Evaluation of Positioning Protocols on a Wheelchair in Hemiplegic Patients

NCT04268641 | Completed

• 1 other identifier: GHIV0417
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 7

Brief Summary

The main purpose of this study is to assess the interest of using wheelchair positioning equipment on the decrease of postural disorders, compared to the standard use of a wheelchair

Conditions

Hemiplegia And/or Hemiparesis Following Stroke

Keywords

Hemiplegia; Stroke; Wheelchair positioning; Propulsion; Pelvic posterior tilt; Obliquity

Outcome Measures

Primary Outcomes (1)

• Degree of pelvic posterior tilt

  The Primary Outcome Measure is the variation of the Degree of pelvic posterior tilt at the end of the three standardized course. These courses were performed with Standard Wheelchair, Standard Wheelchair + Seat back + Positioning cushion + Belt or with Standard Wheelchair + Seat back + Positioning cushion. The Degree of pelvic posterior tilt was measured using the SPCMA 2.0 score (0 = normal, 1 = mild, 2 = moderate and 3 = severe retroversion)

  Immediately after the end of the procedure, an average of 1 day

Secondary Outcomes (8)

• Variation of Degree of pelvic posterior tilt

  Baseline and immediately after the end of the procedure, an average of 1 day

• Variation of degree of lateral inclination of the torso

  Baseline and immediately after the end of the procedure, an average of 1 day

• Variation of the degree of Pelvis obliquity

  Baseline and immediately after the end of the procedure, an average of 1 day

• Degree of lateral inclination of the torso

  Immediately after the end of the procedure, an average of 1 day

• Degree of Pelvis obliquity

  Immediately after the end of the procedure, an average of 1 day

Study Arms (6)

Use of positioning equipment order 1

EXPERIMENTAL

One standardized course is performed 3 times by each patient : one with a standard wheelchair and the 2 other with one or two positioning equipment (Seat back or/and positioning cushion) Each arm differs from the previous by the order of use of the equipment.

Other: Arm 1

Use of positioning equipment order 2

EXPERIMENTAL

One standardized course is performed 3 times by each patient : one with a standard wheelchair and the 2 other with one or two positioning equipment (Seat back or/and positioning cushion) Each arm differs from the previous by the order of use of the equipment.

Other: Arm 2

Use of positioning equipment order 3

EXPERIMENTAL

One standardized course is performed 3 times by each patient : one with a standard wheelchair and the 2 other with one or two positioning equipment (Seat back or/and positioning cushion) Each arm differs from the previous by the order of use of the equipment.

Other: Arm 3

Use of positioning equipment order 4

EXPERIMENTAL

One standardized course is performed 3 times by each patient : one with a standard wheelchair and the 2 other with one or two positioning equipment (Seat back or/and positioning cushion) Each arm differs from the previous by the order of use of the equipment.

Other: Arm 4

Use of positioning equipment order 5

EXPERIMENTAL

One standardized course is performed 3 times by each patient : one with a standard wheelchair and the 2 other with one or two positioning equipment (Seat back or/and positioning cushion) Each arm differs from the previous by the order of use of the equipment.

Other: Arm 5

Use of positioning equipment order 6

EXPERIMENTAL

One standardized course is performed 3 times by each patient : one with a standard wheelchair and the 2 other with one or two positioning equipment (Seat back or/and positioning cushion) Each arm differs from the previous by the order of use of the equipment.

Other: Arm 6

Interventions

Arm 1 OTHER

Materials used for the course : 1. : Standard Wheelchair 2. : Standard Wheelchair + Seat back + Positioning cushion 3. : Standard Wheelchair + Seat back + Positioning cushion + Belt

Use of positioning equipment order 1

Arm 2 OTHER

Materials used for the course : 1. : Standard Wheelchair 2. : Standard Wheelchair + Seat back + Positioning cushion + Belt 3. : Standard Wheelchair + Seat back + Positioning cushion

Use of positioning equipment order 2

Arm 3 OTHER

Materials used for the course : 1. : Standard Wheelchair + Seat back + Positioning cushion 2. : Standard Wheelchair + Seat back + Positioning cushion + Belt 3. : Standard Wheelchair

Use of positioning equipment order 3

Arm 4 OTHER

Materials used for the course : 1. : Standard Wheelchair + Seat back + Positioning cushion 2. : Standard Wheelchair 3. : Standard Wheelchair + Seat back + Positioning cushion + Belt

Use of positioning equipment order 4

Arm 5 OTHER

Materials used for the course : 1. : Standard Wheelchair + Seat back + Positioning cushion + Belt 2. : Standard Wheelchair 3. : Standard Wheelchair + Seat back + Positioning cushion

Use of positioning equipment order 5

Arm 6 OTHER

Materials used for the course : 1. : Standard Wheelchair + Seat back + Positioning cushion + Belt 2. : Standard Wheelchair + Seat back + Positioning cushion 3. : Standard Wheelchair

Use of positioning equipment order 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hemiplegic patient following a stroke
• Hospitalized in a follow-up and rehabilitative care service, after hospital stays in a MCO service (neurology, neurosurgery or reanimation)
• With a planned exit from hospital (homecoming, residential care facilities, nursing home, Long Term Care Unit …)
• Patient whose wheelchair choice should be already done
• Patient who propels the wheelchair with the valid hand and/or valid foot
• Written informed consent (IC) obtained
• Patients with affiliation to the social security system

You may not qualify if:

• Good walk recovery (FAC scale \>3)
• Wheelchair with a double hand rim
• Patient who cannot use his2 wheelchair independently
• Cognitive disorders which prevent the ability to well understanding the instructions
• Other pathology which can interfere with this protocol (Spinal disorder, morbid overweight (BMI\>40…)

Sponsors & Collaborators

• Hôpital NOVO: lead

Study Sites (7)

Groupement Hospitalier Intercommunal du Vexin

Aincourt, 95510, France

Location

Hôpital Raymond Poincaré

Garche, 92380, France

Location

Institut Régional de Réadaptation

Lay-Saint-Christophe, 54690, France

Location

Centre de l'ESPOIR

Lille, 59260, France

Location

Centre de Rééducation L'oiseau Blanc

Mantes-la-Jolie, 78200, France

Location

Centre de Rééducation et de Réadaptation Fonctionnelles

Menucourt, 95180, France

Location

Centre Hospitalier Universitaire de Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Hemiplegia; Stroke

Interventions

DMAC2L protein, human

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nadine Pellegrini

  Groupement Hospitalier Intercommunal du Vexin

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 13, 2020
• Study Start: August 28, 2020
• Primary Completion: December 11, 2023
• Study Completion: December 11, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)