- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02767466
Affective Responses in Neurological Rehabilitation
May 9, 2016 updated by: Martin Burtscher, Universitaet Innsbruck
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
16
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with neurological disorders
Description
Inclusion Criteria:
- voluntary participation
- neurological incident
Exclusion Criteria:
- lack of communication ability
- interference of consciousness
- inability to speak German language
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
G
All participants were randomly exposed to two different treatments:
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change of subscales of mood survey scale from pre to post treatment
Time Frame: 30-60 minutes
|
30-60 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Martin Kopp, Prof, Univeryity of Innsbruck
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
April 22, 2016
First Submitted That Met QC Criteria
May 9, 2016
First Posted (Estimate)
May 10, 2016
Study Record Updates
Last Update Posted (Estimate)
May 10, 2016
Last Update Submitted That Met QC Criteria
May 9, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APTRAGT001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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