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Completed

NCT Number: NCT01935687

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Djamel Bensmail

Garches, Hauts-de-Seine, 92380, France

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Using of instrumented wheel

Device

Using of instrumented wheel

Using of ergometer roller

Device

Using of ergometer roller

Primary outcomes

  1. Mechanical power calculated by instrumented wheel and ergometer roller.

    Time frame: 20 min

    Comparison between mechanical power calculated by the instrumented wheel and mechanical power calculated by ergometer roller.

Secondary outcomes

  1. Efficient fraction of total power calculated using instrumented wheel

    Time frame: 6 min

    Tangential power / total power

  2. Efficient fraction of total power calculated using ergometer roller

    Time frame: 15 min

    Tangential power / total power

Other outcomes

  1. Physiological parameters using instrumented wheel

    Time frame: 6 min

    Heart rate, VO2 and Borg score.

  2. Physiological parameters using ergometer roller

    Time frame: 15 min

    Heart rate, VO2 and Borg score.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: FRM

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Sep 5, 2013
Registry last updated
Nov 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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