Conversion DisorderPhase 1/2NCT01422278
Rehabilitation of Conversion Gait Disorder
A Phase 1/2 study testing Rehabilitation in people with Conversion Disorder, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Conversion Disorder
- What is being tested?
- Rehabilitation
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2007to Dec 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To determine the changes in functional status after three weeks of multidisciplinary rehabilitation in patients with conversion walking disorder.
Who cannot join
- Essential gait disorders do to conversion symptoms and willingness to participate in either of the two groups with informed consent are required.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Vestfold Hospital Trust, clinic physical medicine and rehabilitation
Stavern, Vestfold, 3290
About this study
Official title: Patients With Conversion Gait Disorder - Effect on Treatment and Common Gait Patterns. Randomized Clinical Trial
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).
Read the 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.
- Conditions
- Conversion Disorder
- Being tested
- Rehabilitation
- Medical subject headings
- Conversion Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
Three weeks of rehabilitation in Hospital.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gait patterns
Measured: three weeks
Secondary outcomes (1)
Improved life quality
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study startSep 2007
- Primary completionSep 2010
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conversion DisorderStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian School of Sport Sciences
- Responsible party
- Principal investigator, Annika A. Jordbru, Oslo University Hospital
- Investigators
- Georg Høyer, DH, Study chair, National committees for research ethics in Norway" for REK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422278
- Sponsor's protocol ID
- 2.2004.164
- Other IDs
- SSR.2005.1
- Status last verified
- Aug 2011
- First submitted
- 16 Jan 2006
- Last updated
- 23 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients With Conversion Gait Disorder - Effect on Treatment and Common Gait Patterns. Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01422278
- Acronym / sponsor ID
- 2.2004.164
- Conditions
- Conversion Disorder
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Norwegian School of Sport Sciences
- Study start
- Sep 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Dec 2011 (estimated)
- First posted
- 23 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- To determine the changes in functional status after three weeks of multidisciplinary rehabilitation in patients with conversion walking disorder.
Key exclusion criteria (1 listed)
- Essential gait disorders do to conversion symptoms and willingness to participate in either of the two groups with informed consent are required.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RehabilitationThree weeks of rehabilitation in Hospital. | Other | – |
Primary outcome
Change in gait patterns
Time frame: three weeks
1 secondary outcome
Improved life quality
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georg Høyer, DH study chair
National committees for research ethics in Norway" for REK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Rehabilitation in people with Conversion Disorder, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gait patterns (time frame: three weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2011.