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

Spinal Cord Injuries Clinical Trial

— PAPAW  

Official title:

Comparison of Three Assisting Devices to Power Manual Wheelchairs in Patients With Spinal Cord Injury : Assessment of Biomechanical, Physiological and Functional Properties.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02244931
• Other study ID #: 2011-A00151-40
• Status: Completed
• Phase: N/A
• First received: September 15, 2014
• Last updated: September 17, 2014
• Start date: September 2011
• Est. completion date: August 2014

Study information

• Verified date: September 2013
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Device:
• Servomatic™ assisting device
Servomatic™ is an hand controlled motorized device assisting to propel the wheelchair .
• E.Motion© assisting device
E.Motion© is an hand controlled motorized device assisting to propel the wheelchair .
• Standard manual Wheelchair
Standard manual Wheelchair

Locations

Country	Name	City	State
France	Physical Medicine and Rehabilitation, Raymond Poincaré Hospital	Garches

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1: physiological parameters : Oxygen consumption.		3 hours	No
Primary	Phase 2: Ease of crossing obstacles assessed by patients with a Visual Analog Scale		3 hours	No
Primary	Phase 3: Time necessary to transfer from wheelchair to car and from car to wheelchair.		3 hours	No