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Comparison of Three Different Assisting Devices to Power Manual Wheelchairs in Patients With Spinal Cord Injury (PAPAW)

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ClinicalTrials.gov Identifier: NCT02244931
Recruitment Status : Completed
First Posted : September 19, 2014
Last Update Posted : September 19, 2014
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Device: Servomatic™ assisting device Device: E.Motion© assisting device Device: Standard manual Wheelchair Not Applicable

Detailed Description:

The objective of the 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.

The study consists of three distinct and independent phases:

  • Phase 1: Performance evaluation on wheelchair ergometer in order to compare the energy expenditure and kinetic characteristics in comparable situations with regard to speed and workload imposed to the wheelchair-patient couple.
  • Phase 2: Comparison of maneuverability and ease of crossing usual obstacles in outdoor and indoor paths with standardised obstacles. Trajectories are to be recorded in order to allow analysis by independent experts.
  • Phase 3: Comparison of the autonomy of patients afforded by the devices by comparing the patient's ability to transfer from wheelchair to car seat and from car seat to wheelchair, as well as ease of wheelchair packing in car, in the context of a standard city transport involving a car and the wheelchair.

The three phases are to be performed using the standard manual wheelchair and the three assisting devices in a randomized order.

Three different groups of patients are included in the three phases of the study.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Comparison of Three Assisting Devices to Power Manual Wheelchairs in Patients With Spinal Cord Injury : Assessment of Biomechanical, Physiological and Functional Properties.
Study Start Date : September 2011
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Phase 1: Performance evaluation on ergometer

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

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

Device: Standard manual Wheelchair
Standard manual Wheelchair

Experimental: Phase 2: Comparison of maneuverability

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

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

Device: Standard manual Wheelchair
Standard manual Wheelchair

Experimental: Phase 3: Comparison of the autonomy

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

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

Device: Standard manual Wheelchair
Standard manual Wheelchair




Primary Outcome Measures :
  1. Phase 1: physiological parameters : Oxygen consumption. [ Time Frame: 3 hours ]
  2. Phase 2: Ease of crossing obstacles assessed by patients with a Visual Analog Scale [ Time Frame: 3 hours ]
  3. Phase 3: Time necessary to transfer from wheelchair to car and from car to wheelchair. [ Time Frame: 3 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02244931


Locations
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France
Physical Medicine and Rehabilitation, Raymond Poincaré Hospital
Garches, France, 92380
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Nadine NP PELLEGRINI, MD Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, 92380 Garches, France

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02244931     History of Changes
Other Study ID Numbers: 2011-A00151-40
First Posted: September 19, 2014    Key Record Dates
Last Update Posted: September 19, 2014
Last Verified: September 2013

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Spinal cord injuries, paraplegic, manual wheelchairs, assisting propelling device

Additional relevant MeSH terms:
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Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System