NCT02244931

Brief Summary

The purpose of this study is to compare three assisting devices to propel personal wheelchairs (Servomatic A©, Servomatic B© and E.Motion©) to the standard personal manual wheelchair in patients with spinal cord injury.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 19, 2014

Completed
Last Updated

September 19, 2014

Status Verified

September 1, 2013

Enrollment Period

2.9 years

First QC Date

September 15, 2014

Last Update Submit

September 17, 2014

Conditions

Spinal Cord Injuries

Keywords

Spinal cord injuries, paraplegic, manual wheelchairs, assisting propelling device

Outcome Measures

Primary Outcomes (3)

  • Phase 1: physiological parameters : Oxygen consumption.

    3 hours

  • Phase 2: Ease of crossing obstacles assessed by patients with a Visual Analog Scale

    3 hours

  • Phase 3: Time necessary to transfer from wheelchair to car and from car to wheelchair.

    3 hours

Study Arms (3)

Phase 1: Performance evaluation on ergometer

EXPERIMENTAL

The 3 devices are experimented in random order to compare them on performance using an ergometer wheelchair: * Servomatic™ assisting device * E.Motion© assisting device * Standard manual Wheelchair

Device: Servomatic™ assisting deviceDevice: E.Motion© assisting deviceDevice: Standard manual Wheelchair

Phase 2: Comparison of maneuverability

EXPERIMENTAL

The 3 devices are experimented in random order to compare them on maneuverability: * Servomatic™ assisting device * E.Motion© assisting device * Standard manual Wheelchair

Device: Servomatic™ assisting deviceDevice: E.Motion© assisting deviceDevice: Standard manual Wheelchair

Phase 3: Comparison of the autonomy

EXPERIMENTAL

The 3 devices are experimented in random order to compare them on the autonomy they afford to patients: * Servomatic™ assisting device * E.Motion© assisting device * Standard manual Wheelchair

Device: Servomatic™ assisting deviceDevice: E.Motion© assisting deviceDevice: Standard manual Wheelchair

Interventions

Servomatic™ assisting deviceDEVICE

Servomatic™ is an hand controlled motorized device assisting to propel the wheelchair .

Phase 1: Performance evaluation on ergometerPhase 2: Comparison of maneuverabilityPhase 3: Comparison of the autonomy
E.Motion© assisting deviceDEVICE

E.Motion© is an hand controlled motorized device assisting to propel the wheelchair .

Phase 1: Performance evaluation on ergometerPhase 2: Comparison of maneuverabilityPhase 3: Comparison of the autonomy
Standard manual WheelchairDEVICE

Standard manual Wheelchair

Phase 1: Performance evaluation on ergometerPhase 2: Comparison of maneuverabilityPhase 3: Comparison of the autonomy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women aged between 18 and 70 years
  • Spinal cord injury C5-C8, paraplegic D1-D11, and D11 paraplegic below only for phases 1 and 2 phase 1 and 2
  • Spinal cord injury D1 and above only for phase 3
  • Having given free and informed consent
  • Negative pregnancy test for women of childbearing age

You may not qualify if:

  • No affiliation to a social security scheme
  • Refusal to participate in the clinical trial
  • Patient under guardianship
  • Major cognitive disorders
  • bedsores
  • Functional abnormality of the shoulder
  • History of cardiovascular disease
  • ECG to suspect coronary insufficiency
  • Pregnant patients without effective treatment or contraceptive
  • Acute complication or systemic organ

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical Medicine and Rehabilitation, Raymond Poincaré Hospital

Garches, 92380, France

Location

Related Publications (1)

  • Guillon B, Van-Hecke G, Iddir J, Pellegrini N, Beghoul N, Vaugier I, Figere M, Pradon D, Lofaso F. Evaluation of 3 pushrim-activated power-assisted wheelchairs in patients with spinal cord injury. Arch Phys Med Rehabil. 2015 May;96(5):894-904. doi: 10.1016/j.apmr.2015.01.009. Epub 2015 Jan 22.

    PMID: 25620717DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Nadine NP PELLEGRINI, MD

    Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, 92380 Garches, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2014

First Posted

September 19, 2014

Study Start

September 1, 2011

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

September 19, 2014

Record last verified: 2013-09

Locations

FR(1)