Cross-over Study of Three Modular Devices for Aid in Patient Standing and Transfer

NCT01647802 | Completed

• 2 other identifiers: LOCAL/2012/EV-032012-A00638-35
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to evaluate via a physiological analysis of the movements involved in standing, the level of forward flexion of the spine (in cm on the horizontal axis) obtained with the apparatus "Tina" and to compare levels obtained in the same patients with stander/transfer devices "Turner" and "Vertic'Easy".

Conditions

Mobility Limitation

Keywords

standing devices; transfer devices

Outcome Measures

Primary Outcomes (1)

• Level of forward flexion of the spine (position of maximum horizontal displacement of C7)

  cm

  Baseline (Day 0; cross-sectional study)

Secondary Outcomes (4)

• Level of standing (maximum vertical displacement C7)

  Baseline (Day 0; transversal study)

• Angle of hip flexion (angle formed by the line connecting the acromion and the greater trochanter with the line connecting the greater trochanter and the lateral femoral condyle)

  Baseline (Day 0; transversal study)

• Standing time (time from start of forward flexion and the beginning of the vertical stabilization phase)

  Baseline (Day 0; transversal study)

• Verticalization achieved (yes/no)

  Baseline (Day 0; transversal study)

Study Arms (6)

Turner-Vertic'Easy-Tina

EXPERIMENTAL

Standing will be attempted with the three devices in the following order: (1) Turner; (2) Vertic'Easy; (3) Tina.

Device: Standing attempts with the "Vertic'Easy" Device; Device: Standing attempts with the "Turner" Device; Device: Standing attempts with the "Tina" device

Turner-Tina-Vertic'Easy

EXPERIMENTAL

Standing will be attempted with the three devices in the following order: (1) Turner; (2) Tina; (3) Vertic'Easy.

Device: Standing attempts with the "Vertic'Easy" Device; Device: Standing attempts with the "Turner" Device; Device: Standing attempts with the "Tina" device

Vertic'Easy-Turner-Tina

EXPERIMENTAL

Standing will be attempted with the three devices in the following order: (1) Vertic'Easy; (2) Turner; (3) Tina.

Device: Standing attempts with the "Vertic'Easy" Device; Device: Standing attempts with the "Turner" Device; Device: Standing attempts with the "Tina" device

Vertic'Easy-Tina-Turner

EXPERIMENTAL

Standing will be attempted with the three devices in the following order: (1) Vertic'Easy; (2) Tina; (3) Turner.

Device: Standing attempts with the "Vertic'Easy" Device; Device: Standing attempts with the "Turner" Device; Device: Standing attempts with the "Tina" device

Tina-Turner-Vertic'Easy

EXPERIMENTAL

Standing will be attempted with the three devices in the following order: (1) Tina; (2) Turner; (3) Vertic'Easy.

Device: Standing attempts with the "Vertic'Easy" Device; Device: Standing attempts with the "Turner" Device; Device: Standing attempts with the "Tina" device

Tina-Vertic'Easy-Turner

EXPERIMENTAL

Standing will be attempted with the three devices in the following order: (1) Tina; (2) Vertic'Easy; (3) Turner.

Device: Standing attempts with the "Vertic'Easy" Device; Device: Standing attempts with the "Turner" Device; Device: Standing attempts with the "Tina" device

Interventions

Standing attempts with the "Vertic'Easy" Device DEVICE

Included patients had never used any of the three devices evaluated in this study. Therefore the patient will make two attempts at standing on each device to enable him/her to get used to the device at the first attempt. A video recording will be made from a camera positioned laterally. Only the results of the second attempt will be a kinematic analysis and will be used for analyzes.

Also known as: Vertic'Easy, Manufacturer : HMS-VILGO, Parc Eurasanté - 243, Rue Salvador Allendé 59120 LOOS LEZ LILLE,

Tina-Turner-Vertic'Easy; Tina-Vertic'Easy-Turner; Turner-Tina-Vertic'Easy; Turner-Vertic'Easy-Tina; Vertic'Easy-Tina-Turner; Vertic'Easy-Turner-Tina

Standing attempts with the "Turner" Device DEVICE

Included patients had never used any of the three devices evaluated in this study. Therefore the patient will make two attempts at standing on each device to enable him/her to get used to the device at the first attempt. A video recording will be made from a camera positioned laterally. Only the results of the second attempt will be a kinematic analysis and will be used for analyzes

Also known as: Turner, Manufacturer : ETAC AB, Suède ; distributed in France by : FRANCE REHAB, ZA du Serroir, 54690 LAY SAINT CHRISTOPHE

Tina-Turner-Vertic'Easy; Tina-Vertic'Easy-Turner; Turner-Tina-Vertic'Easy; Turner-Vertic'Easy-Tina; Vertic'Easy-Tina-Turner; Vertic'Easy-Turner-Tina

Standing attempts with the "Tina" device DEVICE

Included patients had never used any of the three devices evaluated in this study. Therefore the patient will make two attempts at standing on each device to enable him/her to get used to the device at the first attempt. A video recording will be made from a camera positioned laterally. Only the results of the second attempt will be a kinematic analysis and will be used for analyzes

Also known as: Tina, Manufacturer : ALTER ECO Santé, 9 Boulevard de Maurens, 31270 CUGNAUX

Tina-Turner-Vertic'Easy; Tina-Vertic'Easy-Turner; Turner-Tina-Vertic'Easy; Turner-Vertic'Easy-Tina; Vertic'Easy-Tina-Turner; Vertic'Easy-Turner-Tina

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• The patient must have given his/her informed and signed consent
• The patient must be insured or beneficiary of a health insurance plan
• The patient is in stable medical condition (no complications in the last 10 days)
• The patient is unable to stand up by his/her self and requires help during transfers
• The patient has muscular force (quadriceps) \> 3 out of 5.

You may not qualify if:

• The patient is participating in another study
• The patient is under judicial protection, under tutorship or curatorship
• The patient refuses to sign the consent
• It is impossible to correctly inform the patient
• The patient is pregnant, parturient, or breastfeeding
• The patient has a limited support from at least one lower limb
• The patient has an unstable fracture
• The patient has a fragile heart
• The patient has joint pain localized in the knee, hip or ankle.
• The patient has already used one of three mechanisms to help with standing and transfer used in this study
• Behavioral problems (opposition, agitation)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emilie Viollet, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2012
• First Posted: July 24, 2012
• Study Start: September 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: March 26, 2015

Record last verified: 2015-03

Locations

FR (1)