Clinical Evaluation of Instrumented Wheel as Biomedical Device Quantifying the Displacement Efficiency

Not Applicable

Completed

• Conditions: Spinal Cord Injury

• Registration Number: NCT01935687
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The purpose of this study is to validate an instrumented wheel such as a new biomedical device. The physicians will compare this instrumented wheel with another instrumentation "Ergometer roller", each patient will try the both instrumentations, physical and physiological parameters will be measured.

The increase rate of radial power during the cardiac stress test may be more important when the physicians use the instrumented wheel.

Detailed Description

\* The manual wheelchair is used by people for whom walking is difficult or impossible due to spinal cord lesions, neurological and muscular diseases, lower limb trauma, age ...etc.

Although the wheelchair help to regain mobility, this made of displacement is nor natural nor well-to-do.

* The CIC-IT and TSR (Transmissions Services Roulements, Mérignac, France) improved the instrumented wheel, adaptable with all wheelchairs, with information wireless transmission.

* The primary objective of study is to validate the instrumented wheel of manual wheelchair such as a new device of evaluation of capacities of displacement in ecologic situation.

* The primary criteria is to compare the mechanical power calculated using instrumented wheel versus the power calculated using ergometer roller during protocol of standard cardio-respiratory stress test.

This study is interventional, mono-centric, controlled and crossover. The population concerned is patients with spinal cord injury (SCI) and users of manual wheelchair.

Number of subjects projected for the entire study: 62 patients The total duration of participation of each patient: 7 days ±2days

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-03-04
• Study First Submitted QC: 2013-09-02
• Study First Posted: 2013-09-05
• Primary Completion: 2014-04
• Study Completion: 2015-07
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-17
• Last Update Posted: 2017-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Age : 18-70 years.
• Spinal cord injured patient.
• User of manual wheelchair for daily locomotion (having at least 30/100 at displacement items of WST questionnaire) .
• Affiliation to a social security scheme or entitled.
• Informed consent dated and signed by subject or subject's legally acceptable representative (and investigator).

Exclusion Criteria

• Cognitive troubles.
• Progressive diseases: Tumoral, infectious, inflammatory and associated pathologies: brain injury, amputation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Mechanical power calculated by instrumented wheel and ergometer roller.	20 min	Comparison between mechanical power calculated by the instrumented wheel and mechanical power calculated by ergometer roller.

Secondary Outcome Measures

Name	Time	Method
Efficient fraction of total power calculated using instrumented wheel	6 min	Tangential power / total power
Efficient fraction of total power calculated using ergometer roller	15 min	Tangential power / total power

Trial Locations

Locations (1)

Djamel Bensmail; 🇫🇷 Garches, Hauts-de-Seine, France