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Completed

NCT Number: NCT03117699

Seated - Standing Passage of the Hemiplegic

This is a study for a new mechanical transport device adapted to the hemiplegic patients.

Healthy volunteers :

After explaining the protocol and presenting the movement laboratory, the subjects are equipped with reflective markers on the 4 limbs, the trunk and the head. The subjects are installed on a seat positioned in front of 2 force platforms installed on the ground. The seat is equipped with a force platform.

Phase 1 :

After being seated, the subject realizes :

* 3 seat to stand and stand to seat without assistance * 3 seat to stand and stand to seat using a handle located in front of it (handle equipped with a 6-axis force sensor) * 3 seat to stand and stand to seat using the experimental device This phase will last 45minutes (mn) (30mn of equipment and 15mn of sitting passengers standing)

Phase 2:

After being seated, the subject performs a course comprising:

* A standing pass from sitting on a chair * A straight line movement * A succession of left and right turns * An upward and downward travel of less than 1%. * Standard doorway * Standing on the toilet * A sitting pass from the toilet * One way to a bed * A sitting pass on the bed * A passenger seat sitting upright from the bed * A return to the starting point * A sitting pass on the starting chair Each stage is timed. A subjective analysis of each step is done by a lickert scale on the perceived comfort and safety.

This phase 2 will last 30mn (15mn of course and 15mn of questions).

Hemiplegic subjects :

At each session, the subject is examined by a physician who evaluates the motor control (Fugl Meyer scale), the equilibrium (Berg scale) and the spatial hemineglect (Bergego scale).

Phase 1 is performed except the 3 seat to stand and stand to seat without assistance which are impossible.

Phase 2 is performed. An evaluation of the device over 4 hours is carried out for each subject in therapeutic apartment in simulated living conditions. The validation in living lab is carried out by an ergonomist and by a questionnaire on the comfort and safety of the various steps identified by the ergonomist.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brest University Hospital, Brest, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy volunteers :

  • aged 18-75 years
  • Subject having given his consent
  • Free from any neurological or cardiorespiratory locomotor pathology that may interfere with standing seated passages.

Hemiplegic patients :

  • Left hemiplegia in one of the following groups :
  • Walking with difficulty or not walking and able to stand with a stick or an armrest
  • Walking difficult or not walking and unable to stand with a cane or an armrest.
  • aged 18-90 years
  • Subject having given his consent
  • Subjects with a trunk balance to sit without support

Exclusion criteria

  • aged less than 18 or more than 75 (healthy volunteers) or more than 90 (hemiplegic subjects)
  • Pain during seated-standing passages
  • Unstable medical condition
  • Unable to consent
  • Subject under legal protection
  • Left-hemineglect making standing or seated (wheelchair) displacements impossible autonomously (for hemiplegic patients)

Treatment and study plan

New device for seated-standing passages

Device

Phase 1 : The subject perform different seated-standing passages (see "Arm")

Phase 2 : After being seated, the subject performs a course comprising:

  • A standing pass from sitting on a chair
  • A straight line movement
  • A succession of left and right turns
  • An upward and downward travel of less than 1%.
  • Standard doorway
  • Standing on the toilet
  • A sitting pass from the toilet
  • One way to a bed
  • A sitting pass on the bed
  • A passenger seat sitting upright from the bed
  • A return to the starting point
  • A sitting pass on the starting chair

Primary outcomes

  1. Time required to carry out each step of use of the device

    Time frame: Day 1

    Each step of phase 1 and phase 2 will be timed.

Secondary outcomes

  1. Record of all adverse reactions.

    Time frame: Day 1

    The safety of the devices will be evaluated by the occurrence of adverse reactions.

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

Continuation of the Exploration of the Standing Seated Passage of the Hemiplegic for the Realization of a New Transport Device

Acronym: PADH2

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 18, 2017
Registry last updated
Mar 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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