NCT02767466

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2012

Status
completed

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

Study Start

First participant enrolled

December 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

April 22, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 10, 2016

Completed
Last Updated

May 10, 2016

Status Verified

May 1, 2016

Enrollment Period

Same day

First QC Date

April 22, 2016

Last Update Submit

May 9, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change of subscales of mood survey scale from pre to post treatment

    30-60 minutes

Study Arms (1)

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.

Procedure: Physical therapy and robotic assisted gait training

Interventions

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with neurological disorders

You may qualify if:

  • voluntary participation
  • neurological incident

You may not qualify if:

  • lack of communication ability
  • interference of consciousness
  • inability to speak German language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

StrokeBrain Injuries, Traumatic

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain InjuriesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Martin Kopp, Prof

    Univeryity of Innsbruck

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof Martin Burtscher

Study Record Dates

First Submitted

April 22, 2016

First Posted

May 10, 2016

Study Start

December 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

May 10, 2016

Record last verified: 2016-05