NCT01422278

Brief Summary

Evaluating the effects in functional status after three weeks of cognitive - and behavioural rehabilitation on patients with gait disorder. The patients are followed up as after 1 and 12 months to study if any improvement is still present. The patients are being recruited from neurological units. The intervention is explanation of symptoms, positive reinforcement of normal behaviour and absence reinforcement of dysfunctional behaviour. In addition the study aims at describing typical gait patterns at patients with gait disorder by using biomechanical measurements (EKG).

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
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2007

Longer than P75 for phase_1

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2006

Completed
1.6 years until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
12 months until next milestone

First Posted

Study publicly available on registry

August 23, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

August 23, 2011

Status Verified

August 1, 2011

Enrollment Period

3 years

First QC Date

January 16, 2006

Last Update Submit

August 22, 2011

Conditions

Conversion Disorder

Outcome Measures

Primary Outcomes (1)

  • Change in gait patterns

    three weeks

Secondary Outcomes (1)

  • Improved life quality

    12 months

Interventions

RehabilitationOTHER

Three weeks of rehabilitation in Hospital.

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To determine the changes in functional status after three weeks of multidisciplinary rehabilitation in patients with conversion walking disorder.

You may not qualify if:

  • Essential gait disorders do to conversion symptoms and willingness to participate in either of the two groups with informed consent are required.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vestfold Hospital Trust, clinic physical medicine and rehabilitation

Stavern, Vestfold, 3290, Norway

Location

MeSH Terms

Conditions

Conversion Disorder

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Somatoform DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Georg Høyer, DH

    National committees for research ethics in Norway" for REK

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

January 16, 2006

First Posted

August 23, 2011

Study Start

September 1, 2007

Primary Completion

September 1, 2010

Study Completion

December 1, 2011

Last Updated

August 23, 2011

Record last verified: 2011-08

Locations

NO(1)