NCT00858910

Brief Summary

The purpose of the study is to examine if patients in the embedded motor imagery (MI) training group (EG1) need less time to perform the motor task than patients in the added MI training group (EG2).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_2 stroke

Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_2 stroke

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

March 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 10, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

October 25, 2013

Status Verified

July 1, 2010

Enrollment Period

1.2 years

First QC Date

March 9, 2009

Last Update Submit

October 24, 2013

Conditions

Stroke

Keywords

Motor imageryMotor skillPerformance improvement

Outcome Measures

Primary Outcomes (1)

  • Time in seconds to perform a motor task: "Going down, laying on the floor and getting up again."

    2 weeks

Secondary Outcomes (5)

  • Further outcome measures: - Help needed to perform the task, scored on a 7-item scale (1 total help, 7 completely independent) - Stage of motor task (one out of 13 possible stages)

    2 weeks

  • Motor impairment and independence measured with the extended Barthel index (EBI).

    2 weeks

  • Balance measured with the Berg Balance Scale (BBS).

    2 weeks

  • Motor imagery ability measured with the kinesthetic and visual motor imagery questionnaire (KVIQ) and the 'Imaprax 1.1' software.

    2 weeks

  • Fear of falling (FOF) is measured with the Activities-Specific Balance Confidence Scale (ABC-scale).

    2 weeks

Study Arms (3)

EG1: embedded MI

EXPERIMENTAL

Experimental group 1: Participants receive motor imagery (MI) training included in 45min physiotherapy, 3 times per week for 2 weeks.

Other: Motor imagery (MI) training

EG2: added MI

EXPERIMENTAL

Experimental group 2: Participants receive a 15 minutes motor imagery (MI) training added to a 30 min physiotherapy session, 3 times a week for two weeks.

Other: Motor imagery (MI) training

CG

PLACEBO COMPARATOR

Control group: Participants receive a 15 min control intervention added to their 30 min physiotherapy session, 3 times a week for two weeks.

Other: Control intervention

Interventions

Motor imagery (MI) trainingOTHER

MI training encloses the internal rehearsal of a known motor skill without any overt motor output.

EG1: embedded MIEG2: added MI
Control interventionOTHER

The control intervention encloses relaxation and breathing exercises, and information about: * the disease (stroke), * therapy options, * self-help groups and their offers for support, * helping aids for independent living at home.

CG

Eligibility Criteria

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

You may qualify if:

  • Patients after a first-ever ischemic or hemorrhagic stroke
  • Outpatients or leaving inpatients 3 months after stroke
  • Ability to stand with or without a cane for at least 30 sec on a normal hard floor
  • Ability to walk for 20 metres with or without a cane or an orthosis
  • MMSE with at least 20 points
  • Age older than 18 years
  • Signed written informed consent

You may not qualify if:

  • Joint replacements (knee, hip, shoulder)
  • Limiting pain in the upper or lower body
  • Limiting range of motion (ROM) in the hip, knee, ankle joint or toes
  • Body weight more than 90 kilograms
  • Compromised mental capacity to give written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation centre: Reha Rheinfelden

Rheinfelden, Canton of Aargau, 4310, Switzerland

Location

Related Publications (3)

  • Zimmermann-Schlatter A, Schuster C, Puhan MA, Siekierka E, Steurer J. Efficacy of motor imagery in post-stroke rehabilitation: a systematic review. J Neuroeng Rehabil. 2008 Mar 14;5:8. doi: 10.1186/1743-0003-5-8.

    PMID: 18341687BACKGROUND

  • Schuster C, Butler J, Andrews B, Kischka U, Ettlin T. Comparison of embedded and added motor imagery training in patients after stroke: results of a randomised controlled pilot trial. Trials. 2012 Jan 23;13:11. doi: 10.1186/1745-6215-13-11.

    PMID: 22269834DERIVED

  • Schuster C, Butler J, Andrews B, Kischka U, Ettlin T. Comparison of embedded and added motor imagery training in patients after stroke: study protocol of a randomised controlled pilot trial using a mixed methods approach. Trials. 2009 Oct 22;10:97. doi: 10.1186/1745-6215-10-97.

    PMID: 19849835DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 9, 2009

First Posted

March 10, 2009

Study Start

March 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

October 25, 2013

Record last verified: 2010-07

Locations

CH(1)