Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00011853

Trial Description

start of 1:1-Block title

Title

Feasibility of inertial sensor-based real-time gait feedback therapy in individuals after stroke, with spinal cord injury and age-related gait disorders

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

RehaGait

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Various diseases and lesions of the central nervous system can cause lasting gait disabilities. Unphysiological gait patterns lead to unnatural loading of muscles and joints and can cause pain and further gait disability in the medium and long term. In sport and rehabilitation, verbal feedback about the unnatural gait is applied by therapists or trainers. In this study we employ a technical, mobile feedback system to feed back deviations from a physiological gait pattern to patients with gait disabilities in order to give them the opportunity to actively normalize this pattern. The results of this study are used to verify if this method is feasible as an improved gait therapy. Participants with gait disabilities with incomplete spinal cord injury, stroke, Parkinson's disease and elderly (>65 years) are included.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Aim of this study is to test the feasibility of inertial sensor-based real-time feedback (FB) therapy in individuals with unphysiological gait pattern due to incomplete spinal cord injury (iSCI), stroke and conditions related to old age.
In a bi-centric proof-of-concept study, individuals with unphysiological gait pattern train one pre-chosen gait parameter (stride length, stance or wing time, or angle between foot and ground at heel strike) using automated verbalized FB generated by a shoe mounted sensor system and a tablet PC. The training phase consists of 3 consecutive training visits and 1 follow-up visit 4 weeks post training. Training visits start with an initial gait analysis (iGA) with FB turned off, followed by 5 FB training runs of 2-3 min and end with another gait analysis. A parameter and individual independent level structure servs as evaluation criterion for the distance of the parameter to a physiological reference as well as for automated adaptation of training difficulty. Main outcome parameter is the mean level at iGA of visits 1 through 3. Participant feedback is obtained by a customized QUEST survey.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00011853
  •   2017/03/23
  •   [---]*
  •   yes
  •   Approved
  •   S-168/2015, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   sensorimotor incomplete spinal cord injury
  •   stroke
  •   unphysiological gait pattern due to old age (geriatric patients)
  •   I69.4 -  Sequelae of stroke, not specified as haemorrhage or infarction
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   5x 2-3 min feedback training per visit. Three training visits take place on 3 consecutive days. The feedback system consisting of 2 shoe-mounted inertial sensors and 1 tablet PC calculates relevant gait parameters and generates verbal feedback about the distance to a physiological norm in a pre-chosen training parameter. This feedback is presented on every third heel strike. One feedback announcement consists of the trained parameter, e.g. "stance duration", the strength of feedback, e.g. "much", and the direction of change towards the physiological norm, e.g. "shorter".
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Change in mean training level (1 level = 1 SD of the physiological norm of the chosen training parameter) at initial gait analysis of visits 1 through 3.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Improvement in gait speed in the 10-Meter-Walk-Test on even ground without FB before and after the training phase of the study.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2015/07/20
  •   45
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Patients with spinal cord injury:
age ≥ 18 years;
motor incomplete (ASIA Impairment Scale (AIS) C, D);
time after injury > 6 weeks;
minimum walking ability: 20 min, WISCI II ≥ 10;
leg braces: maximal ankle support;
6 Min-Test ≥ 100 m.

Patients after stroke:
age ≥ 18 years;
Mini-Mental-Status-Test (MMST) score ≥ 18 ;
time after paralysis > 3 months;
minimum walking ability: 20 min;
leg braces: maximal ankle support;
6 Min-Test ≥ 100 m.

Geriatric patients:
age ≥ 65 years;
minimum walking ability: 20 min.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Patients with spinal cord injury and patients with stroke:
difference in leg length > 3 cm;
extreme spasticity, MAS (unilaterally) ≥ 10;
epileptic seizures;
severe cognitive impairment.

Geriatric patients:
severe dementia;
persisting stroke symptoms;
insecure usage of walking aids (walker, walking stick).

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Paraplegiologie - Experimentelle Neurorehabilitation
    • Mr.  Dr.-ing.  Rüdiger  Rupp 
    • Schlierbacher Landstraße 200a
    • 69118  Heidelberg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Klinik für Paraplegiologie - Expermimentelle Neurorehabilitation
    • Mr.  Dr.  Rüdiger  Rupp 
    • Schlierbacher Landstraße 200 a
    • 69118  Heidelberg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Experimentelle Neurorehabilitation, Klinik für Paraplegiologie, Universitätsklinikum Heidelberg
    • Mr.  Daniel  Schließmann 
    • Schlierbacher Landstraße 200a
    • 69118  Heidelberg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • AiF Projekt GmbH, Projektträger des Bundesministeriums für Wirtschaft und Engie
    • Tschaikowskistraße 49
    • 13156  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2016/11/30
end of 1:1-Block state
* This entry means the parameter is not applicable or has not been set.