Neurological IncidentsNCT02767466
Affective Responses in Neurological Rehabilitation
An observational study of Neurological Incidents and Stroke, run by Universitaet Innsbruck.
Trial summary
Using a single blind within-subject design, 16 patients with neurological disorders were randomly exposed to two different treatments: physical therapy and robotic assisted gait training. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neurological Incidents, Stroke, Traumatic Brain Injury
- What is being tested?
- Physical therapy and robotic assisted gait training
- Type of treatment
- Surgery or procedure
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Dec 2012
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with neurological disorders
Who may be able to join
- voluntary participation
- neurological incident
Who cannot join
- lack of communication ability
- interference of consciousness
- inability to speak German language
About this study
Official title: A Preliminary Study on Acute Affective Responses Focussing on Differences Between Physical Therapy and Robotic Assisted Gait Training
Using a single blind within-subject design, 16 patients with neurological disorders were randomly exposed to two different treatments: physical therapy and robotic assisted gait training. Both before and after the treatments, a self-report Mood Survey Scale (MSS) was used to assess the effects on the treatment on distinct affective states. The subscales of the MSS were tested for pre-post changes and different effects between treatments with non-parametric tests.
- Conditions
- Neurological Incidents, Stroke, Traumatic Brain Injury
- Being tested
- Physical therapy and robotic assisted gait training
- Medical subject headings
- Stroke, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapy and robotic assisted gait trainingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| G | All participants were randomly exposed to two different treatments:
* Conventional physical therapy (no specific device used)
* Robotic assisted gait training (Lokomat, Hocoma AG, Switzerland)
We consider the study as observational, since the both interventions of the study (physical therapy, robotic assisted gait training) did not change in the patients' usual therapy plan, as they received both interventions daily.
We only added diagnostic interventions to assess the affective responses. Receives: Procedure: Physical therapy and robotic assisted gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of subscales of mood survey scale from pre to post treatment
Measured: 30-60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study startDec 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological IncidentsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaet Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Burtscher, Universitaet Innsbruck
- Investigators
- Martin Kopp, Prof, Study director, Univeryity of Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02767466
- Sponsor's protocol ID
- APTRAGT001
- Status last verified
- May 2016
- First submitted
- 22 Apr 2016
- Last updated
- 10 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Study on Acute Affective Responses Focussing on Differences Between Physical Therapy and Robotic Assisted Gait Training
- ClinicalTrials.gov ID
- NCT02767466
- Acronym / sponsor ID
- APTRAGT001
- Conditions
- Neurological Incidents, Stroke, Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Universitaet InnsbruckUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 10 May 2016 (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.
Using a single blind within-subject design, 16 patients with neurological disorders were randomly exposed to two different treatments: physical therapy and robotic assisted gait training. Both before and after the treatments, a self-report Mood Survey Scale (MSS) was used to assess the effects on the treatment on distinct affective states. The subscales of the MSS were tested for pre-post changes and different effects between treatments with non-parametric tests.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| G | – | Procedure: Physical therapy and robotic assisted gait trainingAll participants were randomly exposed to two different treatments: * Conventional physical therapy (no specific device used) * Robotic assisted gait training (Lokomat, Hocoma AG, Switzerland) We consider the study as observational, since the both interventions of the study (physical therapy, robotic assisted gait training) did not change in the patients' usual therapy plan, as they received both interventions daily. We only added diagnostic interventions to assess the affective responses. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with neurological disorders
Key inclusion criteria (2 listed)
- voluntary participation
- neurological incident
Key exclusion criteria (3 listed)
- lack of communication ability
- interference of consciousness
- inability to speak German language
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 |
|---|---|---|
| Physical therapy and robotic assisted gait training | Procedure or surgery | G |
Primary outcome
Change of subscales of mood survey scale from pre to post treatment
Time frame: 30-60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2016.
Related trials for Neurological Incidents
RecruitingObservational study
Efficacy of Xeomin for Migraines in Patients With Traumatic Brain Injuries vs. Anomalous Health Incidents
Migraine, Traumatic Brain Injury
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.
Martin Kopp, Prof study director
Univeryity of Innsbruck
Questions about this trial
What is this clinical trial studying?
An observational study of Neurological Incidents and Stroke, run by Universitaet Innsbruck.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 10 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 of subscales of mood survey scale from pre to post treatment (time frame: 30-60 minutes). 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 10 May 2016.