Seated - Standing Passage of the Hemiplegic

NCT ID: NCT03117699

Last Updated: 2022-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-13
• Study Completion Date: 2018-04-13

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Hemiplegic subjects

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

Group Type: EXPERIMENTAL

New device for seated-standing passages

Intervention Type: 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

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

Group Type: EXPERIMENTAL

New device for seated-standing passages

Intervention Type: 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

Interventions

New device for seated-standing passages

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

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Brest University Hospital

Brest, , France

Centre de rééducation fonctionnelle de KERPAPE

Ploemeur, , France

Countries

France

Other Identifiers

29BRC16.0012 PADH2

Identifier Type: -

Identifier Source: org_study_id