Seated - Standing Passage of the Hemiplegic

NCT03117699 | Completed

• 1 other identifier: 29BRC16.0012 PADH2
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hemiplegia

Keywords

Hemiplegia; transport device

Outcome Measures

Primary Outcomes (1)

• Time required to carry out each step of use of the device

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

  Day 1

Secondary Outcomes (1)

• Record of all adverse reactions.

  Day 1

Study Arms (2)

Hemiplegic subjects

EXPERIMENTAL

Testing of a new device for seated-standing passages after undergoing medical evaluation included Fugl Meyer scale, Berg scale and Bergego scale. Phase 1 : * 3 seated-standing passages with a handle equipped with 6 force captors * 3 seated-standing passages with the device

Device: New device for seated-standing passages

Healthy volunteers

EXPERIMENTAL

Testing of a new device for seated-standing passages . Phase 1 : * 3 seated-standing passages without help * 3 seated-standing passages with a handle equipped with 6 force captors * 3 seated-standing passages with the device

Device: New device for seated-standing passages

Interventions

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

Healthy volunteers; Hemiplegic subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (2)

Brest University Hospital

Brest, 29200, France

Location

Centre de rééducation fonctionnelle de KERPAPE

Ploemeur, 56000, France

Location

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 18, 2017
• Study Start: April 13, 2017
• Primary Completion: April 13, 2018
• Study Completion: April 13, 2018
• Last Updated: March 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)