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

NCT ID: NCT02244931

Last Updated: 2014-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2014-08-31

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.

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.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Servomatic™ assisting device

Intervention Type: DEVICE

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

E.Motion© assisting device

Intervention Type: DEVICE

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

Standard manual Wheelchair

Intervention Type: DEVICE

Standard manual Wheelchair

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

Group Type: EXPERIMENTAL

Servomatic™ assisting device

Intervention Type: DEVICE

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

E.Motion© assisting device

Intervention Type: DEVICE

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

Standard manual Wheelchair

Intervention Type: DEVICE

Standard manual Wheelchair

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

Group Type: EXPERIMENTAL

Servomatic™ assisting device

Intervention Type: DEVICE

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

E.Motion© assisting device

Intervention Type: DEVICE

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

Standard manual Wheelchair

Intervention Type: DEVICE

Standard manual Wheelchair

Interventions

Servomatic™ assisting device

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

Intervention Type: DEVICE

E.Motion© assisting device

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

Intervention Type: DEVICE

Standard manual Wheelchair

Standard manual Wheelchair

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nadine NP PELLEGRINI, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Physical Medicine and Rehabilitation, Raymond Poincaré Hospital

Garches, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 25620717 (View on PubMed)

Other Identifiers

2011-A00151-40

Identifier Type: -

Identifier Source: org_study_id