the effects of the self-designed surface functional electrical stimulator on shoulder joint subluxation for stroke patients

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
3

participants targeted

Target at below P25 for phase_1 stroke

Timeline
Completed

Started Mar 2010

Shorter than P25 for phase_1 stroke

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

June 22, 2010

Status Verified

June 1, 2010

Enrollment Period

9 months

First QC Date

June 7, 2010

Last Update Submit

June 20, 2010

Conditions

Outcome Measures

Primary Outcomes (1)

  • Upward migration index

    1 year

Secondary Outcomes (1)

  • Acromiohumeral distance

    1 year

Study Arms (1)

shoulder FES treatment

EXPERIMENTAL
Device: Self-designed surface functional electrical stimulator

Interventions

Use the self-designed surface functional electrical stimulator to improve the shoulder joint subluxation.

Also known as: Self-designed surface functional electrical stimulation
shoulder FES treatment

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • stroke (1-3 months)
  • Brunnstrom Stage I-III
  • single, unilateral

You may not qualify if:

  • aphasic
  • shoulder impairment
  • severe osteoporosis
  • cardiac arrhythmias or having a pacemaker implanted
  • abnormal cutaneous sensation at the target areas

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Medicine and Rehabilitation, NTUH

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Jin-Shin Lai, MD

    Department of Physical Medicine and Rehabilitation, NTUH, Taipei, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 7, 2010

First Posted

June 8, 2010

Study Start

March 1, 2010

Primary Completion

December 1, 2010

Study Completion

March 1, 2011

Last Updated

June 22, 2010

Record last verified: 2010-06

Locations