Rehabilitation of Conversion Gait Disorder | NCT01422278

Studies
Rehabilitation of Conversion Gait Disorder

NCT01422278

Sponsor

Oslo University Hospital

Status

Unknown status

Last Update Posted

Aug 23, 2011Estimated

Enrollment

60Estimated

Phase

Phase 1Phase 2

Conditions

Conversion Disorder

Interventions

Rehabilitation

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
SSR.2005.1

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Sep 2010Actual

Completion Date

Dec 2011Estimated

First Submitted Date

Jan 16, 2006

First Submission Date that Met QC Criteria

Aug 22, 2011

First Posted Date

Aug 23, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2011

Last Update Posted Date

Aug 23, 2011Estimated

Name	Class
Norwegian School of Sport Sciences	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Patients are being recruited from neurological unit/ div and out patients department of SSR and are randomized to treatment or control group. Essential gait disorders do to conversion symptoms and willingness to participate in either of the two groups with informed consent are required.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rehabilitation	Other	Three weeks of rehabilitation in Hospital.

Measure	Description	Time Frame
Change in gait patterns		three weeks

Measure	Description	Time Frame
Improved life quality		12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

69 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Georg Høyer, DH	National committees for research ethics in Norway" for REK	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vestfold Hospital Trust, clinic physical medicine and rehabilitation		Stavern	Vestfold	3290	Norway

Condition Browse Module

MeSH Terms

ID	Term
D003291	Conversion Disorder

Ancestor Terms

ID	Term
D013001	Somatoform Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012046	Rehabilitation

Ancestor Terms

ID	Term
D000359	Aftercare
D003266	Continuity of Patient Care
D005791	Patient Care
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided